65
526 42 CFR Ch. I (10–1–97 Edition) Pt. 84 PART 84—APPROVAL OF RESPIRATORY PROTECTIVE DEVICES Subpart A—General Provisions Sec. 84.1 Purpose. 84.2 Definitions. 84.3 Respirators for mine rescue or other emergency use in mines. Subpart B—Application for Approval 84.10 Application procedures. 84.11 Contents of application. 84.12 Delivery of respirators and compo- nents by applicant; requirements. Subpart C—Fees 84.20 Examination, inspection, and testing of complete respirator assemblies; fees. 84.21 Examination, inspection, and testing of respirator components or subassem- blies; fees. 84.22 Unlisted fees; additional fees; payment by applicant prior to approval. Subpart D—Approval and Disapproval 84.30 Certificates of approval; scope of ap- proval. 84.31 Certificates of approval; contents. 84.32 Notice of disapproval. 84.33 Approval labels and markings; ap- proval of contents; use. 84.34 Revocation of certificates of approval. 84.35 Changes or modifications of approved respirators; issuance of modification of certificate of approval. 84.36 Delivery of changed or modified ap- proved respirator. Subpart E—Quality Control 84.40 Quality control plans; filing require- ments. 84.41 Quality control plans; contents. 84.42 Proposed quality control plans; ap- proval by the Institute. 84.43 Quality control records; review by the Institute; revocation of approval. Subpart F—Classification of Approved Res- pirators; Scope of Approval; Atmos- pheric Hazards; Service Time 84.50 Types of respirators to be approved; scope of approval. 84.51 Entry and escape, or escape only; clas- sification. 84.52 Respiratory hazards; classification. 84.53 Service time; classification. Subpart G—General Construction and Performance Requirements 84.60 Construction and performance require- ments; general. 84.61 General construction requirements. 84.62 Component parts; minimum require- ments. 84.63 Test requirements; general. 84.64 Pretesting by applicant; approval of test methods. 84.65 Conduct of examinations, inspections, and tests by the Institute; assistance by applicant; observers; recorded data; pub- lic demonstrations. 84.66 Withdrawal of applications; refund of fees. Subpart H—Self-Contained Breathing Apparatus 84.70 Self-contained breathing apparatus; description. 84.71 Self-contained breathing apparatus; required components. 84.72 Breathing tubes; minimum require- ments. 84.73 Harnesses; installation and construc- tion; minimum requirements. 84.74 Apparatus containers; minimum re- quirements. 84.75 Half-mask facepieces, full facepieces, mouthpieces; fit; minimum require- ments. 84.76 Facepieces; eyepieces; minimum re- quirements. 84.77 Inhalation and exhalation valves; min- imum requirements. 84.78 Head harnesses; minimum require- ments. 84.79 Breathing gas; minimum require- ments. 84.80 Interchangeability of oxygen and air prohibited. 84.81 Compressed breathing gas and lique- fied breathing gas containers; minimum requirements. 84.82 Gas pressure gages; minimum require- ments. 84.83 Timers; elapsed time indicators; re- maining service life indicators; minimum requirements. 84.84 Hand-operated valves; minimum re- quirements. 84.85 Breathing bags; minimum require- ments. 84.86 Component parts exposed to oxygen pressures; minimum requirements. 84.87 Compressed gas filters; minimum re- quirements. 84.88 Breathing bag test. 84.89 Weight requirement. 84.90 Breathing resistance test; inhalation. 84.91 Breathing resistance test; exhalation. 84.92 Exhalation valve leakage test. 84.93 Gas flow test; open-circuit apparatus.

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526

42 CFR Ch. I (10–1–97 Edition)Pt. 84

PART 84—APPROVAL OFRESPIRATORY PROTECTIVE DEVICES

Subpart A—General Provisions

Sec.84.1 Purpose.84.2 Definitions.84.3 Respirators for mine rescue or other

emergency use in mines.

Subpart B—Application for Approval

84.10 Application procedures.84.11 Contents of application.84.12 Delivery of respirators and compo-

nents by applicant; requirements.

Subpart C—Fees

84.20 Examination, inspection, and testingof complete respirator assemblies; fees.

84.21 Examination, inspection, and testingof respirator components or subassem-blies; fees.

84.22 Unlisted fees; additional fees; paymentby applicant prior to approval.

Subpart D—Approval and Disapproval

84.30 Certificates of approval; scope of ap-proval.

84.31 Certificates of approval; contents.84.32 Notice of disapproval.84.33 Approval labels and markings; ap-

proval of contents; use.84.34 Revocation of certificates of approval.84.35 Changes or modifications of approved

respirators; issuance of modification ofcertificate of approval.

84.36 Delivery of changed or modified ap-proved respirator.

Subpart E—Quality Control

84.40 Quality control plans; filing require-ments.

84.41 Quality control plans; contents.84.42 Proposed quality control plans; ap-

proval by the Institute.84.43 Quality control records; review by the

Institute; revocation of approval.

Subpart F—Classification of Approved Res-pirators; Scope of Approval; Atmos-pheric Hazards; Service Time

84.50 Types of respirators to be approved;scope of approval.

84.51 Entry and escape, or escape only; clas-sification.

84.52 Respiratory hazards; classification.84.53 Service time; classification.

Subpart G—General Construction andPerformance Requirements

84.60 Construction and performance require-ments; general.

84.61 General construction requirements.84.62 Component parts; minimum require-

ments.84.63 Test requirements; general.84.64 Pretesting by applicant; approval of

test methods.84.65 Conduct of examinations, inspections,

and tests by the Institute; assistance byapplicant; observers; recorded data; pub-lic demonstrations.

84.66 Withdrawal of applications; refund offees.

Subpart H—Self-Contained BreathingApparatus

84.70 Self-contained breathing apparatus;description.

84.71 Self-contained breathing apparatus;required components.

84.72 Breathing tubes; minimum require-ments.

84.73 Harnesses; installation and construc-tion; minimum requirements.

84.74 Apparatus containers; minimum re-quirements.

84.75 Half-mask facepieces, full facepieces,mouthpieces; fit; minimum require-ments.

84.76 Facepieces; eyepieces; minimum re-quirements.

84.77 Inhalation and exhalation valves; min-imum requirements.

84.78 Head harnesses; minimum require-ments.

84.79 Breathing gas; minimum require-ments.

84.80 Interchangeability of oxygen and airprohibited.

84.81 Compressed breathing gas and lique-fied breathing gas containers; minimumrequirements.

84.82 Gas pressure gages; minimum require-ments.

84.83 Timers; elapsed time indicators; re-maining service life indicators; minimumrequirements.

84.84 Hand-operated valves; minimum re-quirements.

84.85 Breathing bags; minimum require-ments.

84.86 Component parts exposed to oxygenpressures; minimum requirements.

84.87 Compressed gas filters; minimum re-quirements.

84.88 Breathing bag test.84.89 Weight requirement.84.90 Breathing resistance test; inhalation.84.91 Breathing resistance test; exhalation.84.92 Exhalation valve leakage test.84.93 Gas flow test; open-circuit apparatus.

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527

Public Health Service, HHS Pt. 84

84.94 Gas flow test; closed-circuit appara-tus.

84.95 Service-time test; open-circuit appara-tus.

84.96 Service-time test; closed-circuit appa-ratus.

84.97 Test for carbon dioxide in inspired gas;open- and closed-circuit apparatus; maxi-mum allowable limits.

84.98 Tests during low temperature oper-ation.

84.99 Man tests; testing conditions; generalrequirements.

84.100 Man tests 1, 2, 3, and 4; requirements.84.101 Man test 5; requirements.84.102 Man test 6; requirements.84.103 Man tests; performance requirements.84.104 Gas tightness test; minimum require-

ments.

Tables to Subpart H of Part 84

Subpart I—Gas Masks

84.110 Gas masks; description.84.111 Gas masks; required components.84.112 Canisters and cartridges in parallel;

resistance requirements.84.113 Canisters and cartridges; color and

markings; requirements.84.114 Filters used with canisters and car-

tridges; location; replacement.84.115 Breathing tubes; minimum require-

ments.84.116 Harnesses; installation and construc-

tion; minimum requirements.84.117 Gas mask containers; minimum re-

quirements.84.118 Half-mask facepieces, full facepieces,

and mouthpieces; fit; minimum require-ments.

84.119 Facepieces; eyepieces; minimum re-quirements.

84.120 Inhalation and exhalation valves;minimum requirements.

84.121 Head harnesses; minimum require-ments.

84.122 Breathing resistance test; minimumrequirements.

84.123 Exhalation valve leakage test.84.124 Facepiece tests; minimum require-

ments.84.125 Particulate tests; canisters contain-

ing particulate filters; minimum require-ments.

84.126 Canister bench tests; minimum re-quirements.

Tables to Subpart I of Part 84

Subpart J—Supplied-Air Respirators

84.130 Supplied-air respirators; description.84.131 Supplied-air respirators; required

components.84.132 Breathing tubes; minimum require-

ments.

84.133 Harnesses; installation and construc-tion; minimum requirements.

84.134 Respirator containers; minimum re-quirements.

84.135 Half-mask facepieces, full facepieces,hoods, and helmets; fit; minimum re-quirements.

84.136 Facepieces, hoods, and helmets; eye-pieces; minimum requirements.

84.137 Inhalation and exhalation valves;check valves; minimum requirements.

84.138 Head harnesses; minimum require-ments.

84.139 Head and neck protection; supplied-air respirators; minimum requirements.

84.140 Air velocity and noise levels; hoodsand helmets; minimum requirements.

84.141 Breathing gas; minimum require-ments.

84.142 Air supply source; hand-operated ormotor driven air blowers; Type A sup-plied-air respirators; minimum require-ments.

84.143 Terminal fittings or chambers; TypeB supplied-air respirators; minimum re-quirements.

84.144 Hand-operated blower test; minimumrequirements.

84.145 Motor-operated blower test; mini-mum requirements.

84.146 Method of measuring the power andtorque required to operate blowers.

84.147 Type B supplied-air respirator; mini-mum requirements.

84.148 Type C supplied-air respirator, con-tinuous-flow class; minimum require-ments.

84.149 Type C supplied-air respirator, de-mand and pressure demand class; mini-mum requirements.

84.150 Air-supply line tests; minimum re-quirements.

84.151 Harness test; minimum requirements.84.152 Breathing tube test; minimum re-

quirements.84.153 Airflow resistance test, Type A and

Type AE supplied-air respirators; mini-mum requirements.

84.154 Airflow resistance test; Type B andType BE supplied-air respirators; mini-mum requirements.

84.155 Airflow resistance test; Type C sup-plied-air respirator, continuous flowclass and Type CE supplied-air res-pirator; minimum requirements.

84.156 Airflow resistance test; Type C sup-plied-air respirator, demand class; mini-mum requirements.

84.157 Airflow resistance test; Type C sup-plied-air respirator, pressure-demandclass; minimum requirements.

84.158 Exhalation valve leakage test.84.159 Man tests for gases and vapors; sup-

plied-air respirators; general perform-ance requirements.

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528

42 CFR Ch. I (10–1–97 Edition)Pt. 84

84.160 Man tests for gases and vapors; TypeA and Type AE respirators; test require-ments.

84.161 Man tests for gases and vapors; TypeB and Type BE respirators; test require-ments.

84.162 Man test for gases and vapors; Type Crespirators, continuous-flow class andType CE supplied-air respirators; test re-quirements.

84.163 Man test for gases and vapors; Type Csupplied-air respirators, demand andpressure-demand classes; test require-ments.

Tables to Subpart J of Part 84

Subpart K—Non-Powered Air-PurifyingParticulate Respirators

84.170 Non-powered air-purifying particu-late respirators; description.

84.171 Non-powered air-purifying particu-late respirators; required components.

84.172 Breathing tubes; minimum require-ments.

84.173 Harnesses; installation and construc-tion; minimum requirements.

84.174 Respirator containers; minimum re-quirements.

84.175 Half-mask facepieces, full facepieces,hoods, helmets, and mouthpieces; fit;minimum requirements.

84.176 Facepieces, hoods, and helmets; eye-pieces; minimum requirements.

84.177 Inhalation and exhalation valves;minimum requirements.

84.178 Head harnesses; minimum require-ments.

84.179 Non-powered air-purifying particu-late respirators; filter identification.

84.180 Airflow resistance tests.84.181 Non-powered air-purifying particu-

late filter efficiency level determination.84.182 Exhalation valve leakage test; mini-

mum requirements.

Subpart L—Chemical Cartridge Respirators

84.190 Chemical cartridge respirators; de-scription.

84.191 Chemical cartridge respirators; re-quired components.

84.192 Cartridges in parallel; resistance re-quirements.

84.193 Cartridges; color and markings; re-quirements.

84.194 Filters used with chemical cartridges;location; replacement.

84.195 Breathing tubes; minimum require-ments.

84.196 Harnesses; installation and construc-tion; minimum requirements.

84.197 Respirator containers; minimum re-quirements.

84.198 Half-mask facepieces, full facepieces,mouthpieces, hoods, and helmets; fit;minimum requirements.

84.199 Facepieces, hoods, and helmets; eye-pieces; minimum requirements.

84.200 Inhalation and exhalation valves;minimum requirements.

84.201 Head harnesses; minimum require-ments.

84.202 Air velocity and noise levels; hoodsand helmets; minimum requirements.

84.203 Breathing resistance test; minimumrequirements.

84.204 Exhalation valve leakage test; mini-mum requirements.

84.205 Facepiece test; minimum require-ments.

84.206 Particulate tests; respirators with fil-ters; minimum requirements; general.

84.207 Bench tests; gas and vapor tests; min-imum requirements; general.

Tables to Subpart L of Part 84

Subpart M [Reserved]

Subpart N—Special Use Respirators

84.250 Vinyl chloride respirators; descrip-tion.

84.251 Required components.84.252 Gas masks; requirements and tests.84.253 Chemical-cartridge respirators; re-

quirements and tests.84.254 Powered air-purifying respirators; re-

quirements and tests.84.255 Requirements for end-of-service-life

indicator.84.256 Quality control requirements.84.257 Labeling requirements.84.258 Fees.

Subparts O through JJ [Reserved]

Subpart KK—Dust, Fume, and Mist; Pes-ticide; Paint Spray; Powered Air-Purify-ing High Efficiency Respirators andCombination Gas Masks

84.1100 Scope and effective dates.84.1101 Definitions.84.1102 Examination, inspection and testing

of complete respirator assemblies; fees.84.1103 Approval labels and markings; ap-

proval of contents; use.84.1130 Respirators; description.84.1131 Respirators; required components.84.1132 Breathing tubes; minimum require-

ments.84.1133 Harnesses; installation and con-

struction; minimum requirements.84.1134 Respirator containers; minimum re-

quirements.84.1135 Half-mask facepieces, full facepieces,

hoods, helmets, and mouthpieces; fit;minimum requirements.

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529

Public Health Service, HHS § 84.2

84.1136 Facepieces, hoods, and helmets; eye-pieces; minimum requirements.

84.1137 Inhalation and exhalation valves;minimum requirements.

84.1138 Head harnesses; minimum require-ments.

84.1139 Air velocity and noise levels; hoodsand helmets; minimum requirements.

84.1140 Dust, fume, and mist respirators;performance requirements; general.

84.1141 Isoamyl acetate tightness test; dust,fume, and mist respirators designed forrespiratory protection against fumes ofvarious metals having an air contamina-tion level not less than 0.05 milligramper cubic meter; minimum requirements.

84.1142 Isoamyl acetate tightness test; res-pirators designed for respiratory protec-tion against dusts, fumes, and mists hav-ing an air contamination level less than0.05 milligram per cubic meter, oragainst radionuclides; minimum require-ments.

84.1143 Dust, fume, and mist air-purifyingfilter tests; performance requirements;general.

84.1144 Silica dust test for dust, fume, andmist respirators; single-use or reusablefilters; minimum requirements.

84.1145 Silica dust test; non-powered single-use dust respirators; minimum require-ments.

84.1146 Lead fume test for dust, fume, andmist respirators; minimum require-ments.

84.1147 Silica mist test for dust, fume, andmist respirators; minimum require-ments.

84.1148 Tests for respirators designed forrespiratory protection against more thanone type of dispersoid; minimum require-ments.

84.1149 Airflow resistance tests; all dust,fume, and mist respirators; minimum re-quirements.

84.1150 Exhalation valve leakage test; mini-mum requirements.

84.1151 DOP filter test; respirators designedas respiratory protection against dusts,fumes, and mists having an air contami-nation level less than 0.05 milligram percubic meter and against radionuclides;minimum requirements.

84.1152 Silica dust loading test; respiratorsdesigned as protection against dusts,fumes, and mists having an air contami-nation level less than 0.05 milligram percubic meter and against radionuclides;minimum requirements.

84.1153 Dust, fume, mist, and smoke tests;canister bench tests; gas mask canisterscontaining filters; minimum require-ments.

84.1154 Canister and cartridge requirements.84.1155 Filters used with canisters and car-

tridges; location; replacement.

84.1156 Pesticide respirators; performancerequirements; general.

84.1157 Chemical cartridge respirators withparticulate filters; performance require-ments; general.

84.1158 Dust, fume, and mist tests; res-pirators with filters; minimum require-ments; general.

Tables to Subpart KK of Part 84

AUTHORITY: 29 U.S.C. 577a, 651 et seq., and657(g); 30 U.S.C. 3, 5, 7, 811, 842(h), 844.

SOURCE: 60 FR 30355, June 8, 1995, unlessotherwise noted.

Subpart A—General Provisions

§ 84.1 Purpose.

The purpose of the regulations con-tained in this part 84 is:

(a) To establish procedures and pre-scribe requirements which must be metin filing applications for approval bythe National Institute for OccupationalSafety and Health of respirators orchanges or modifications of approvedrespirators;

(b) To establish a schedule of fees tobe charged each applicant for the in-spections, examinations, and testingconducted by the Institute under theprovisions of this part;

(c) To provide for the issuance of cer-tificates of approval or modificationsof certificates of approval for res-pirators which have met the applicableconstruction, performance, and res-piratory protection requirements setforth in this part; and

(d) To specify minimum require-ments and to prescribe methods to beemployed by the Institute and by theapplicant in conducting inspections,examinations, and tests to determinethe effectiveness of respirators usedduring entry into or escape from haz-ardous atmospheres.

§ 84.2 Definitions.

As used in this part—(a) Applicant means an individual,

partnership, company, corporation, as-sociation, or other organization thatdesigns, manufactures, assembles, orcontrols the assembly of a respiratorand who seeks to obtain a certificate ofapproval for such respirator.

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42 CFR Ch. I (10–1–97 Edition)§ 84.2

(b) Approval means a certificate orformal document issued by the Insti-tute stating that an individual res-pirator or combination of respiratorshas met the minimum requirements ofthis part, and that the applicant is au-thorized to use and attach an approvallabel to any respirator, respirator con-tainer, or instruction card for any res-pirator manufactured or assembled inconformance with the plans and speci-fications upon which the approval wasbased, as evidence of such approval.

(c) Approved means conforming to theminimum requirements of this part.

(d) Auxiliary equipment means a self-contained breathing apparatus, the useof which is limited in undergroundmine rescue and recovery operations tosituations where the wearer has readyaccess to fresh air and at least onecrew equipped with approved self-con-tained breathing apparatus of 2 hoursor longer rating, is in reserve at afresh-air base.

(e) Certification and Quality AssuranceBranch means the Certification andQuality Assurance Branch, Division ofSafety Research, Appalachian Labora-tory for Occupational Safety andHealth, National Institute for Occupa-tional Safety and Health, 1095Willowdale Road, Morgantown, WestVirginia 26505–2888.

(f) Compressed-breathing gas means ox-ygen or air stored in a compressedstate and supplied to the wearer in gas-eous form.

(g) dBA means sound pressure levelsin decibels, as measured with the A-weighted network of a standard soundlevel meter using slow response.

(h) Dust means a solid mechanicallyproduced particle with a size rangingfrom submicroscopic to macroscopic.

(i) Respirators for entry into and escapefrom means respiratory devices provid-ing protection during entry into andescape from hazardous atmospheres.

(j) Respirators for escape only meansrespiratory devices providing protec-tion only during escape from hazardousatmospheres.

(k) A facepiece or mouthpiece is a res-pirator component designed to providea gas-tight or dust-tight fit with theface and may include headbands,valves, and connections for canisters,

cartridges, filters, or respirable gassource.

(l) Final inspection means that activ-ity carried out on a product after allmanufacturing and assembly oper-ations are completed to insure com-pleteness and adherence to perform-ance or other specifications, includingsatisfactory appearance.

(m) Fume means a solid condensationparticle, generally less than 1 microm-eter in diameter.

(n) Gas means an aeriform fluidwhich is in a gaseous state at ordinarytemperature and pressure.

(o) Hazardous atmosphere means:(1) Any atmosphere containing a

toxic or disease producing gas, vapor,dust, fume, mist, or pesticide, eitherimmediately or not immediately dan-gerous to life or health; or

(2) Any oxygen-deficient atmosphere.(p) A hood or helmet is a respirator

component which covers the wearer’shead and neck, or head, neck, andshoulders, and is supplied with incom-ing respirable air for the wearer tobreathe. It may include a headharnessand connection for a breathing tube.

(q) Immediately dangerous to life orhealth means conditions that pose animmediate threat to life or health orconditions that pose an immediatethreat of severe exposure to contami-nants, such as radioactive materials,which are likely to have adverse cumu-lative or delayed effects on health.

(r) Incoming inspection means the ac-tivity of receiving, examining, and ac-cepting only those materials and partswhose quality conforms to specifica-tion requirements.

(s) In-process inspection means thecontrol of products at the source ofproduction and at each step of themanufacturing process, so that depar-tures from specifications can be cor-rected before defective components ormaterials are assembled into the fin-ished product.

(t) Institute means the National Insti-tute for Occupational Safety andHealth, Department of Health andHuman Services.

(u) Liquefied-breathing gas means oxy-gen or air stored in liquid form andsupplied to the wearer in a gaseousform.

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531

Public Health Service, HHS § 84.11

(v) Mist means a liquid condensationparticle with a size ranging from sub-microscopic to macroscopic.

(w) MSHA means the Mine Safety andHealth Administration, U.S. Depart-ment of Labor.

(x) Not immediately dangerous to life orhealth means any hazardous atmos-phere which may produce physical dis-comfort immediately, chronic poison-ing after repeated exposure, or acuteadverse physiological symptoms afterprolonged exposure.

(y) Oxygen-deficient atmosphere meansan atmosphere which contains an oxy-gen partial pressure of less than 148millimeters of mercury (19.5 percent byvolume at sea level).

(z) Powered air-purifying respiratormeans a device equipped with a face-piece, hood, or helmet, breathing tube,canister, cartridge, filter, canister withfilter, or cartridge with filter, and ablower.

(aa) Respirator means any device de-signed to provide the wearer with res-piratory protection against inhalationof a hazardous atmosphere.

(bb) Single-use respirator means a res-pirator that is entirely discarded afterexcessive resistance, sorbent exhaus-tion, or physical damage renders it un-suitable for further use.

(cc) Vapor means the gaseous state ofa substance that is solid or liquid at or-dinary temperature and pressure.

§ 84.3 Respirators for mine rescue orother emergency use in mines.

(a)(1) NIOSH and the Mine Safety andHealth Administration (MSHA), U.S.Department of Labor, shall jointly re-view and issue certifications for res-pirators used for mine emergencies andmine rescue, including any associatedservice-life plans, users’ manuals andother supporting documentation.

(2) Each certification for a respiratordesigned for mine rescue or otheremergency use in mines shall include,as a condition of approval, any use lim-itations related to mine safety andhealth.

(b) NIOSH and MSHA shall jointlydetermine appropriate recall and retro-fit remedies for field complaints oridentified deficiencies involving anyrespirators used in the mining environ-ment.

Subpart B—Application forApproval

§ 84.10 Application procedures.(a) Inspection, examination, and test-

ing leading to the approval of the typesof respirators classified in subpart F ofthis part shall be undertaken by the In-stitute only pursuant to written appli-cations which meet the minimum re-quirements set forth in this subpart B.

(b) Applications shall be submitted tothe Certification and Quality Assur-ance Branch, and shall be accompaniedby a check, bank draft, or money orderin the amount specified in subpart C ofthis part, payable to the order of theNational Institute for OccupationalSafety and Health.

(c) Except as provided in § 84.64, theexamination, inspection, and testing ofall respirators shall be conducted bythe Certification and Quality Assur-ance Branch.

(d) Applicants, manufacturers, ortheir representatives may visit or com-municate with the Certification andQuality Assurance Branch in order todiscuss the requirements for approvalof any respirator or the proposed de-signs thereof. No charge shall be madefor such consultation and no writtenreport shall be issued to applicants,manufacturers, or their representativesby the Institute as a result of such con-sultation.

(e) Respirators having electrical orelectronic components that are re-quired to be permissible under chapterI of title 30 shall be tested in accord-ance with 30 CFR part 18. Applicationsfor approval of such respirators byMSHA shall be submitted in writing to:MSHA, Approval and Certification Cen-ter, Box 251, Industrial Park Road,Triadelphia, West Virginia 26059.

§ 84.11 Contents of application.(a) Each application for approval

shall contain a complete written de-scription of the respirator for whichapproval is requested together withdrawings and specifications (and liststhereof) showing full details of con-struction of the respirator and of thematerials used.

(b) Drawings shall be titled, num-bered, and dated; any revision datesshall be shown on the drawings, and

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42 CFR Ch. I (10–1–97 Edition)§ 84.12

the purpose of each revision beingsought shall be shown on the drawingor described on an attachment to thedrawing to which it applies.

(c) Each application for approvalshall contain a proposed plan for qual-ity control which meets the minimumrequirements set forth in subpart E ofthis part.

(d) Each application shall contain astatement that the respirator has beenpretested by the applicant as pre-scribed in § 84.64, and shall include theresults of such tests.

(e) Each application for approvalshall contain a statement that the res-pirator and component parts submittedfor approval are either prototypes, ormade on regular production tooling,with no operation included which willnot be incorporated in regular produc-tion processing.

(The information collections contained inthis section are approved under OMB controlnumber 0920–0109)

§ 84.12 Delivery of respirators andcomponents by applicant; require-ments.

(a) Each applicant shall, when an ap-plication is filed pursuant to § 84.10, beadvised by the Institute of the totalnumber of respirators and componentparts required for testing.

(b) The applicant shall deliver, at hisown expense, the number of completelyassembled respirators and componentparts required for testing, to the Cer-tification and Quality AssuranceBranch.

(c) Respirators and component partssubmitted for approval must be madefrom materials specified in the applica-tion.

(d) One completely assembled res-pirator approved under the provisionsof this part may be retained by the In-stitute as a laboratory exhibit, the re-maining respirators may be returned tothe applicant at his own expense, uponwritten request within 30 days after no-tice of approval. If no such request ismade, the respirators will be disposedof by the Institute in such manner as itdeems appropriate.

(e) Where a respirator fails to meetthe requirements for approval set forthin this part, all respirators and compo-nents delivered in accordance with this

section may be returned to the appli-cant at his own expense, upon writtenrequest within 30 days after notice ofdisapproval. If no such request is made,the respirators will be disposed of bythe Institute in such manner as itdeems appropriate.

Subpart C—Fees§ 84.20 Examination, inspection, and

testing of complete respirator as-semblies; fees.

Except as provided in § 84.22, the fol-lowing fees shall be charged by the In-stitute for the examination, inspectionand testing of complete respirator as-semblies:Self-contained breathing apparatus:

Entry and escape, 1 hour or more ... $3,500Entry and escape, less than 1 hour 2,750Escape only .................................... 2,000

Gas masks:Single hazard .................................. 1,100Type N ............................................ 4,100

Supplied-air respirators .................... 750Particulate respirators ...................... 1,250Chemical cartridge respirators ......... 1,150

§ 84.21 Examination, inspection, andtesting of respirator components orsubassemblies; fees.

Except as provided in § 84.22, the fol-lowing fees shall be charged by the In-stitute for the examination, inspectionand testing of the individual respiratorcomponents or subassemblies:Facepieces ............................................ $450Canisters .............................................. 900Cartridges ............................................. 600Filters .................................................. 650Hoses .................................................... 250Blowers ................................................. 250Harnesses .............................................. 100

§ 84.22 Unlisted fees; additional fees;payment by applicant prior to ap-proval.

(a) Applications for the examination,inspection and testing of complete res-pirator assemblies which are not listedin § 84.20, or for the examination, in-spection, and testing of respirator com-ponents or subassemblies which are notlisted in § 84.21, shall be accompaniedby the following deposits:Complete respirator assembly ........... $1,500Each individual component or sub-

assembly ......................................... 500

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(b) The Institute reserves the right toconduct any examination, inspection,or test it deems necessary to determinethe quality and effectiveness of anylisted or unlisted respirator assemblyor respirator component or subassem-bly, and to assess the cost of such ex-aminations, inspections, or testsagainst the applicant prior to the issu-ance of any approval for such assem-bly, component, or subassembly.

(c) The fees charged for the examina-tion, inspection, and testing of unlistedrespirator assemblies, unlisted individ-ual respirator components or sub-assemblies, and for the additional ex-amination, inspection, and testing oflisted respirator assemblies and compo-nents or subassemblies shall be at therate of $100 per day for each man-dayrequired to be expended by the Insti-tute.

(d) Upon completion of all examina-tions, inspections, and tests of unlistedrespirator assemblies or components,or following the completion of any ad-ditional examination, inspections, ortests of listed assemblies, or compo-nents or subassemblies, including re-testing subsequent to disapproval, theInstitute shall advise the applicant inwriting of the total cost assessed andthe additional amount, if any, whichmust be paid to the Institute as a con-dition of approval.

(e) In the event the amount assessedby the Institute for unlisted assem-blies, or components or subassembliesis less than the amount of the depositsubmitted in accordance with para-graph (a) of this section, the Instituteshall refund the overpayment upon theissuance of any approval or notice ofdisapproval.

Subpart D—Approval andDisapproval

§ 84.30 Certificates of approval; scopeof approval.

(a) The Institute shall issue certifi-cates of approval pursuant to the pro-visions of this subpart only for individ-ual, completely assembled respiratorswhich have been examined, inspected,and tested, and which meet the mini-mum requirements set forth in sub-parts H through L of this part, as appli-cable.

(b) The Institute will not issue cer-tificates of approval for any respiratorcomponent or for any respirator sub-assembly.

(c) The Institute shall not issue aninformal notification of approval. How-ever, if the application for approval,submitted in accordance with § 84.11,states that the submitted respiratorand component parts are only proto-types, the Institute will examine, in-spect, and test such respirator andcomponent parts in accordance withthe provisions of this part. If, uponcompletion of such examinations, in-spections and tests, it is found that theprototype meets the minimum require-ments set forth in this part, the Insti-tute may inform the applicant, in writ-ing, of the results of the examinations,inspections, and tests, and may requirehim to resubmit respirators and com-ponent parts made on regular produc-tion tooling, with no operations in-cluded which will not be incorporatedin regular production processing, forfurther examination, inspection, andtesting, prior to issuance of the certifi-cate of approval.

(d) Applicants required to resubmitrespirators and component parts madeon regular production tooling, with nooperation included which will not beincorporated in regular productionprocessing, shall be charged fees in ac-cordance with subpart C of this part.

§ 84.31 Certificates of approval; con-tents.

(a) The certificate of approval shallcontain a classification and a descrip-tion of the respirator or combination ofrespirators for which it is issued, asprovided in this part.

(b) The certificate of approval shallspecifically set forth any restrictionsor limitations on the respirator’s usein hazardous atmospheres.

(c) Each certificate of approval shallbe accompanied by the drawings andspecifications (and lists thereof) sub-mitted by the applicant in accordancewith § 84.11. These drawings and speci-fications shall be referenced in the cer-tificate of approval, and shall be main-tained by the applicant. The drawings

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and specifications listed in each certifi-cate of approval shall set forth in de-tail the design and construction re-quirements which shall be met by theapplicant during commercial produc-tion of the respirator.

(d) Each certificate of approval shallbe accompanied by a reproduction ofthe approval label design to be em-ployed by the applicant with each ap-proved respirator, as provided in § 84.33.

(e) No test data or specific laboratoryfindings will accompany any certifi-cate of approval, however, the Institutewill release pertinent test data andspecific findings upon written requestby the applicant, or as required bystatute or regulation.

(f) Each certificate of approval shallalso contain the approved quality con-trol plan as specified in § 84.42.

§ 84.32 Notice of disapproval.(a) If, upon the completion of the ex-

aminations, inspections, and tests re-quired to be conducted in accordancewith the provisions of this part, it isfound that the respirator does not meetthe minimum requirements set forth inthis part, the Institute shall issue awritten notice of disapproval to the ap-plicant.

(b) Each notice of disapproval shallbe accompanied by all pertinent dataor findings with respect to the defectsof the respirator for which approvalwas sought with a view to the possiblecorrection of any such defects.

(c) The Institute shall not disclose,except to the applicant or as requiredby statute or regulation, any data,

findings, or other information with re-spect to any respirator for which a no-tice of disapproval is issued.

§ 84.33 Approval labels and markings;approval of contents; use.

(a) Full-scale reproductions of ap-proval labels and markings, and asketch or description of the method ofapplication and position on the har-ness, container, canister, cartridge, fil-ter, or other component, together withinstructions for the use and mainte-nance of the respirator shall be submit-ted to the Institute for approval.

(b) Approval labels shall bear the em-blem of the National Institute for Oc-cupational Safety and Health and theseal of the Department of Health andHuman Services, the applicant’s nameand address, an approval number as-signed by the Institute and, where ap-propriate, restrictions or limitationsplaced upon the use of the respiratorby the Institute. The approval numberassigned by the Institute shall be des-ignated by the prefix TC and a serialnumber.

(c) The Institute shall, where nec-essary, notify the applicant when addi-tional labels, markings, or instructionswill be required.

(d) Approval labels and markingsshall only be used by the applicant towhom they were issued.

(e) Legible reproductions or abbre-viated forms of the label approved bythe Institute for use on each respiratorshall be attached to or printed at thefollowing locations:

Respirator type Label type Location

Self-contained breathing appa-ratus.

Entire ....................................... Harness assembly and canister (where applicable).

Gas mask ................................. Entire ....................................... Mask container and canister.Supplied air respirator .............. ......do ...................................... Respirator container or instruction card.Particulate respirator ................ ......do ...................................... Respirator container and filter container.

Abbreviated ............................. Filters.Chemical-cartridge respirator ... Entire ....................................... Respirator container, cartridge container, and filter containers

(where applicable).Abbreviated ............................. Cartridges and filters and filter containers.

(f) The use of any Institute approvallabel obligates the applicant to whomit is issued to maintain or cause to bemaintained the approved quality con-trol sampling schedule and the accept-able quality level for each characteris-

tic tested, and to assure that it is man-ufactured according to the drawingsand specifications upon which the cer-tificate of approval is based.

(g) Each respirator, respirator com-ponent, and respirator container shall,

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Public Health Service, HHS § 84.41

as required by the Institute to assurequality control and proper use of therespirator, be labeled distinctly toshow the name of the applicant, andthe name and letters or numbers bywhich the respirator or respirator com-ponent is designated for trade pur-poses, and the lot number, serial num-ber, or approximate date of manufac-ture.

§ 84.34 Revocation of certificates of ap-proval.

The Institute reserves the right torevoke, for cause, any certificate of ap-proval issued pursuant to the provi-sions of this part. Such causes include,but are not limited to, misuse of ap-proval labels and markings, misleadingadvertising, and failure to maintain orcause to be maintained the qualitycontrol requirements of the certificateof approval.

§ 84.35 Changes or modifications of ap-proved respirators; issuance ofmodification of certificate of ap-proval.

(a) Each applicant may, if he desiresto change any feature of an approvedrespirator, request a modification ofthe original certificate of approval is-sued by the Institute for such res-pirator by filing an application forsuch modification in accordance withthe provisions of this section.

(b) Applications shall be submitted asfor an original certificate of approval,with a request for a modification of theexisting certificate to cover any pro-posed change.

(c) The application shall be accom-panied by appropriate drawings andspecifications, and by a proposed qual-ity control plan which meets the re-quirements of subpart E of this part.

(d) The application for modification,together with the accompanying mate-rial, shall be examined by the Instituteto determine whether testing will berequired.

(e) The Institute shall inform the ap-plicant of the fee required for any addi-tional testing and the applicant will becharged for the actual cost of any ex-amination, inspection, or test required,and such fees shall be submitted in ac-cordance with the provisions of subpartC of this part.

(f) If the proposed change or modi-fication meets the requirements of thispart, a formal certificate of modifica-tion will be issued, accompanied, wherenecessary, by a list of new and reviseddrawings and specifications coveringthe change(s) and reproductions of re-vised approval labels.

(The information collections contained inthis section are approved under OMB controlnumber 0920–0109)

§ 84.36 Delivery of changed or modi-fied approved respirator.

An approved respirator for which aformal certificate of modification hasbeen issued shall be delivered, withproper markings and containers, by theapplicant to the Certification andQuality Assurance Branch, as soon asit is commercially produced.

Subpart E—Quality Control

§ 84.40 Quality control plans; filing re-quirements.

As a part of each application for ap-proval or modification of approval sub-mitted pursuant to this part, each ap-plicant shall file with the Institute aproposed quality control plan whichshall be designed to assure the qualityof respiratory protection provided bythe respirator for which approval issought.

§ 84.41 Quality control plans; contents.

(a) Each quality control plan shallcontain provisions for the managementof quality, including:

(1) Requirements for the productionof quality data and the use of qualitycontrol records;

(2) Control of engineering drawings,documentations, and changes;

(3) Control and calibration of measur-ing and test equipment;

(4) Control of purchased material toinclude incoming inspection;

(5) Lot identification, control ofprocesses, manufacturing, fabrication,and assembly work conducted in theapplicant’s plant;

(6) Audit of final inspection of thecompleted product; and

(7) The organizational structure nec-essary to carry out these provisions.

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42 CFR Ch. I (10–1–97 Edition)§ 84.41

(b) Each provision for incoming andfinal inspection in the quality controlplan shall include a procedure for theselection of a sample of respirators andthe components thereof for testing, inaccordance with procedures set forth inMilitary Standard MIL–STD–414, 11June 1957, including Change Notice No.1, ‘‘Sampling Procedures and Tables forInspection by Variables for Percent De-fective,’’ or an approved equivalentsampling procedure, or an approvedcombination of sampling procedures.The procedure of Military StandardMIL–STD–105D, 29 April 1963, ‘‘Sam-pling Procedures and Tables for Inspec-tion by Attributes,’’ is an example ofan equivalent sampling procedure.MIL–STD–414 is incorporated by ref-erence and has been approved by theDirector of the Federal Register in ac-cordance with 5 U.S.C. 552(a) and 1 CFRpart 51. Copies may be obtained fromDODSSP, Standardization DocumentOrder Desk, 700 Robbins Avenue, Bldg.4D, Philadelphia, PA 19111–5094. Copiesmay be inspected at the NIOSH, Cer-tification and Quality AssuranceBranch, 1095 Willowdale Road, Morgan-town, WV 26505–2888, or at the Office ofthe Federal Register, 800 North CapitolStreet NW., suite 700, Washington, DC.Copies of MIL–STD–105D may be in-spected or obtained from the NIOSH,Certification and Quality AssuranceBranch, 1095 Willowdale Road, Morgan-town, WV 26505–2888. Incoming bulkraw material inspection or verificationof specification, and in-process inspec-tion shall be sufficient to ensure con-trol of product quality through themanufacturing cycle.

(c) The sampling procedure shall in-clude a list of the characteristics to betested by the applicant or his agent.

(d) The characteristics listed in ac-cordance with paragraph (c) of this sec-tion shall be classified according to thepotential effect of such defect andgrouped into the following classes:

(1) Critical. A defect that judgmentand experience indicate is likely to re-sult in a condition immediately haz-ardous to life or health for individualsusing or depending upon the respirator;

(2) Major A. A defect, other than crit-ical, that is likely to result in failureto the degree that the respirator doesnot provide any respiratory protection,

or a defect that reduces protection andis not detectable by the user;

(3) Major B. A defect, other thanMajor A or critical, that is likely to re-sult in reduced respiratory protection,and is detectable by the user; and

(4) Minor. A defect that is not likelyto materially reduce the usability ofthe respirator for its intended purpose,or a defect that is a departure from es-tablished standards and has little bear-ing on the effective use or operation ofthe respirator.

(e) The quality control inspectiontest method to be used by the applicantor his agent for each characteristic re-quired to be tested shall be described indetail.

(f) Each item manufactured shall be100 percent inspected for defects in allcritical characteristics and all defec-tive items shall be rejected.

(g) The Acceptable Quality Level(AQL) for each major or minor defectso classified by the applicant shall be:

(1) Major A. 1.0 percent;(2) Major B. 2.5 percent; and(3) Minor. 4.0 percent.(h) Except as provided in paragraph

(i) of this section, inspection level IVas described in MIL–STD–414, 11 June1957, including Change Notice No.1,‘‘Sampling Procedures and Tables forInspection by Variables for Percent De-fective,’’ or an equivalent procedure,shall be used for major and minor char-acteristics and 100 percent inspectionfor critical characteristics. Inspectionlevel II as described in MIL–STD–105D,29 April 1963, ‘‘Sampling Proceduresand Tables for Inspection by At-tributes,’’ is an example of an equiva-lent procedure.

(i) Subject to the approval of the In-stitute, where the quality control planprovisions for raw material, processes,manufacturing, and fabrication, in-spections are adequate to ensure con-trol of finished article quality, destruc-tive testing of finished articles may beconducted at a lower level of inspec-tion than that specified in paragraph(h) of this section.

(The information collections contained inthis section are approved under OMB controlnumber 0920–0109)

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Public Health Service, HHS § 84.52

§ 84.42 Proposed quality control plans;approval by the Institute.

(a) Each proposed quality controlplan submitted in accordance with thissubpart shall be reviewed by the Insti-tute to determine its effectiveness inensuring the quality of respiratory pro-tection provided by the respirator forwhich an approval is sought.

(b) If the Institute determines thatthe proposed quality control plan sub-mitted by the applicant will not ensureadequate quality control, the Instituteshall require the applicant to modifythe procedures and testing require-ments of the plan prior to approval ofthe plan and issuance of any certificateof approval.

(c) Approved quality control plansshall constitute a part of and be incor-porated into any certificate of approvalissued by the Institute, and compliancewith such plans by the applicant shallbe a condition of approval.

§ 84.43 Quality control records; reviewby the Institute; revocation of ap-proval.

(a) The applicant shall keep qualitycontrol inspection records sufficient tocarry out the procedures required inMIL–STD–414, 11 June 1957, includingChange Notice No. 1, ‘‘Sampling Proce-dures and Tables for Inspection byVariables for Percent Defective,’’ or anapproved equivalent sampling proce-dure. MIL–STD–105D, 29 April 1963,‘‘Sampling Procedures and Tables forInspection by Attributes,’’ is an exam-ple of an approved equivalent samplingprocedure. MIL–STD–414 is incor-porated by reference and has been ap-proved by the Director of the FederalRegister in accordance with 5 U.S.C.552(a) and 1 CFR part 51. Copies may beobtained from DODSSP, Standardiza-tion Document Order Desk, 700 RobbinsAvenue, Bldg. 4D, Philadelphia, Pa.19111–5094. Copies may be inspected atthe NIOSH, Certification and QualityAssurance Branch, 1095 WillowdaleRoad, Morgantown, WV 26505–2888, orat the Office of the Federal Register,800 North Capitol Street, NW., suite700, Washington, DC. Copies of MIL–STD–105D may be inspected or obtainedfrom the NIOSH, Certification andQuality Assurance Branch, 1095

Willowdale Road, Morgantown, WV26505–2888.

(b) The Institute reserves the right tohave its representatives inspect the ap-plicant’s quality control test methods,equipment, and records, and to inter-view any employee or agent of the ap-plicant in regard to quality controltest methods, equipment, and records.

(c) The Institute reserves the right torevoke, for cause, any certificate of ap-proval where it is found that the appli-cant’s quality control test methods,equipment, or records do not ensure ef-fective quality control over the res-pirator for which the approval was is-sued.

(The information collections contained inthis section are approved under OMB controlnumber 0920–0109)

Subpart F—Classification of Ap-proved Respirators; Scope ofApproval; Atmospheric Haz-ards; Service Time

§ 84.50 Types of respirators to be ap-proved; scope of approval.

Approvals shall be issued for thetypes of respirators which have beenclassified pursuant to this subpart F,have been inspected, examined andtested by the Institute, in accordancewith the provisions of subparts Gthrough L of this part, and have beenfound to provide respiratory protectionfor fixed periods of time against thehazards specified in such approval.

§ 84.51 Entry and escape, or escapeonly; classification.

Respirators described in subparts Hthrough L of this part shall be classi-fied for use as follows:

(a) Entry and escape. Respirators de-signed and approved for use duringentry into a hazardous atmosphere,and for escape from a hazardous atmos-phere; or

(b) Escape only. Respirators designedand approved for use only during es-cape from a hazardous atmosphere.

§ 84.52 Respiratory hazards; classifica-tion.

Respirators described in subparts Hthrough L of this part shall be classi-fied as approved for use against any or

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all of the following respiratory haz-ards:

(a) Oxygen deficiency;(b) Gases and vapors; and(c) Particles, including dusts, fumes

and mists.

§ 84.53 Service time; classification.(a) Respirators described in subparts

H through L of this part shall be classi-fied, where applicable, as approved foruse during the following prescribedservice times:

(1) Four hours;(2) Three hours;(3) Two hours;(4) One hour;(5) Forty-five minutes;(6) Thirty minutes;(7) Fifteen minutes;(8) Ten minutes;(9) Five minutes; or(10) Three minutes.(b) Other service times may be pre-

scribed by the Institute.

Subpart G—General Constructionand Performance Requirements

§ 84.60 Construction and performancerequirements; general.

(a) The Institute shall issue approv-als for the types of respirators de-scribed in subparts H through L of thispart which have met the minimum re-quirements set forth for such res-pirators in this part.

(b) In addition to the types of res-pirators specified in subparts Hthrough L of this part, the Instituteshall issue approvals for other res-piratory protective devices not specifi-cally described in this part subject tosuch additional requirements as maybe imposed in accordance with§ 84.63(c).

§ 84.61 General construction require-ments.

(a) Respirators will not be acceptedby the Institute for examination, in-spection and testing unless they are de-signed on sound engineering and sci-entific principles, constructed of suit-able materials and evidence good work-manship.

(b) Respirator components whichcome into contact with the wearer’s

skin shall be made of nonirritating ma-terials.

(c) Components replaced during orafter use shall be constructed of mate-rials which will not be damaged by nor-mal handling.

(d) Mouthpieces, hoods, helmets, andfacepieces, except those employed insingle-use respirators, shall be con-structed of materials which will with-stand repeated disinfection as rec-ommended by the applicant in his in-structions for use of the device.

§ 84.62 Component parts; minimum re-quirements.

(a) The component parts of each res-pirator shall be:

(1) Designed, constructed, and fittedto insure against creation of any haz-ard to the wearer;

(2) Assembled to permit easy accessfor inspection and repair of functionalparts; and

(3) Assembled to permit easy accessto parts which require periodic clean-ing and disinfecting.

(b) Replacement parts shall be de-signed and constructed to permit easyinstallation and to maintain the effec-tiveness of the respirator.

§ 84.63 Test requirements; general.

(a) Each respirator and respiratorcomponent shall when tested by the ap-plicant and by the Institute, and meetthe applicable requirements set forthin subparts H through L of this part.

(b) Where a combination respirator isassembled from two or more types ofrespirators, as described in this part,each of the individual respirator typeswhich have been combined shall, as ap-plicable, meet the minimum require-ments for such respirators set forth insubparts H through L of this part, andsuch combination respirators, exceptas specified in § 84.70(b)(2), will be clas-sified by the type of respirator in thecombination which provides the leastprotection to the user.

(c) In addition to the minimum re-quirements set forth in subparts Hthrough L of this part, the Institute re-serves the right to require, as a furthercondition of approval, any additionalrequirements deemed necessary to es-tablish the quality, effectiveness, and

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Public Health Service, HHS § 84.66

safety of any respirator used as protec-tion against hazardous atmospheres.

(d) Where it is determined after re-ceipt of an application that additionalrequirements will be required for ap-proval, the Institute will notify the ap-plicant in writing of these additionalrequirements, and necessary examina-tions, inspections, or tests, statinggenerally the reasons for such require-ments, examinations, inspections, ortests.

§ 84.64 Pretesting by applicant; ap-proval of test methods.

(a) Prior to making or filing any ap-plication for approval or modificationof approval, the applicant shall con-duct, or cause to be conducted, exami-nations, inspections, and tests of res-pirator performance which are equal toor exceed the severity of those pre-scribed in this part.

(b) With the application, the appli-cant shall provide a statement to theInstitute showing the types and resultsof the examinations, inspections, andtests required under paragraph (a) ofthis section and state that the res-pirator meets the minimum require-ments of subparts H through L of thispart, as applicable. Complete examina-tion, inspection, and test data shall beretained on file by the applicant and besubmitted, upon request, to the Insti-tute.

(c) The Institute may, upon writtenrequest by the applicant, provide draw-ings and descriptions of its test equip-ment and otherwise assist the appli-cant in establishing a test laboratoryor securing the services of a testingagency.

(d) No approval will be issued untilthe Institute has validated the appli-cant’s test results.

§ 84.65 Conduct of examinations, in-spections, and tests by the Institute;assistance by applicant; observers;recorded data; public demonstra-tions.

(a) All examinations, inspections,and tests conducted pursuant to sub-parts H through L of this part will beunder the sole direction and control ofthe Institute.

(b) The Institute may, as a conditionof approval, require the assistance ofthe applicant or agents of the applicantduring the assembly, disassembly, orpreparation of any respirator or res-pirator component prior to testing orin the operation of such equipmentduring testing.

(c) Only Institute personnel, personsassisting the Institute pursuant toparagraph (b) of this section, and suchother persons as are requested by theInstitute or the applicant to be observ-ers, shall be present during any exam-ination, inspection, or test conductedprior to the issuance of an approval bythe Institute for the equipment underconsideration.

(d) The Institute shall hold as con-fidential any analyses, drawings, speci-fications, or materials submitted bythe applicant and shall not discloseany principles or patentable features ofsuch equipment, except as required bystatute or regulation.

(e) As a condition of each approval is-sued for any respirator, the Institutereserves the right, following the issu-ance of such approval, to conduct suchpublic tests and demonstrations of theapproved respiratory equipment as isdeemed appropriate.

§ 84.66 Withdrawal of applications; re-fund of fees.

(a) Any applicant may, upon a writ-ten request submitted to the Institute,withdraw any application for approvalof any respirator.

(b) Upon receipt of a written requestfor the withdrawal of an application,the Institute shall determine the totalman-days expended and the amountdue for services already performed dur-ing the course of any examinations, in-spections, or tests conducted pursuantto such application. The total amountdue shall be determined in accordancewith the provisions of § 84.22 and as-sessed against the fees submitted bythe applicant. If the total amount as-sessed is less than the fees submitted,the Institute shall refund the balancetogether with a statement of thecharges made for services rendered.

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Subpart H—Self-ContainedBreathing Apparatus

§ 84.70 Self-contained breathing appa-ratus; description.

(a) Self-contained breathing appara-tus, including all completely assem-bled, portable, self-contained devicesdesigned for use as respiratory protec-tion during entry into and escape fromor escape only from hazardousatmospheres, are described as follows:

(1) Closed-circuit apparatus. An appa-ratus of the type in which the exhala-tion is rebreathed by the wearer afterthe carbon dioxide has been effectivelyremoved and a suitable oxygen con-centration restored from sources com-posed of:

(i) Compressed oxygen; or(ii) Chemical oxygen; or(iii) Liquid-oxygen.(2) Open-circuit apparatus. An appa-

ratus of the following types from whichexhalation is vented to the atmosphereand not rebreathed:

(i) Demand-type apparatus. An appara-tus in which the pressure inside thefacepiece in relation to the immediateenvironment is positive during exhala-tion and negative during inhalation; or

(ii) Pressure-demand-type apparatus.An apparatus in which the pressure in-side the facepiece in relation to the im-mediate environment is positive duringboth inhalation and exhalation.

(b) The following respirators may beclassified as designed and approved foruse during emergency entry into a haz-ardous atmosphere:

(1) A combination respirator whichincludes a self-contained breathing ap-paratus; and

(2) A Type ‘‘C’’ or Type ‘‘CE’’ sup-plied air respirator, where—

(i) The self-contained breathing appa-ratus is classified for 3-, 5-, or 10-minute service time and the air linesupply is used during entry; or

(ii) The self-contained breathing ap-paratus is classified for 15 minutes orlonger service time and not more than20 percent of the rated capacity of theair supply is used during entry.

(c) Self-contained breathing appara-tus classified for less than 1 hour serv-ice time will not be approved for useduring underground mine rescue and

recovery operations except as auxiliaryequipment.

(d) Self-contained breathing appara-tus classified for less than 30 minutes’service time will not be approved foruse as auxiliary equipment during un-derground mine rescue and recoveryoperations.

§ 84.71 Self-contained breathing appa-ratus; required components.

(a) Each self-contained breathing ap-paratus described in § 84.70 shall, whereits design requires, contain the follow-ing component parts:

(1) Facepiece or mouthpiece, andnoseclip;

(2) Respirable breathing gas con-tainer;

(3) Supply of respirable breathinggas;

(4) Gas pressure or liquid level gages;(5) Timer;(6) Remaining service life indicator

or warning device;(7) Hand-operated valves;(8) Breathing bag;(9) Safety relief valve or safety relief

system; and(10) Harness.(b) The components of each self-con-

tained breathing apparatus shall meetthe minimum construction require-ments set forth in subpart G of thispart.

§ 84.72 Breathing tubes; minimum re-quirements.

Flexible breathing tubes used in con-junction with breathing apparatusshall be designed and constructed toprevent:

(a) Restriction of free head move-ment;

(b) Disturbance of the fit offacepieces and mouthpieces;

(c) Interference with the wearer’s ac-tivities; and

(d) Shutoff of airflow due to kinking,or from chin or arm pressure.

§ 84.73 Harnesses; installation and con-struction; minimum requirements.

(a) Each apparatus shall, where nec-essary, be equipped with a suitable har-ness designed and constructed to holdthe components of the apparatus in po-sition against the wearer’s body.

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Public Health Service, HHS § 84.79

(b) Harnesses shall be designed andconstructed to permit easy removaland replacement of apparatus partsand, where applicable, provide for hold-ing a full facepiece in the ready posi-tion when not in use.

§ 84.74 Apparatus containers; mini-mum requirements.

(a) Apparatus may be equipped with asubstantial, durable container bearingmarkings which show the applicant’sname, the type and commercial des-ignation of the respirator it contains,and all appropriate approval labels.

(b) Containers supplied by the appli-cant for carrying or storing self-con-tained breathing apparatus will be in-spected, examined, and tested as com-ponents of the respirator for which ap-proval is sought.

(c) Containers for self-containedbreathing apparatus shall be designedand constructed to permit easy re-moval of the apparatus.

§ 84.75 Half-mask facepieces, fullfacepieces, mouthpieces; fit; mini-mum requirements.

(a) Half-mask facepieces and fullfacepieces shall be designed and con-structed to fit persons with various fa-cial shapes and sizes, either:

(1) By providing more than one face-piece size; or

(2) By providing one facepiece sizewhich will fit varying facial shapes andsizes.

(b) Full facepieces shall provide forthe optional use of corrective spec-tacles or lenses which shall not reducethe respiratory protective qualities ofthe apparatus.

(c) Apparatus with mouthpieces shallbe equipped with noseclips which aresecurely attached to the mouthpiece orapparatus and provide an airtight seal.

(d) Facepieces shall be designed toprevent eyepiece, spectacle, and lensfogging.

§ 84.76 Facepieces; eyepieces; mini-mum requirements.

(a) Facepieces shall be designed andconstructed to provide adequate visionwhich is not distorted by the eyepiece.

(b) All eyepieces shall be designedand constructed to be impact and pene-tration resistant. Federal Specifica-

tion, Mask, Air Line: and Respirator,Air Filtering, Industrial, GGG–M–125d,October 11, 1965 with interim amend-ment-1, July 30, 1969, is an example ofan appropriate standard for determin-ing impact and penetration resistance.Copies of GGG–M–125d may be obtainedfrom the NIOSH, Certification andQuality Assurance Branch, 1095Willowdale Road, Morgantown, WV26505–2888.

§ 84.77 Inhalation and exhalationvalves; minimum requirements.

(a) Inhalation and exhalation valvesshall be provided where necessary andprotected against damage and distor-tion.

(b) Exhalation valves shall be—(1) Protected against external influ-

ence; and(2) Designed and constructed to pre-

vent inward leakage of contaminatedair.

§ 84.78 Head harnesses; minimum re-quirements.

(a) Facepieces shall be equipped withadjustable and replaceable head har-nesses designed and constructed to pro-vide adequate tension during suspen-sion and an even distribution of pres-sure over the entire area in contactwith the face.

(b) Mouthpieces shall be equipped,where applicable, with adjustable andreplaceable harnesses designed andconstructed to hold the mouthpiece inplace.

§ 84.79 Breathing gas; minimum re-quirements.

(a) Breathing gas used to supply ap-paratus shall be respirable and containno less than 19.5 (dry atmosphere) vol-ume percent of oxygen.

(b) Oxygen, including liquid oxygen,shall contain not less than 99.0 percent,by volume, of pure O2, not more than0.03%, by volume, carbon dioxide, andnot more than 0.001%, by volume, car-bon monoxide. Methods for makingthese determinations can be found inthe U.S. Pharmacopeia National For-mulary. Containers used for oxygenmust not be treated with any toxic,sleep-inducing, narcosis-producing, orrespiratory tract irritating compounds.

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42 CFR Ch. I (10–1–97 Edition)§ 84.80

(c) Compressed, gaseous breathing airshall meet the applicable minimumgrade requirements for Type I gaseousair set forth in the Compressed Gas As-sociation Commodity Specification forAir, G–7.1, 1966 (Grade D or higher qual-ity). G–7.1 is incorporated by referenceand has been approved by the Directorof the Federal Register in accordancewith 5 U.S.C. 552(a) and 1 CFR part 51.Copies may be obtained from AmericanNational Standards Institute, Inc., 1430Broadway, New York, NY 10018. Copiesmay be inspected at the NIOSH, Cer-tification and Quality AssuranceBranch, 1095 Willowdale Road, Morgan-town, WV 26505–2888, or at the Office ofthe Federal Register, 800 North CapitolStreet, NW., suite 700, Washington, DC.

(d) Compressed, liquefied breathingair shall meet the applicable minimumgrade requirements for Type II liquidair set forth in the Compressed Gas As-sociation Commodity Specification forAir, G–7.1, 1966 (Grade B or higher qual-ity). G–7.1 is incorporated by referenceand has been approved by the Directorof the Federal Register in accordancewith 5 U.S.C. 552(a) and 1 CFR part 51.Copies may be obtained from AmericanNational Standards Institute, Inc., 1430Broadway, New York, NY 10018. Copiesmay be inspected at the NIOSH, Cer-tification and Quality AssuranceBranch, 1095 Willowdale Road, Morgan-town, WV 26505–2888, or at the Office ofthe Federal Register, 800 North CapitolStreet, NW., suite 700, Washington, DC.

§ 84.80 Interchangeability of oxygenand air prohibited.

Approvals shall not be issued by theInstitute for any apparatus, combina-tion of respirator assemblies, or anyapparatus or respirator componentwhich is designed or constructed topermit the interchangeable use of oxy-gen and air.

§ 84.81 Compressed breathing gas andliquefied breathing gas containers;minimum requirements.

(a) Compressed breathing gas and liq-uefied breathing gas containers shallmeet the minimum requirements of theDepartment of Transportation forinterstate shipment of such containerswhen fully charged.

(b) Such containers shall be perma-nently and legibly marked to identifytheir contents, e.g., compressed breath-ing air, compressed breathing oxygen,liquefied breathing air, or liquefiedbreathing oxygen.

(c) Containers normally removedfrom apparatus for refilling shall beequipped with a dial indicating gagewhich shows the pressure in the con-tainer.

(d) Compressed breathing gas con-tained valves or a separate chargingsystem or adapter provided with eachapparatus shall be equipped with outletthreads specified for the service by theAmerican Standards Association, Com-pressed Gas Cylinder Valve Outlet andInlet Connections, B57.1–1965. B57.1–1965is incorporated by reference and hasbeen approved by the Director of theFederal Register in accordance with 5U.S.C. 552(a) and 1 CFR part 51. Copiesmay be obtained from American Na-tional Standards Institute, Inc., 1430Broadway, New York, NY Copies maybe inspected at the NIOSH, Certifi-cation and Quality Assurance Branch,1095 Willowdale Road, Morgantown, WV26505–2888, or at the Office of the FED-ERAL REGISTER, 800 North CapitolStreet, NW., suite 700, Washington, DC.

§ 84.82 Gas pressure gages; minimumrequirements.

(a) Gas pressure gages employed oncompressed breathing gas containersshall be calibrated in pounds per squareinch.

(b) Liquid-level gages shall be cali-brated in fractions of total containercapacity, or in units of liquid volume.

(c) Gas pressure gages other thanthose specified in paragraphs (a) and(b) of this section shall be calibratedin:

(1) Pounds per square inch; or(2) In fractions of total container ca-

pacity; or(3) Both in pounds per square inch

and fractions of total container capac-ity.

(d)(1) Dial-indicating gages shall bereliable to within ±5 percent of fullscale when tested both up and down thescale at each of 5 equal intervals.

(2) The full-scale graduation of dial-indicating gages shall not exceed 150percent of the maximum rated cylinder

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Public Health Service, HHS § 84.84

pressures specified for the container inapplicable Department of Transpor-tation specifications or permits.

(e)(1) Stem-type gages shall be read-able by sight and by touch and shallhave a stem travel distance of not lessthan one-fourth inch between eachgraduation.

(2) A minimum of five graduationsshall be engraved on the stem of eachgage and these graduations shall in-clude readings for empty, one-quarter,one-half, three-quarters, and full.

(3) Stem gage readings shall not varyfrom true readings by more than one-sixteenth inch per inch of stem travel.

(f) The loss of gas through a brokengage or severed gage connection shallnot exceed 70 liters per minute whenthe cylinder pressure is 6,900 kN/m.2

(1,000 pounds per square inch gage) orwhen the liquid level is at one-half.

(g) Where gages are connected to theapparatus through a gage line, the gageand line shall be capable of being iso-lated from the apparatus except wherethe failure of the gage or line wouldnot impair the performance or servicelife of the apparatus.

(h) Oxygen pressure gages shall havethe words ‘‘Oxygen’’ and ‘‘Use No Oil’’marked prominently on the gage.

(i)(1) Apparatus using compressedbreathing gas, except apparatus classi-fied for escape only, shall be equippedwith gages visible to the wearer whichindicate the remaining gas content inthe container.

(2) Apparatus using liquefied breath-ing gas, except apparatus classified forescape only, shall be equipped withgages visible to the wearer which indi-cate the remaining liquid content inthe container; however, where the liq-uid content cannot be rapidly vented,and the service time of the device be-gins immediately after filling, a timershall be provided in place of a visiblegage.

§ 84.83 Timers; elapsed time indica-tors; remaining service life indica-tors; minimum requirements.

(a) Elapsed time indicators shall beprovided for apparatus with a chemicaloxygen source, except:

(1) Apparatus used for escape only; or(2) Liquefied breathing gas apparatus

equipped with gages visible to the

wearer which indicate the remainingliquid content in the container.

(b) The timer or other indicator shallbe accurately calibrated in minutes ofremaining service life.

(c) Timers shall be readable by sightand by touch during use by the wearer.

(d) Timers shall be equipped withautomatically preset alarms which willwarn the wearer for a period of 7 sec-onds or more after the preset time haselapsed.

(e) Remaining service-life indicatorsor warning devices shall be provided inaddition to a pressure gage on com-pressed gas self-contained breathingapparatus, except apparatus used forescape only, and shall operate auto-matically without preadjustment bythe wearer.

(f) Each remaining service-life indi-cator or warning device shall give analarm when the remaining service lifeof the apparatus is reduced within arange of 20 to 25 percent of its ratedservice time.

§ 84.84 Hand-operated valves; mini-mum requirements.

(a) Hand-operated valves shall be de-signed and constructed to prevent re-moval of the stem from the valve bodyduring normal usage to insure againsta sudden release of the full pressure ofthe container when the valve is opened.

(b) Valves shall be designed or posi-tioned to prevent accidental openingand closing, and damage from externalforces.

(c) Valves operated during use of theapparatus shall be installed in loca-tions where they can be readily ad-justed by the wearer.

(d) Main-line valves, designed andconstructed to conserve gas in theevent of a regulator or demand valvefailure, shall be provided in addition togas container valves, except when suchfailure will not affect performance.

(e) Hand-operated bypass systems de-signed and constructed to permit thewearer to breathe and to conserve hisgas supply in the event of a regulatoror demand valve failure, shall be pro-vided where necessary.

(f) Valves installed on apparatusshall be clearly distinguishable fromone another by sight and touch.

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42 CFR Ch. I (10–1–97 Edition)§ 84.85

(g) The bypass system valve controlshall be colored red.

(h) A main-line or bypass valve orsystem will not be required on appara-tus for escape only.

(i) Safety relief valves or systems,designed and constructed to release ex-cess pressure in the breathing circuit,shall be provided on closed-circuit ap-paratus, and shall meet the followingrequirements:

(1) The relief valve or system shalloperate automatically when the pres-sure in the breathing circuit on the in-halation side of the breathing bagreaches 13 mm. (one-half inch) water-column height of pressure above theminimum pressure required to fill thebreathing bag, within the breathing re-sistance requirements for the appara-tus.

(2) The relief valve or system shall bedesigned to prevent externalatmospheres from entering the breath-ing circuit.

(3) The relief valve or system shall bedesigned to permit manual overridingfor test purposes and in the event of afailure in the valve or system.

§ 84.85 Breathing bags; minimum re-quirements.

(a) Breathing bags shall have suffi-cient volume to prevent gas waste dur-ing exhalation and to provide an ade-quate reserve for inhalation.

(b) Breathing bags shall be con-structed of materials which are flexibleand resistant to gasoline vapors.

(c) Breathing bags shall be installedin a location which will protect themfrom damage or collapse by externalforces, except on apparatus classifiedfor escape only.

§ 84.86 Component parts exposed tooxygen pressures; minimum re-quirements.

Each applicant shall certify that thematerials employed in the construc-tion of component parts exposed to ox-ygen pressures above atmospheric pres-sure are safe and compatible for theirintended use.

§ 84.87 Compressed gas filters; mini-mum requirements.

All self-contained breathing appara-tus using compressed gas shall have a

filter downstream of the gas source toeffectively remove particles from thegas stream.

§ 84.88 Breathing bag test.(a) Breathing bags will be tested in

an air atmosphere saturated with gaso-line vapor at room temperature (24–30°C./75–85 °F.) for a continuous period oftwice the rated time of the apparatus(except for apparatus for escape onlywhere the test period shall be the ratedtime of the apparatus).

(b) The bag will be operated duringthis test by a breathing machine with24 respirations per minute and aminute-volume of 40 liters.

(c) A breathing machine cam with awork rate of 622 kp.-m./min. will beused. The dimensions of a suitablebreathing machine cam are availablefrom the Institute upon request.

(d) The air within the bag(s) shall notcontain more than 100 parts per millionof gasoline vapor at the end of the test.

§ 84.89 Weight requirement.(a) The completely assembled and

fully charged apparatus shall not weighmore than 16 kg. (35 pounds); however,where the weight decreases by morethan 25 percent of its initial chargeweight during its rated service life, themaximum allowable weight of a com-pletely assembled and fully charged ap-paratus shall be 18 kg. (40 pounds).

(b) Where an apparatus employsequipment which contributes materi-ally to the wearer’s comfort, e.g., acooling system, the completely assem-bled and fully charged apparatus shallnot weigh more than 18 kg. (40 pounds)regardless of the decrease in weightduring use.

§ 84.90 Breathing resistance test; inha-lation.

(a) Resistance to inhalation airflowwill be measured in the facepiece ormouthpiece while the apparatus is op-erated by a breathing machine as de-scribed in § 84.88.

(b) The inhalation resistance of open-circuit apparatus shall not exceed 32mm. (1.25 inch) water-column height(at a flow rate of 120 liters per minute).

(c) The inhalation resistance ofclosed-circuit apparatus shall not ex-ceed the difference between exhalation

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545

Public Health Service, HHS § 84.97

resistance (§ 84.91(e)) and 10 cm. (4inches) water-column height.

§ 84.91 Breathing resistance test; exha-lation.

(a) Resistance to exhalation airflowwill be measured in the facepiece ormouthpiece of open-circuit apparatuswith air flowing at a continuous rate of85 liters per minute.

(b) The exhalation resistance of de-mand apparatus shall not exceed 25mm. (1 inch) water-column height.

(c) The exhalation resistance of pres-sure-demand apparatus shall not ex-ceed the static pressure in the face-piece by more than 51 mm. (2 inches)water-column height.

(d) The static pressure (at zero flow)in the facepiece shall not exceed 38mm. (1.5 inches) water-column height.

(e) Resistance to exhalation airflowwill be measured in the facepiece ormouthpiece of closed-circuit apparatuswith a breathing machine as describedin § 84.88, and the exhalation resistanceshall not exceed 51 mm. (2 inches)water-column height.

§ 84.92 Exhalation valve leakage test.

(a) Dry exhalation valves and valveseats will be subjected to a suction of25 mm. (1 inch) water-column heightwhile in a normal operating position.

(b) Leakage between the valve andthe valve seat shall not exceed 30 milli-liters per minute.

§ 84.93 Gas flow test; open-circuit ap-paratus.

(a) A static-flow test will be per-formed on all open-circuit apparatus.

(b) The flow from the apparatus shallbe greater than 200 liters per minutewhen the pressure in the facepiece ofdemand-apparatus is lowered by 51 mm.(2 inches) water-column height whenfull container pressure is applied.

(c) Where pressure demand apparatusare tested, the flow will be measured atzero gage pressure in the facepiece.

(d) Where apparatus with com-pressed-breathing-gas containers aretested, the flow test shall also be madewith 3,450 kN/m.2 (500 p.s.i.g.) containerpressure applied.

§ 84.94 Gas flow test; closed-circuit ap-paratus.

(a) Where oxygen is supplied by aconstant-flow device only, the rate offlow shall be at least 3 liters perminute for the entire rated servicetime of the apparatus.

(b) Where constant flow is used inconjunction with demand flow, the con-stant flow shall be greater than 1.5 li-ters per minute for the entire ratedservice time.

(c) All demand-flow devices shall pro-vide at least 30 liters of oxygen perminute when in the fully open position.

§ 84.95 Service time test; open-circuitapparatus.

(a) Service time will be measuredwith a breathing machine as describedin § 84.88.

(b) The open-circuit apparatus will beclassified according to the length oftime it supplies air or oxygen to thebreathing machine.

(c) The service time obtained on thistest will be used to classify the open-circuit apparatus in accordance with§ 84.53.

§ 84.96 Service time test; closed-circuitapparatus.

(a) The closed-circuit apparatus willbe classified according to the length oftime it supplies adequate breathing gasto the wearer during man test No. 4 de-scribed in Table 4 of this subpart.

(b) The service time obtained on mantest No. 4 will be used to classify theclosed-circuit apparatus in accordancewith § 84.53.

§ 84.97 Test for carbon dioxide in in-spired gas; open- and closed-circuitapparatus; maximum allowable lim-its.

(a) Open-circuit apparatus:(1) The concentration of carbon diox-

ide in inspired gas in open-circuit appa-ratus will be measured at the mouthwhile the apparatus mounted on adummy head is operated by a breathingmachine. An acceptable method formeasuring the concentration of carbondioxide is described in Bureau of MinesReport of Investigations 6865, A Ma-chine-Test Method for Measuring Car-bon Dioxide in the Inspired Air of Self-Contained Breathing Apparatus, 1966.

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42 CFR Ch. I (10–1–97 Edition)§ 84.98

Copies of Report of Investigations 6865may be inspected or obtained from theNIOSH, Certification and Quality As-surance Branch, 1095 Willowdale Road,Morgantown, WV. 26505–2888.

(2) The breathing rate will be 14.5 res-pirations per minute with a minute-volume of 10.5 liters.

(3) A sedentary breathing machinecam will be used.

(4) The apparatus will be tested at atemperature of 27 ± 2° C. (80 ± 5° F.).

(5) A concentration of 5 percent car-bon dioxide in air will be exhaled intothe facepiece.

(b) Closed-circuit apparatus. The con-centration of carbon dioxide in inspiredgas in closed-circuit apparatus will bemeasured at the mouth while the partsof the apparatus contributing to dead-air space are mounted on a dummyhead and operated by the breathingmachine as in paragraphs (a) (1)through (5) of this section.

(c) During the testing required byparagraphs (a) and (b) of this section,the concentration of carbon dioxide ininspired gas at the mouth will be con-tinuously recorded, and the maximumaverage concentration during the inha-lation portion of the breathing cycleshall not exceed the following limits:

Where the service time is

Maximum allowable av-erage concentration ofcarbon dioxide in in-spired air percent by

volume

Not more than 30 minutes ............. 2.51 hour ............................................ 2.02 hours ........................................... 1.53 hours ........................................... 1.04 hours ........................................... 1.0

(d) In addition to the test require-ments for closed-circuit apparatus setforth in paragraph (b) of this section,gas samples will be taken during thecourse of the man tests described inTables 1, 2, 3, and 4 of this subpart.These gas samples will be taken fromthe closed-circuit apparatus at a pointdownstream of the carbon dioxide sor-bent, and they shall not contain morethan 0.5 percent carbon dioxide at anytime, except on apparatus for escapeonly, using a mouthpiece only, thesample shall not contain more than 1.5percent carbon dioxide at any time.

§ 84.98 Tests during low temperatureoperation.

(a) The applicant shall specify theminimum temperature for safe oper-ation and two persons will perform thetests described in paragraphs (c) and(d) of this section, wearing the appara-tus according to applicant’s directions.At the specified temperature, the appa-ratus shall meet all the requirementsdescribed in paragraph (e) of this sec-tion.

(b) The apparatus will be precooled atthe specified minimum temperature for4 hours.

(c) The apparatus will be worn in thelow temperature chamber for 30 min-utes, or for the service time of the ap-paratus, whichever is less.

(d) During the test period, alternate1-minute periods of exercise and restwill be required with the exercise peri-ods consisting of stepping onto and offa box 21.5 cm. (81⁄2 inches) high at arate of 30 cycles per minute.

(e)(1) The apparatus shall functionsatisfactorily at the specified mini-mum temperature on duplicate tests.

(2) The wearer shall have sufficientunobscured vision to perform the work.

(3) The wearer shall not experienceundue discomfort because of airflow re-striction or other physical or chemicalchanges in the operation of the appara-tus.

(f) Auxiliary low-temperature partswhich are commercially available tothe user may be used on the apparatusto meet the requirements described inparagraph (e) of this section.

§ 84.99 Man tests; testing conditions;general requirements.

(a) The man tests described in Tables1, 2, 3, and 4 of this subpart representthe workload performed in the mining,mineral, or allied industries by a per-son wearing the apparatus tested.

(b) The apparatus tested will be wornby Institute personnel trained in theuse of self-contained breathing appara-tus, and the wearer will, before partici-pating in these tests, pass a physicalexamination conducted by a qualifiedphysician.

(c) All man tests will be conducted bythe Institute.

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547

Public Health Service, HHS § 84.103

(d) The apparatus will be examinedbefore each man test to ensure that itis in proper working order.

(e) Breathing resistance will be meas-ured within the facepiece or mouth-piece and the wearer’s pulse and res-piration rate will be recorded duringeach 2 minute sample period prescribedin tests 1, 2, 3, and 4.

(f) Man tests 1, 2, 3, 4, 5, and 6 will beconducted in duplicate.

(g) If man tests are not completedthrough no fault of the apparatus, thetest will be repeated.

§ 84.100 Man tests 1, 2, 3, and 4; re-quirements.

Man tests 1, 2, 3, and 4, set forth inTables 1, 2, 3, and 4 of this subpart, re-spectively, prescribe the duration andsequence of specific activities. Thesetests will be conducted to—

(a) Familiarize the wearer with theapparatus during use;

(b) Provide for a gradual increase inactivity;

(c) Evaluate the apparatus under dif-ferent types of work and physical ori-entation; and

(d) Provide information on the oper-ating and breathing characteristics ofthe apparatus during actual use.

§ 84.101 Man test 5; requirements.(a) Test 5 will be conducted to deter-

mine the maximum length of time theapparatus will supply the respiratoryneeds of the wearer while he is sittingat rest.

(b) The wearer will manipulate thedevices controlling the supply ofbreathing gas to the advantage of theapparatus.

(c) Samples of inspiration from with-in the apparatus facepiece or mouth-

piece shall be taken once every 15 min-utes, and shall meet the minimum re-quirement for oxygen specified in§ 84.79(a), and the maximum allowableaverage concentration of carbon diox-ide specified in § 84.97(c).

(d) One sample of inspiration will betaken in the case of 3-, 5-, and 10-minute apparatus.

§ 84.102 Man test 6; requirements.(a) Man test 6 will be conducted with

respect to liquefied breathing gas appa-ratus only.

(b) This test will be conducted toevaluate operation of the apparatus inother than vertical positions.

(c) The wearer will lie face downwardfor one-fourth the service life of the ap-paratus with a full charge of liquefiedbreathing gas, and then a one-quarterfull charge of liquefied breathing gas.

(d) The test will be repeated with thewearer lying on each side and on hisback.

(e) The oxygen content of the gassupplied to the wearer by the appara-tus will be continuously measured.

§ 84.103 Man tests; performance re-quirements.

(a) The apparatus shall satisfy therespiratory requirements of the wearerfor the classified service time.

(b) Fogging of the eyepiece shall notobscure the wearer’s vision, and thewearer shall not experience undue dis-comfort because of fit or other charac-teristics of the apparatus.

(c) When the ambient temperatureduring testing is 24±6 °C. (75±10 °F.), themaximum temperature of inspired airrecorded during man tests shall not ex-ceed the following, after correction fordeviation from 24 °C. (75 °F.):

Where service life of apparatus is—

Where percentrelative humid-ity of inspired

air is—

Maximum permissibletemperature of inspiredair shall not exceed—

°F. °C.

1⁄4 hour or less ........................................................................................................... 0–100 135 571⁄4 hour to 3⁄4 hour ..................................................................................................... 0–50

50–100125

1 11052

1 431 to 2 hours ............................................................................................................... 0–50

50–100115

110546

1413 hours ....................................................................................................................... 0–50

50–100110

110043

1 384 hours ....................................................................................................................... 0–50

50–1001051 95

411 35

1 Where percent relative humidity is 50–100 and apparatus is designed for escape only, these maximum permissible tempera-tures will be increased by 5°C (10°F).

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548

42 CFR Ch. I (10–1–97 Edition)§ 84.104

§ 84.104 Gas tightness test; minimumrequirements.

(a) Each apparatus will be tested fortightness by persons wearing it in anatmosphere of 1,000 p.p.m. isoamyl ace-tate.

(b) Six persons will each wear the ap-paratus in the test concentrationsspecified in paragraph (a) of this sec-tion for 2 minutes and none shall de-tect the odor or taste of the test vapor.

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549

Public Health Service, HHS § 84.104

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1 h

our

test

2,

3, o

r 4

times

res

pec-

tivel

y.W

alks

at

4.8

km.

(3 m

iles)

per

hou

r...

......

......

......

......

......

......

......

35

34

812

18S

ampl

ing

and

read

ings

......

......

......

......

......

......

......

......

......

......

.....

......

......

......

.....

......

......

.....

22

22

2W

alks

at

4.8

km.

(3 m

iles)

per

hou

r...

......

......

......

......

......

......

......

......

......

......

.....

......

......

.....

35

812

18S

ampl

ing

and

read

ings

......

......

......

......

......

......

......

......

......

......

.....

......

......

......

.....

......

......

.....

22

22

2W

alks

at

4.8

km.

(3 m

iles)

per

hou

r...

......

......

......

......

......

......

......

......

......

......

.....

......

......

.....

......

......

......

.....

......

......

.....

613

16S

ampl

ing

and

read

ings

......

......

......

......

......

......

......

......

......

......

.....

......

......

......

.....

......

......

.....

......

......

......

.....

......

......

.....

22

2

TA

BLE

2.—

DU

RA

TIO

NA

ND

SE

QU

EN

CE

OF

SP

EC

IFIC

AC

TIV

ITIE

SF

OR

TE

ST

2, IN

MIN

UT

ES

[42

CF

R p

art

84,

subp

art

H]

Act

ivity

Ser

vice

tim

e—

3 m

inut

es5

min

utes

10 m

inut

es15

min

utes

30 m

inut

es45

min

utes

1 ho

ur2,

3 a

nd 4

hou

rs1

Sam

plin

g an

d re

adin

gs...

......

......

......

......

......

......

......

......

......

......

.....

......

......

.....

......

......

......

......

2...

......

......

.....

2...

......

......

.....

2...

......

......

.....

2...

......

......

.....

2W

alks

at

4.8

km.

(3 m

iles)

per

hou

r...

......

......

......

....

......

......

......

.....

......

......

.....

1...

......

......

.....

1...

......

......

.....

3...

......

......

.....

4...

......

......

.....

6...

......

......

.....

10.

Car

ries

23 k

g. (

50 p

ound

) w

eigh

t ov

er o

verc

ast

......

......

......

......

.....

......

......

.....

1 tim

e in

2m

inut

es.

1 tim

e in

2m

inut

es.

2 tim

es in

4m

inut

es.

3 tim

es in

6m

inut

es.

4 tim

es in

8m

inut

es.

5 tim

es in

10

min

-ut

es.

Wal

ks a

t 4.

8 km

. (3

mile

s) p

er h

our

......

......

......

......

....

......

......

.....

......

......

......

.....

......

......

......

...1

......

......

......

..3

......

......

......

..3

......

......

......

..3

......

......

......

..5.

Clim

bs v

ertic

al t

read

mill

2(o

r eq

uiva

lent

)...

......

......

..1

11

......

......

......

..1

......

......

......

..1

......

......

......

..1

......

......

......

..1

......

......

......

..1.

Wal

ks a

t 4.

8 km

. (3

mile

s) p

er h

our

......

......

......

......

....

......

......

.....

11

......

......

......

.....

......

......

......

......

......

......

......

...2

......

......

......

..3

......

......

......

..5

Clim

bs v

ertic

al t

read

mill

(or

equ

ival

ent)

......

......

......

....

......

......

.....

1...

......

......

......

......

......

......

......

......

......

......

......

...1

......

......

......

..1

......

......

......

..1.

Sam

plin

g an

d re

adin

gs...

......

......

......

......

......

......

......

......

......

......

.....

......

......

.....

......

......

......

......

......

......

......

......

2...

......

......

.....

2...

......

......

.....

2...

......

......

.....

2.W

alks

at

4.8

km.

(3 m

iles)

per

hou

r...

......

......

......

....

......

......

......

.....

......

......

.....

......

......

......

......

2...

......

......

.....

2...

......

......

.....

3...

......

......

.....

5...

......

......

.....

11.

Clim

bs v

ertic

al t

read

mill

(or

equ

ival

ent)

......

......

......

....

......

......

.....

......

......

......

.....

......

......

......

...1

......

......

......

..1

......

......

......

..1

......

......

......

..1

......

......

......

..1.

Car

ries

23 k

g. (

50 p

ound

) w

eigh

t ov

er o

verc

ast

......

......

......

......

.....

......

......

.....

......

......

......

......

1 tim

e in

2m

inut

es.

3 tim

es in

6m

inut

es.

4 tim

es in

8m

inut

es.

5 tim

es in

10

min

utes

.5

times

in 1

0 m

in-

utes

.S

ampl

ing

and

read

ings

......

......

......

......

......

......

......

......

......

......

.....

......

......

......

..2

......

......

......

.....

......

......

......

......

......

......

......

...2

......

......

......

..2

......

......

......

..2.

Wal

ks a

t 4.

8 km

. (3

mile

s) p

er h

our

......

......

......

......

....

......

......

.....

......

......

......

.....

......

......

......

...1

......

......

......

..3

......

......

......

..3

......

......

......

..3

......

......

......

..C

limbs

ver

tical

tre

adm

ill (

or e

quiv

alen

t)...

......

......

....

......

......

......

.....

......

......

.....

1...

......

......

.....

1...

......

......

.....

1...

......

......

.....

1...

......

......

.....

1...

......

......

.....

The

n re

peat

abov

e ac

tiviti

eson

ce.

Wal

ks a

t 4.

8 km

. (3

mile

s) p

er h

our

......

......

......

......

....

......

......

.....

......

......

......

..2

......

......

......

.....

......

......

......

......

......

......

......

...2

......

......

......

..3.

Clim

bs v

ertic

al t

read

mill

(or

equ

ival

ent)

......

......

......

....

......

......

.....

......

......

......

.....

......

......

......

......

......

......

......

......

......

......

......

...1

......

......

......

..1

......

......

......

..

VerDate 02<DEC>97 10:06 Dec 23, 1997 Jkt 174160 PO 00000 Frm 00543 Fmt 8010 Sfmt 8010 C:\CFR\174160.TXT pfrm12

550

42 CFR Ch. I (10–1–97 Edition)§ 84.104

TA

BLE

2.—

DU

RA

TIO

NA

ND

SE

QU

EN

CE

OF

SP

EC

IFIC

AC

TIV

ITIE

SF

OR

TE

ST

2, IN

MIN

UT

ES—

Con

tinue

d[4

2 C

FR

par

t 84

, su

bpar

t H

]

Act

ivity

Ser

vice

tim

e—

3 m

inut

es5

min

utes

10 m

inut

es15

min

utes

30 m

inut

es45

min

utes

1 ho

ur2,

3 a

nd 4

hou

rs1

Car

ries

20 k

g. (

45 p

ound

) w

eigh

t an

d w

alks

at

4.8

km.

(3 m

iles)

per

hou

r.1

......

......

......

.....

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

...2

......

......

......

..

Wal

ks a

t 4.

8 km

. (3

mile

s) p

er h

our

......

......

......

......

.1

2...

......

......

......

......

......

......

......

......

......

......

......

...1

......

......

......

..4

......

......

......

..S

ampl

ing

and

read

ings

......

......

......

......

......

......

......

......

......

......

.....

......

......

......

.....

......

......

......

...2

......

......

......

..2

......

......

......

..2

......

......

......

..2

......

......

......

..

1T

otal

tes

t tim

e fo

r T

est

2 fo

r 2-

hour

, 3-

hour

, an

d 4-

hour

app

arat

us is

2 h

ours

.2

Tre

adm

ill s

hall

be in

clin

ed 1

5° fr

om v

ertic

al a

nd o

pera

ted

at a

spe

ed o

f 1

foot

per

sec

ond.

TA

BLE

3.—

DU

RA

TIO

NA

ND

SE

QU

EN

CE

OF

SP

EC

IFIC

AC

TIV

ITIE

SF

OR

TE

ST

3, IN

MIN

UT

ES

[42

CF

R p

art

84,

subp

art

H]

Act

ivity

Ser

vice

tim

e—

3 m

inut

es5

min

utes

10 m

inut

es15

min

utes

30 m

inut

es45

min

utes

1 ho

ur2,

3 a

nd 4

hour

s1

Sam

plin

g an

d re

adin

gs...

......

......

......

......

......

......

......

......

......

......

......

.....

......

......

......

......

......

......

......

...2

......

......

......

..2

......

......

......

..2

......

......

......

..2

......

......

......

..(2

)W

alks

at

4.8

km.

(3 m

iles)

per

hou

r...

......

......

......

......

....

......

......

......

.....

......

......

......

...1

......

......

......

..1

......

......

......

..2

......

......

......

..2

......

......

......

..3

......

......

......

.....

......

......

.....

Run

s at

9.7

km

. (6

mile

s) p

er h

our

......

......

......

......

......

..1

1...

......

......

.....

1...

......

......

.....

1...

......

......

.....

1...

......

......

.....

1...

......

......

.....

1...

......

......

.....

......

......

......

..P

ulls

20

kg.

(45

poun

d) w

eigh

t to

5 f

eet

......

......

......

......

......

......

......

..15

tim

es in

1m

inut

e....

......

......

......

...30

tim

es in

2m

inut

es.

30 t

imes

in 2

min

utes

.30

tim

es in

2m

inut

es.

60 t

imes

in 6

min

utes

....

......

......

.....

Lies

on

side

......

......

......

......

......

......

......

......

......

......

......

...1/

21

......

......

......

..1

......

......

......

..2

......

......

......

..3

......

......

......

..4

......

......

......

..5

......

......

......

.....

......

......

.....

Lies

on

back

......

......

......

......

......

......

......

......

......

......

......

..1/

21

......

......

......

..1

......

......

......

..2

......

......

......

..2

......

......

......

..3

......

......

......

..3

......

......

......

.....

......

......

.....

Cra

wls

on

hand

s an

d kn

ees

......

......

......

......

......

......

......

.1

1...

......

......

.....

1...

......

......

.....

2...

......

......

.....

2...

......

......

.....

2...

......

......

.....

2...

......

......

.....

......

......

......

..S

ampl

ing

and

read

ings

......

......

......

......

......

......

......

......

......

......

......

.....

......

......

......

......

2...

......

......

.....

......

......

......

......

2...

......

......

.....

2...

......

......

.....

2...

......

......

.....

......

......

......

..R

uns

at 9

.7 k

m.

(6 m

iles)

per

hou

r...

......

......

......

......

.....

......

......

......

.....

......

......

......

......

......

......

......

...1

......

......

......

..1

......

......

......

..1

......

......

......

..1

......

......

......

.....

......

......

.....

Wal

ks a

t 4.

8 km

. (3

mile

s) p

er h

our

......

......

......

......

......

....

......

......

.....

......

......

......

......

......

......

......

......

......

......

......

......

2...

......

......

.....

8...

......

......

.....

10...

......

......

......

......

......

.....

Pul

ls 2

0 kg

. (4

5 po

und)

wei

ght

to 5

fee

t...

......

......

......

......

......

......

.....

......

......

......

......

30 t

imes

in 2

min

utes

....

......

......

......

...60

tim

es in

6m

inut

es.

60 t

imes

in 6

min

utes

.60

tim

es in

6m

inut

es.

......

......

......

..

Sam

plin

g an

d re

adin

gs...

......

......

......

......

......

......

......

......

......

......

......

.....

......

......

......

......

......

......

......

...2

......

......

......

.....

......

......

......

...2

......

......

......

..2

......

......

......

.....

......

......

.....

Wal

ks a

t 4.

8 km

. (3

mile

s) p

er h

our

......

......

......

......

......

....

......

......

.....

......

......

......

......

1...

......

......

.....

......

......

......

......

3...

......

......

.....

4...

......

......

.....

10...

......

......

......

......

......

.....

Lies

on

side

......

......

......

......

......

......

......

......

......

......

......

......

......

......

.....

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

2...

......

......

.....

4...

......

......

.....

......

......

......

..Li

es o

n ba

ck...

......

......

......

......

......

......

......

......

......

......

.....

......

......

......

.....

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

...2

......

......

......

..1

......

......

......

.....

......

......

.....

Sam

plin

g an

d re

adin

gs...

......

......

......

......

......

......

......

......

......

......

......

.....

......

......

......

......

......

......

......

......

......

......

......

...2

......

......

......

..2

......

......

......

..2

......

......

......

.....

......

......

.....

1T

otal

tes

t tim

e fo

r T

est

3 fo

r 2-

hour

, 3-

hour

, an

d 4-

hour

app

arat

us is

2 h

ours

.2

Per

form

tes

t N

o. 3

for

1 h

r. a

ppar

atus

; th

en p

erfo

rm t

est

No.

1 f

or 1

hou

r ap

para

tus.

VerDate 02<DEC>97 10:06 Dec 23, 1997 Jkt 174160 PO 00000 Frm 00544 Fmt 8010 Sfmt 8010 C:\CFR\174160.TXT pfrm12

551

Public Health Service, HHS § 84.104

TA

BLE

4.—

DU

RA

TIO

NA

ND

SE

QU

EN

CE

OF

SP

EC

IFIC

AC

TIV

ITIE

SF

OR

TE

ST

4, IN

MIN

UT

ES

[42

CF

R p

art

84,

subp

art

H]

Act

ivity

Ser

vice

tim

e—

3 m

inut

es5

min

utes

10 m

inut

es15

min

utes

30 m

inut

es45

min

utes

1 ho

ur2

hour

s3

hour

s4

hour

s

Sam

plin

g an

d re

adin

gs...

......

.....

......

......

......

......

......

......

......

......

......

......

......

...2

......

......

......

..2

......

......

......

..2

......

......

......

..2

......

......

......

..(2

)(3

)(4

)W

alks

at

4.8

km.

(3 m

iles)

per

hour

....

......

......

......

......

......

......

......

......

......

......

......

...1

......

......

......

..2

......

......

......

..2

......

......

......

..2

......

......

......

.....

......

......

....

......

......

....

......

......

.

Clim

bs v

ertic

al t

read

mill

1(o

req

uiva

lent

).1

......

......

......

..1

......

......

......

..1

......

......

......

..1

......

......

......

..1

......

......

......

..1

......

......

......

..1

......

......

......

.....

......

......

....

......

......

....

......

......

.

Wal

ks a

t 4.

8 km

. (3

mile

s) p

erho

ur.

......

......

......

......

1...

......

......

.....

1...

......

......

.....

1...

......

......

.....

2...

......

......

.....

2...

......

......

.....

2...

......

......

....

......

......

....

......

......

.

Pul

ls 2

0 kg

. (4

5 po

und)

wei

ght

to 5

fee

t....

......

......

......

...30

tim

es in

2m

inut

es.

30 t

imes

in 2

min

utes

.30

tim

es in

2m

inut

es.

60 t

imes

in 5

min

utes

.60

tim

es in

5m

inut

es.

60 t

imes

in 5

min

utes

....

......

......

....

......

......

....

......

......

.

Wal

ks a

t 4.

8 km

. (3

mile

s) p

erho

ur.

......

......

......

......

......

......

......

......

1...

......

......

.....

1...

......

......

.....

1...

......

......

.....

2...

......

......

.....

3...

......

......

.....

......

......

....

......

......

....

......

......

....

Car

ries

23 k

g. (

50 p

ound

)w

eigh

t ov

er o

verc

ast.

......

......

......

......

......

......

......

......

......

......

......

......

1 tim

e in

1m

inut

e.1

time

in 1

min

ute.

2 tim

es in

3m

inut

es.

4 tim

es in

8m

inut

es.

......

......

....

......

......

....

......

......

....

Sam

plin

g an

d re

adin

gs...

......

.....

......

......

......

......

......

......

......

...2

......

......

......

.....

......

......

......

...2

......

......

......

..2

......

......

......

..2

......

......

......

.....

......

......

....

......

......

....

......

......

.W

alks

at

4.8

km.

(3 m

iles)

per

hour

....

......

......

......

......

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tical

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ope

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d at

a s

peed

of

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m.

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oot)

per

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ond.

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rm t

est

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1 f

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0-m

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para

tus;

the

n pe

rfor

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est

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n pe

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est

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one-

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tes

ts).

VerDate 02<DEC>97 10:06 Dec 23, 1997 Jkt 174160 PO 00000 Frm 00545 Fmt 8010 Sfmt 8010 C:\CFR\174160.TXT pfrm12

552

42 CFR Ch. I (10–1–97 Edition)§ 84.110

Subpart I—Gas Masks

§ 84.110 Gas masks; description.

(a) Gas masks including all com-pletely assembled air purifying masksdesigned for use as respiratory protec-tion during entry into atmospheres notimmediately dangerous to life orhealth or escape only from hazardousatmospheres containing adequate oxy-gen to support life are described as fol-lows:

(1) Front-mounted or back-mounted gasmask. A gas mask which consists of afull facepiece, a breathing tube, a can-ister at the front or back, a canisterharness, and associated connections.

(2) Chin-style gas mask. A gas maskwhich consists of a full facepiece, acanister which is usually attached tothe facepiece, and associated connec-tions.

(3) Escape gas mask. A gas mask de-signed for use during escape only fromhazardous atmospheres which consistsof a facepiece or mouthpiece, a can-ister, and associated connections.

(b) Gas masks shall be further de-scribed according to the types of gasesor vapors against which they are de-signed to provide respiratory protec-tion, as follows:

Type of front-mounted or back-mounted gas mask:Acid gas 1 2 3

AmmoniaCarbon monoxideOrganic Vapor 1 2 3

Other gas(es) and vapor(s) 1 2 3

Combination of two or more of the above gasesand vapors.1 2 3

Combination of acid gas, ammonia, carbon mon-oxide, and organic vapors.1 2 3

Type of chin-style gas mask:Acid gas 1 2 3

AmmoniaCarbon monoxideOrganic vapor 1 2 3

Other gas(es) and vapor 1 2 3

Combination of two or more of the above gasesand vapors.1 2 3

Type of escape gas mask:Acid gas 1 2 3 4

Ammonia 4

Carbon monoxideOrganic vapor 1 2 3 4

Other gas(s) and vapor(s) 1 2 3 4

Combination of two or more of the above gasesand vapors. 1 2 3 4

1 Approval may be for acid gases or organicvapors as a class or for specific acid gases ororganic vapors.

2 Not for use against gases or vapors withpoor warning properties (except where MSHAor Occupational Safety and Health Administra-tion standards permit such use for a specificgas or vapor), or those which generate highheats or reaction with sorbent materials in thecanister.

3 Use of the gas mask may be limited by fac-tors such as lower explosive limit, toxicologicaleffects, and facepiece fit. Limitations on gasmask service life and sorbent capacity limita-tions shall be specified by the applicant in in-structions for selection, use and maintenanceof the gas mask.

4 Eye protection may be required in certainconcentrations of gases and vapors.

(c) Gas masks for respiratory protec-tion against gases and vapors otherthan those specified in paragraph (b) ofthis section, may be approved uponsubmittal of an application in writingfor approval to the Certification andQuality Assurance Branch listing thegas or vapor and suggested maximumuse concentration for the specific typeof gas mask. The Institute will con-sider the application and accept or re-ject it on the basis of effect on thewearer’s health and safety and anyfield experience in use of gas masks forsuch exposures. If the application is ac-cepted, the Institute will test suchmasks in accordance with the require-ments of this subpart.

§ 84.111 Gas masks; required compo-nents.

(a) Each gas mask described in§ 84.110 shall, where its design requires,contain the following component parts:

(1) Facepiece or mouthpiece andnoseclip;

(2) Canister or cartridge;(3) Canister harness;(4) External check valve; and(5) Breathing tube.(b) The components of each gas mask

shall meet the minimum constructionrequirements set forth in subpart G ofthis part.

VerDate 02<DEC>97 10:06 Dec 23, 1997 Jkt 174160 PO 00000 Frm 00546 Fmt 8010 Sfmt 8010 C:\CFR\174160.TXT pfrm12

553

Public Health Service, HHS § 84.118

§ 84.112 Canisters and cartridges inparallel; resistance requirements.

Where two or more canisters or car-tridges are used in parallel, their re-sistance to airflow shall be essentiallyequal.

§ 84.113 Canisters and cartridges;color and markings; requirements.

The color and markings of all can-isters and cartridges or labels shallconform with the requirements of theAmerican National Standards Insti-tute, American National Standard forIdentification of Air-Purifying Res-pirator Canisters and Cartridges, ANSIK13.1–1973. ANSI K13.1 is incorporatedby reference and has been approved bythe Director of the Federal Register inaccordance with 5 U.S.C. 552(a) and 1CFR part 51. Copies may be obtainedfrom American National Standards In-stitute, Inc., 1430 Broadway, New York,NY 10018. Copies may be inspected atthe NIOSH, Certification and QualityAssurance Branch, 1095 WillowdaleRoad, Morgantown, WV 26505–2888, orat the Office of the Federal Register,800 North Capitol Street, NW., suite700, Washington, DC.

§ 84.114 Filters used with canistersand cartridges; location; replace-ment.

(a) Particulate matter filters used inconjunction with a canister or car-tridge shall be located on the inlet sideof the canister or cartridge.

(b) Filters shall be incorporated in orfirmly attached to the canister or car-tridge and each filter assembly shall,where applicable, be designed to permitits easy removal from and replacementin the canister or cartridge.

§ 84.115 Breathing tubes; minimum re-quirements.

Flexible breathing tubes used in con-junction with gas masks shall be de-signed and constructed to prevent:

(a) Restriction of free head move-ment;

(b) Disturbance of the fit offacepieces or mouthpieces;

(c) Interference with the wearer’s ac-tivities; and

(d) Shutoff of airflow due to kinking,or from chin or arm pressure.

§ 84.116 Harnesses; installation andconstruction; minimum require-ments.

(a) Each gas mask shall, where nec-essary, be equipped with a suitable har-ness designed and constructed to holdthe components of the gas mask in po-sition against the wearer’s body.

(b) Harnesses shall be designed andconstructed to permit easy removaland replacement of gas mask parts, andwhere applicable, provide for holding afull facepiece in the ready positionwhen not in use.

§ 84.117 Gas mask containers; mini-mum requirements.

(a) Gas masks shall be equipped witha substantial, durable container bear-ing markings which show the appli-cant’s name, the type and commercialdesignation of mask it contains and allappropriate approval labels.

(b) Containers for gas masks shall bedesigned and constructed to permiteasy removal of the mask.

§ 84.118 Half-mask facepieces, fullfacepieces, and mouthpieces; fit;minimum requirements.

(a) Half-mask facepieces and fullfacepieces shall be designed and con-structed to fit persons with various fa-cial shapes and sizes either:

(1) By providing more than one face-piece size; or

(2) By providing one facepiece sizewhich will fit varying facial shapes andsizes.

(b) Full facepieces shall provide foroptional use of corrective spectacles orlenses, which shall not reduce the res-piratory protective qualities of the gasmask.

(c) Half-mask facepieces shall notinterfere with the fit of common indus-trial safety spectacles, as determinedby the Institute’s facepiece tests in§ 84.124.

(d) Gas masks with mouthpieces shallbe equipped with noseclips which aresecurely attached to the mouthpiece orgas mask and provide an airtight seal.

(e) Facepieces shall be designed toprevent eyepiece fogging.

VerDate 02<DEC>97 10:06 Dec 23, 1997 Jkt 174160 PO 00000 Frm 00547 Fmt 8010 Sfmt 8010 C:\CFR\174160.TXT pfrm12

554

42 CFR Ch. I (10–1–97 Edition)§ 84.119

§ 84.119 Facepieces; eyepieces; mini-mum requirements.

(a) Full facepieces shall be designedand constructed to provide adequate vi-sion which is not distorted by the eye.

(b) All eyepieces shall be designedand constructed to be impact and pene-tration resistant. Federal Specifica-tion, Mask, Air Line: and Respirator,Air Filtering, Industrial, GGG–M–125d,October 11, 1965 with interim amend-ment-1, July 30, 1969, is an example ofan appropriate standard for determin-ing impact and penetration resistance.Copies of GGG–M–125d may be obtainedfrom the NIOSH, Certification andQuality Assurance Branch, 1095Willowdale Road, Morgantown, WV26505–2888.

§ 84.120 Inhalation and exhalationvalves; minimum requirements.

(a) Inhalation and exhalation valvesshall be provided where necessary andprotected against damage and distor-tion.

(b) Inhalation valves shall be de-signed and constructed to prevent ex-cessive exhaled air from adversely af-fecting cartridges, canisters, and fil-ters.

(c) Exhalation valves shall be pro-tected against external influence, and

designed and constructed to prevent in-ward leakage of contaminated air.

§ 84.121 Head harnesses; minimum re-quirements.

(a) Facepieces shall be equipped withadjustable and replaceable head har-nesses, designed and constructed toprovide adequate tension during useand an even distribution of pressureover the entire area in contact withthe face.

(b) Mouthpieces shall be equipped,where applicable, with adjustable andreplaceable harnesses designed andconstructed to hold the mouthpiece inplace.

§ 84.122 Breathing resistance test; min-imum requirements.

(a) Resistance to airflow will bemeasured in the facepiece or mouth-piece of a gas mask mounted on abreathing machine both before andafter each test conducted in accordancewith §§ 84.124, 84.125, and 84.126, with airflowing at a continuous rate of 85 litersper minute.

(b) The maximum allowable resist-ance requirements for gas masks are asfollows:

MAXIMUM RESISTANCE[mm. water-column height]

Type of gas maskInhalation

ExhalationInitial Final 1

Front-mounted or back-mounted (without particulate filter) .......................................... 60 75 20Front-mounted or back-mounted (with approved particulate filter) ............................... 70 85 20Chin-style (without particulate filter) .............................................................................. 40 55 20Chin-style (with approved particulate filter) ................................................................... 65 80 20Escape (without particulate filter) .................................................................................. 60 75 20Escape (with approved particulate filter) ....................................................................... 70 85 20

1 Measured at end of the service life specified in Tables 5, 6, and 7 of this subpart.

§ 84.123 Exhalation valve leakage test.

(a) Dry exhalation valves and valveseats will be subjected to a suction of25 mm. water-column height while in anormal operating position.

(b) Leakage between the valve andvalve seat shall not exceed 30 milli-liters per minute.

§ 84.124 Facepiece tests; minimum re-quirements.

(a) The complete gas mask will befitted to the faces of persons havingvarying facial shapes and sizes.

(b) Where the applicant specifies afacepiece size or sizes for the gas mask,together with the approximate meas-urements of faces they are designed tofit, the Institute will insure that test

VerDate 02<DEC>97 10:06 Dec 23, 1997 Jkt 174160 PO 00000 Frm 00548 Fmt 8010 Sfmt 8010 C:\CFR\174160.TXT pfrm12

555

Public Health Service, HHS § 84.126

subjects suit such facial measure-ments.

(c) Any gas mask parts which mustbe removed to perform the facepiece ormouthpiece fit test shall be replaceablewithout special tools and without dis-turbing the facepiece or mouthpiecefit.

(d) The facepiece or mouthpiece fittest, using positive or negative pres-sure recommended by the applicantand described in his instructions willbe used before each test specified inparagraph (e) of this section, and in§ 84.125.

(e)(1) Each wearer will enter a cham-ber containing 100 p.p.m. isoamyl ace-tate vapor for a half-mask facepieceand 1,000 p.p.m. isoamyl acetate vaporfor a full facepiece or mouthpiece.

(2) The facepiece or mouthpiece maybe adjusted, if necessary, in the testchamber before starting the tests.

(3) Each wearer will remain in thechamber for 8 minutes while perform-ing the following activities:

(i) Two minutes, nodding and turninghead;

(ii) Two minutes, calisthenic armmovements;

(iii) Two minutes, running in place;and

(iv) Two minutes, pumping with atire pump into a 28 liter (1 cubic foot)container.

(4) Each wearer shall not detect theodor of isoamyl acetate during thetest.

§ 84.125 Particulate tests; canisterscontaining particulate filters; mini-mum requirements.

Gas mask canisters containing filtersfor protection against particulates (e.g.dusts, fumes, mists, and smokes) incombination with gases, vapors, orgases and vapors, shall also complywith the requirements as prescribed in§§ 84.170 through 84.183, except for theairflow resistance test of § 84.181.

§ 84.126 Canister bench tests; mini-mum requirements.

(a)(1) Bench tests, except for carbonmonoxide tests, will be made on an ap-paratus that allows the test atmos-

phere at 50±5 percent relative humidityand room temperature (25±2.5 °C.) toenter the canister continuously at con-centrations and rates of flow specifiedin Tables 5, 6, and 7 of this subpart.

(2) Three canisters will be removedfrom containers and tested as receivedfrom the applicant.

(3) Two canisters, other than thosedescribed in paragraph (a)(2) of thissection, will be equilibrated at roomtemperature by passing 25 percent rel-ative humidity air through them at 64liters per minute for 6 hours.

(4) Two canisters, other than thosedescribed in paragraphs (a) (2) and (3)of this section, will be equilibrated atroom temperature by passing 85 per-cent relative humidity air throughthem at 64 liters per minute for 6hours.

(5) The equilibrated canisters will beresealed, kept in an upright position atroom temperature, and tested within 18hours.

(b) Front-mounted and back-mountedgas mask canisters will be tested andshall meet the minimum requirementsset forth in Table 5 of this subpart.

(c)(1) Front-mounted, and back-mounted, and chin-style canisters des-ignated as providing respiratory pro-tection against gases, ammonia, or-ganic vapors, carbon monoxide and par-ticulate contaminants shall have awindow or other indicator to warn thegas mask wearer when the canister willno longer satisfactorily remove carbonmonoxide from the inhaled air.

(2) Other types of front- and back-mounted canisters may also beequipped with a window or other indi-cator to warn of imminent leakage ofother gases or vapors.

(3) The window indicator canisterswill be tested as regular canisters, butshall show a satisfactory indicatorchange or other warning before the al-lowable canister penetration has oc-curred.

(d) Chin-style gas mask canistersshall meet the minimum requirementsset forth in Table 6 of this subpart.

(e) Escape gas mask canisters shallmeet the minimum requirements setforth in Table 7 of this subpart.

VerDate 02<DEC>97 10:06 Dec 23, 1997 Jkt 174160 PO 00000 Frm 00549 Fmt 8010 Sfmt 8010 C:\CFR\174160.TXT pfrm12

556

42 CFR Ch. I (10–1–97 Edition)§ 84.126

TA

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558

42 CFR Ch. I (10–1–97 Edition)§ 84.130

Subpart J—Supplied-AirRespirators

§ 84.130 Supplied-air respirators; de-scription.

Supplied-air respirators, includingall completely assembled respiratorsdesigned for use as respiratory protec-tion during entry into and escape fromatmospheres not immediately dan-gerous to life or health are described asfollows:

(a) Type ‘‘A’’ supplied-air respirators. Ahose mask respirator, for entry intoand escape from atmospheres not im-mediately dangerous to life or health,which consists of a motor-driven orhand-operated blower that permits thefree entrance of air when the blower isnot operating, a strong large-diameterhose having a low resistance to airflow,a harness to which the hose and thelife-line are attached and a tight-fit-ting facepiece.

(b) Type ‘‘AE’’ supplied-air respirators.A Type ‘‘A’’ supplied-air respiratorequipped with additional devices de-signed to protect the wearer’s head andneck against impact and abrasion fromrebounding abrasive material, and withshielding material such as plastic,glass, woven wire, sheet metal, orother suitable material to protect thewindow(s) of facepieces, hoods, and hel-mets which do not unduly interferewith the wearer’s vision and permiteasy access to the external surface ofsuch window(s) for cleaning.

(c) Type ‘‘B’’ supplied-air respirators. Ahose mask respirator, for entry intoand escape from atmospheres not im-mediately dangerous to life or health,which consists of a strong large-diame-ter hose with low resistance to airflowthrough which the user draws inspiredair by means of his lungs alone, a har-ness to which the hose is attached, anda tight-fitting facepiece.

(d) Type ‘‘BE’’ supplied-air respirators.A type ‘‘B’’ supplied-air respiratorequipped with additional devices de-signed to protect the wearer’s head andneck against impact and abrasion fromrebounding abrasive material, and withshielding material such as plastic,glass, woven wire, sheet metal, orother suitable material to protect thewindow(s) of facepieces, hoods, and hel-mets which do not unduly interfere

with the wearer’s vision and permiteasy access to the external surface ofsuch window(s) for cleaning.

(e) Type ‘‘C’’ supplied-air respirators.An airline respirator, for entry intoand escape from atmospheres not im-mediately dangerous to life or health,which consists of a source of respirablebreathing air, a hose, a detachable cou-pling, a control valve, orifice, a de-mand valve or pressure demand valve,an arrangement for attaching the hoseto the wearer, and a facepiece, hood, orhelmet.

(f) Type ‘‘CE’’ supplied-air respirators.A type ‘‘C’’ supplied-air respiratorequipped with additional devices de-signed to protect the wearer’s head andneck against impact and abrasion fromrebounding abrasive material, and withshielding material such as plastic,glass, woven wire, sheet metal, orother suitable material to protect thewindow(s) of facepieces, hoods, and hel-mets which do not unduly interferewith the wearer’s vision and permiteasy access to the external surface ofsuch window(s) for cleaning.

§ 84.131 Supplied-air respirators; re-quired components.

(a) Each supplied-air respirator de-scribed in § 84.130 shall, where its de-sign requires, contain the followingcomponent parts:

(1) Facepiece, hood, or helmet;(2) Air supply valve, orifice, or de-

mand or pressure-demand regulator;(3) Hand operated or motor driven air

blower;(4) Air supply hose;(5) Detachable couplings;(6) Flexible breathing tube; and(7) Respirator harness.(b) The component parts of each sup-

plied-air respirator shall meet the min-imum construction requirements setforth in subpart G of this part.

§ 84.132 Breathing tubes; minimum re-quirements.

Flexible breathing tubes used in con-junction with supplied-air respiratorsshall be designed and constructed toprevent:

(a) Restriction of free head move-ment;

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559

Public Health Service, HHS § 84.138

(b) Disturbance of the fit offacepieces, mouthpieces, hoods, or hel-mets;

(c) Interference with the wearer’s ac-tivities; and

(d) Shutoff of airflow due to kinking,or from chin or arm pressure.

§ 84.133 Harnesses; installation andconstruction; minimum require-ments.

(a) Each supplied-air respirator shall,where necessary, be equipped with asuitable harness designed and con-structed to hold the components of therespirator in position against the wear-er’s body.

(b) Harnesses shall be designed andconstructed to permit easy removaland replacement of respirator parts,and where applicable, provide for hold-ing a full facepiece in the ready posi-tion when not in use.

§ 84.134 Respirator containers; mini-mum requirements.

Supplied-air respirators shall beequipped with a substantial, durablecontainer bearing markings whichshow the applicant’s name, the typeand commercial designation of the res-pirator it contains, and all appropriateapproval labels.

§ 84.135 Half-mask facepieces, fullfacepieces, hoods, and helmets; fit;minimum requirements.

(a) Half-mask facepieces and fullfacepieces shall be designed and con-structed to fit persons with various fa-cial shapes and sizes either:

(1) By providing more than one face-piece size; or

(2) By providing one facepiece sizewhich will fit varying facial shapes andsizes.

(b) Full facepieces shall provide foroptional use of corrective spectacles orlenses, which shall not reduce the res-piratory protective qualities of the res-pirator.

(c) Hoods and helmets shall be de-signed and constructed to fit personswith various head sizes, provide for theoptional use of corrective spectacles orlenses, and insure against any restric-tion of movement by the wearer.

(d) Facepieces, hoods, and helmetsshall be designed to prevent eyepiecefogging.

§ 84.136 Facepieces, hoods, and hel-mets; eyepieces; minimum require-ments.

(a) Facepieces, hoods, and helmetsshall be designed and constructed toprovide adequate vision which is notdistorted by the eyepiece.

(b) All eyepieces except those onTypes B, BE, C, and CE supplied-airrespirators shall be designed and con-structed to be impact and penetrationresistant. Federal Specification, Mask,Air Line: and Respirator, Air Filtering,Industrial, GGG–M–125d, October 11,1965 with interim amendment-1, July30, 1969, is an example of an appropriatestandard for determining impact andpenetration resistance. Copies of GGG–M–125d may be obtained from theNIOSH, Certification and Quality As-surance Branch, 1095 Willowdale Road,Morgantown, WV 26505–2888.

(c)(1) The eyepieces of AE, BE, andCE type supplied-air respirators shallbe shielded by plastic, glass, wovenwire, sheet metal, or other suitablematerial which does not interfere withthe vision of the wearer.

(2) Shields shall be mounted and at-tached to the facepiece to provide easyaccess to the external surface of theeyepiece for cleaning.

§ 84.137 Inhalation and exhalationvalves; check valves; minimum re-quirements.

(a) Inhalation and exhalation valvesshall be provided where necessary andprotected against distortion.

(b) Exhalation valves shall be:(1) Protected against damage and ex-

ternal influence; and(2) Designed and constructed to pre-

vent inward leakage of contaminatedair.

(c) Check valves designed and con-structed to allow airflow toward thefacepiece only shall be provided in theconnections to the facepiece or in thehose fitting near the facepiece of allType A, AE, B, and BE supplied-air res-pirators.

§ 84.138 Head harnesses; minimum re-quirements.

Facepieces shall be equipped with ad-justable and replaceable head har-nesses which are designed and con-structed to provide adequate tension

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560

42 CFR Ch. I (10–1–97 Edition)§ 84.139

during use, and an even distribution ofpressure over the entire area in contactwith the face.

§ 84.139 Head and neck protection;supplied-air respirators; minimumrequirements.

Type AE, BE, and CE supplied-airrespirators shall be designed and con-structed to provide protection againstimpact and abrasion from reboundingabrasive materials to the wearer’s headand neck.

§ 84.140 Air velocity and noise levels;hoods and helmets; minimum re-quirements.

Noise levels generated by the res-pirator will be measured inside thehood or helmet at maximum airflowobtainable within pressure and hoselength requirements and shall not ex-ceed 80 dBA.

§ 84.141 Breathing gas; minimum re-quirements.

(a) Breathing gas used to supply sup-plied-air respirators shall be respirablebreathing air and contain no less than19.5 volume-percent of oxygen.

(b) Compressed, gaseous breathing airshall meet the applicable minimumgrade requirements for Type I gaseousair set forth in the Compressed Gas As-sociation Commodity Specification forAir, G–7.1, 1966 (Grade D or higher qual-ity). G–7.1 is incorporated by referenceand has been approved by the Directorof the Federal Register in accordancewith 5 U.S.C. 552(a) and 1 CFR part 51.Copies may be obtained from AmericanNational Standards Institute, Inc., 1430Broadway, New York, NY 10018. Copiesmay be inspected at the NIOSH, Cer-tification and Quality AssuranceBranch, 1095 Willowdale Road, Morgan-town, WV 26505–2888, or at the Office ofthe Federal Register, 800 North CapitolStreet, NW., suite 700, Washington, DC.

(c) Compressed, liquefied breathingair shall meet the applicable minimumgrade requirements for Type II liquidair set forth in the Compressed Gas As-sociation Commodity Specification forAir, G–7.1, 1966 (Grade B or higher qual-ity). G–7.1 is incorporated by referenceand has been approved by the Directorof the Federal Register in accordancewith 5 U.S.C. 552(a) and 1 CFR part 51.

Copies may be obtained from AmericanNational Standards Institute, Inc., 1430Broadway, New York, NY 10018. Copiesmay be inspected at the NIOSH, Cer-tification and Quality AssuranceBranch, 1095 Willowdale Road, Morgan-town, WV 26505–2888, or at the Office ofthe Federal Register, 800 North CapitolStreet, NW., suite 700, Washington, DC.

§ 84.142 Air supply source; hand-oper-ated or motor driven air blowers;Type A supplied-air respirators;minimum requirements.

(a) Blowers shall be designed and con-structed to deliver an adequate amountof air to the wearer with either direc-tion of rotation, unless constructed topermit rotation in one direction only,and to permit the free entrance of airto the hose when the blower is not op-erated.

(b) No multiple systems, wherebymore than one user is supplied by oneblower, will be approved, unless eachhose line is connected directly to amanifold at the blower.

§ 84.143 Terminal fittings or chambers;Type B supplied-air respirators;minimum requirements.

(a) Blowers or connections to air sup-plies providing positive pressures shallnot be approved for use on Type B sup-plied-air respirators.

(b) Terminal fittings or chambersemployed in Type B supplied-air res-pirators, shall be:

(1) Installed in the inlet of the hose.(2) Designed and constructed to pro-

vide for the drawing of air through cor-rosion resistant material arranged soas to be capable of removing materiallarger than 0.149 mm. in diameter (149micrometers, 100-mesh, U.S. Standardsieve).

(3) Installed to provide a means forfastening or anchoring the fitting orchamber in a fixed position in a zone ofrespirable air.

§ 84.144 Hand-operated blower test;minimum requirements.

(a) Hand-operated blowers shall betested by attaching them to a mechani-cal drive and operating them 6 to 8hours daily for a period of 100 hours ata speed necessary to deliver 50 liters of

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561

Public Health Service, HHS § 84.146

air per minute through each com-pletely assembled respirator. Each res-pirator shall be equipped with the max-imum length of hose with which the de-vice is to be approved and the hoseshall be connected to each blower ormanifold outlet designed for hose con-nections.

(b) The crank speed of the hand-oper-ated blower shall not exceed 50 revolu-tions per minute in order to deliver therequired 50 liters of air per minute toeach facepiece.

(c) The power required to deliver 50liters of air per minute to each wearerthrough the maximum length of hoseshall not exceed one-fiftieth horse-power, and the torque shall not exceeda force of 2.3 kg. (5 pounds) on a 20 cm.(8-inch) crank, as defined in § 84.146.

(d) The blower shall operate through-out the period without failure or indi-cation of excessive wear of bearings orother working parts.

§ 84.145 Motor-operated blower test;minimum requirements.

(a) Motor-operated blowers shall betested by operating them at their spec-ified running speed 6 to 8 hours dailyfor a period of 100 hours when assem-bled with the kind and maximumlength of hose for which the device isto be approved and when connected toeach blower or manifold outlet de-signed for hose connections.

(b) The connection between themotor and the blower shall be so con-structed that the motor may be dis-engaged from the blower when theblower is operated by hand.

(c) The blower shall operate through-out the period without failure or indi-cation of excessive wear of bearings orother working parts.

(d) Where a blower, which is ordi-narily motor driven, is operated byhand, the power required to deliver 50

liters of air per minute to each wearerthrough the maximum length of hoseshall not exceed one-fiftieth horse-power, and the torque shall not exceeda force of 2.3 kg. (5 pounds) on a 20 cm.(8-inch) crank, as defined in § 84.146.

(e) Where the respirator is assembledwith the facepiece and 15 m. (50 feet) ofthe hose for which it is to be approved,and when connected to one outlet withall other outlets closed and operated ata speed not exceeding 50 revolutions ofthe crank per minute, the amount ofair delivered into the respiratory-inletcovering shall not exceed 150 liters perminute.

§ 84.146 Method of measuring thepower and torque required to oper-ate blowers.

As shown in Figure 1 of this section,the blower crank is replaced by a wood-en drum, a (13 cm. (5 inches) in diame-ter is convenient). This drum is woundwith about 12 m. (40 feet) of No. 2 pic-ture cord, b. A weight, c, of sufficientmass to rotate the blower at the de-sired speed is suspended from this wirecord. A mark is made on the cord about3 to 4.5 m. (10 to 15 feet) from theweight, c. Another mark is placed at ameasured distance (6–9 m./20–30 feet isconvenient) from the first. These areused to facilitate timing. To determinethe torque or horsepower required tooperate the blower, the drum is startedin rotation manually at or slightlyabove the speed at which the powermeasurement is to be made. The bloweris then permitted to assume constantspeed, and then as the first mark onthe wire leaves the drum, a stopwatchis started. The watch is stopped whenthe second mark leaves the drum.From these data the foot-pounds perminute and the torque may be cal-culated.

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562

42 CFR Ch. I (10–1–97 Edition)§ 84.147

FIGURE 1—APPARATUS FOR MEASURING POWER REQUIRED TO OPERATE BLOWER. (42 CFR PART84, SUBPART J, § 84.146)

§ 84.147 Type B supplied-air res-pirator; minimum requirements.

No Type B supplied-air respiratorshall be approved for use with a bloweror with connection to an air supply de-vice at positive pressures.

§ 84.148 Type C supplied-air res-pirator, continuous flow class; mini-mum requirements.

(a) Respirators tested under this sec-tion shall be approved only when theysupply respirable air at the pressuresand quantities required.

(b) The pressure at the inlet of thehose connection shall not exceed 863kN/m.2 (125 pounds per square inchgage).

(c) Where the pressure at any pointin the supply system exceeds 863 kN/m.2 (125 pounds per square inch gage),the respirator shall be equipped with apressure-release mechanism that willprevent the pressure at the hose con-

nection from exceeding 863 kN/m.2 (125pounds per square inch gage) under anyconditions.

§ 84.149 Type C supplied-air res-pirator, demand and pressure de-mand class; minimum require-ments.

(a) Respirators tested under this sec-tion shall be approved only when usedto supply respirable air at the pres-sures and quantities required.

(b) The manufacturer shall specifythe range of air pressure at the point ofattachment of the air-supply hose tothe air-supply system, and the range ofhose length for the respirator. For ex-ample, he might specify that the res-pirator be used with compressed air atpressures ranging from 280–550 kN/m.2

(40 to 80 pounds per square inch) withfrom 6 to 76 m. (15 to 250 feet) of air-supply hose.

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563

Public Health Service, HHS § 84.152

(c) The specified air pressure at thepoint of attachment of the hose to theair-supply system shall not exceed 863kN/m.2 (125 pounds per square inchgage).

(d)(1) Where the pressure in the air-supply system exceeds 863 kN/m.2 (125pounds per square inch gage), the res-pirator shall be equipped with a pres-sure-release mechanism that will pre-vent the pressure at the point of at-tachment of the hose to the air-supplysystem from exceeding 863 kN/m.2 (125pounds per square inch gage).

(2) The pressure-release mechanismshall be set to operate at a pressure notmore than 20 percent above the manu-facturer’s highest specified pressure.For example, if the highest specifiedpressure is 863 kN/m.2 (125 pounds persquare inch), the pressure-releasemechanism would be set to operate ata maximum of 1,035 kN/m.2 (150 poundsper square inch).

§ 84.150 Air-supply line tests; minimumrequirements.

Air supply lines employed on Type A,Type B, and Type C supplied-air res-pirators shall meet the minimum testrequirements set forth in Table 8 ofthis subpart.

§ 84.151 Harness test; minimum re-quirements.

(a)(1) Shoulder straps employed onType A supplied-air respirators shall betested for strength of material, joints,and seams and must separately with-stand a pull of 113 kg. (250 pounds) for30 minutes without failure.

(2) Belts, rings, and attachments forlife lines must withstand a pull of 136kg. (300 pounds) for 30 minutes withoutfailure.

(3) The hose shall be firmly attachedto the harness so as to withstand a pullof 113 kg. (250 pounds) for 30 minuteswithout separating, and the hose at-tachments shall be arranged so thatthe pull or drag of the hose behind anadvancing wearer does not disarrangethe harness or exert pull upon the face-piece.

(4) The arrangement and suitabilityof all harness accessories and fittingswill be considered.

(b)(1) The harness employed on TypeB supplied-air respirators shall not be

uncomfortable, disturbing, or interferewith the movements of the wearer.

(2) The harness shall be easily adjust-able to various sizes.

(3) The hose shall be attached to theharness in a manner that will with-stand a pull of 45 kg. (100 pounds) for 30minutes without separating or showingsigns of failure.

(4) The design of the harness and at-tachment of the line shall permit drag-ging the maximum length of hose con-sidered for approval over a concretefloor without disarranging the harnessor exerting a pull on the facepiece.

(5) The arrangement and suitabilityof all harness accessories and fittingswill be considered.

(c) The harness employed on Type Crespirators shall be similar to that re-quired on the Type B respirator, or, itmay consist of a simple arrangementfor attaching the hose to a part of thewearer’s clothing in a practical mannerthat prevents a pull equivalent to drag-ging the maximum length of the hoseover a concrete floor from exerting pullupon the respiratory-inlet covering.

(d) Where supplied-air respiratorshave a rigid or partly rigid head cover-ing, a suitable harness shall be re-quired to assist in holding this cover-ing in place.

§ 84.152 Breathing tube test; minimumrequirements.

(a)(1) Type A and Type B supplied-airrespirators shall employ one or twoflexible breathing tubes of thenonkinking type which extend fromthe facepiece to a connecting hose cou-pling attached to the belt or harness.

(2) The breathing tubes employedshall permit free head movement, in-sure against closing off by kinking orby chin or arm pressure, and they shallnot create a pull that will loosen thefacepiece or disturb the wearer.

(b) Breathing tubes employed onType C supplied-air respirators of thecontinuous flow class shall meet theminimum requirements set forth inparagraph (a) of this section, however,an extension of the connecting hosemay be employed in lieu of the breath-ing tubes required.

(c)(1) A flexible, nonkinking typebreathing tube shall:

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42 CFR Ch. I (10–1–97 Edition)§ 84.153

(i) Be employed on Type C supplied-air respirators of the demand and pres-sure-demand class; and

(ii) Extend from the facepiece to thedemand or pressure-demand valve, ex-cept where the valve is attached di-rectly to the facepiece.

(2) The breathing tube shall permitfree head movement, insure againstclosing off by kinking or by chin orarm pressure, and shall not create apull that will loosen the facepiece ordisturb the wearer.

§ 84.153 Airflow resistance test, Type Aand Type AE supplied-air res-pirators; minimum requirements.

(a) Airflow resistance will be deter-mined when the respirator is com-pletely assembled with the respiratory-inlet covering, the air-supply device,and the maximum length of air-supplyhose coiled for one-half its length inloops 1.5 to 2.1 m. (5 to 7 feet) in diame-ter.

(b) The inhalation resistance, drawnat the rate of 85 liters (3 cubic feet) perminute when the blower is not operat-ing or under any practical condition ofblower operation shall not exceed thefollowing amounts:

Maximum length of hose forwhich respirator is approved

Maximum resistance, watercolumn height

Feet Meters Inches Millimeters

75 23 1.5 38150 46 2.5 64250 76 3.5 89300 91 4.0 102

(c) The exhalation resistance shallnot exceed 25 mm. (1 inch) of water-col-umn height at a flow rate of 85 liters (3cubic feet) per minute when the bloweris not operating or under any practicalcondition of blower operation.

§ 84.154 Airflow resistance test; Type Band Type BE supplied-air res-pirators; minimum requirements.

(a) Airflow resistance shall be deter-mined when the respirator is com-pletely assembled with the respiratory-inlet covering and the hose in the max-imum length to be considered for ap-proval, coiled in loops 1.5 to 2.1 m. (5 to7 feet) in diameter.

(b) Airflow resistance shall not ex-ceed 38 mm. (1.5 inches) of water-col-

umn height to air drawn at the flowrate of 85 liters (3 cubic feet) perminute.

(c) The exhalation resistance shallnot exceed 25 mm. (1 inch) of water-col-umn height at this flow rate.

§ 84.155 Airflow resistance test; Type Csupplied-air respirator, continuousflow class and Type CE supplied-airrespirator; minimum requirements.

The resistance to air flowing fromthe respirator shall not exceed 25 mm.(1 inch) of water-column height whenthe air flow into the respiratory-inletcovering is 115 liters (4 cubic feet) perminute.

§ 84.156 Airflow resistance test; Type Csupplied-air respirator, demandclass; minimum requirements.

(a) Inhalation resistance shall not ex-ceed 50 millimeters (2 inches) of waterat an air flow of 115 liters (4 cubic feet)per minute.

(b) The exhalation resistance to aflow of air at a rate of 85 liters (3 cubicfeet) per minute shall not exceed 25millimeters (1 inch) of water.

§ 84.157 Airflow resistance test; Type Csupplied-air respirator, pressure-demand class; minimum require-ments.

(a) The static pressure in the face-piece shall not exceed 38 mm. (1.5inches) of water-column height.

(b) The pressure in the facepieceshall not fall below atmospheric at in-halation airflows less than 115 liters (4cubic feet) per minute.

(c) The exhalation resistance to aflow of air at a rate of 85 liters (3 cubicfeet) per minute shall not exceed thestatic pressure in the facepiece bymore than 51 mm. (2 inches) of water-column height.

§ 84.158 Exhalation valve leakage test.

(a) Dry exhalation valves and valveseats will be subjected to a suction of25 mm. water-column height while in anormal operating position.

(b) Leakage between the valve andvalve seat shall not exceed 30 milli-liters per minute.

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Public Health Service, HHS § 84.163

§ 84.159 Man tests for gases and va-pors; supplied-air respirators; gen-eral performance requirements.

(a) Wearers will enter a chamber con-taining a gas or vapor as prescribed in§§ 84.160, 84.161, 84.162, and 84.163.

(b) Each wearer will spend 10 minutesin work to provide observations onfreedom of the device from leakage.The freedom and comfort allowed thewearer will also be considered.

(c) Time during the test period willbe divided as follows:

(1) Five minutes. Walking, turninghead, dipping chin; and

(2) Five minutes. Pumping air with atire pump into a 28-liter (1 cubic foot)container, or equivalent work.

(d) No odor of the test gas or vaporshall be detected by the wearer in theair breathed during any such test, andthe wearer shall not be subjected toany undue discomfort or encumbrancebecause of the fit, air delivery, or otherfeatures of the respirator during thetesting period.

§ 84.160 Man test for gases and vapors;Type A and Type AE respirators;test requirements.

(a) The completely assembled res-pirator will be worn in a chamber con-taining 0.1±0.025 percent isoamyl ace-tate vapor, and the blower, the intakeof the hose, and not more than 25 per-cent of the hose length will be locatedin isoamyl acetate-free air.

(b) The man in the isoamyl acetateatmosphere will draw his inspired airthrough the hose, connections, and allparts of the air device by means of hislungs alone (blower not operating).

(c) The 10-minute work test will berepeated with the blower in operationat any practical speed up to 50 revolu-tions of the crank per minute.

§ 84.161 Man test for gases and vapors;Type B and Type BE respirators;test requirements.

(a) The completely assembled res-pirator will be worn in a chamber con-taining 0.1±0.025 percent isoamyl ace-

tate vapor, and the intake of the hose,and not more than 25 percent of thehose length will be located in isoamylacetate-free air.

(b) The man in the isoamyl acetateatmosphere will draw his inspired airthrough the hose and connections bymeans of his lungs alone.

§ 84.162 Man test for gases and vapors;Type C respirators, continuous-flowclass and Type CE supplied-air res-pirators; test requirements.

(a) The completely assembled res-pirator will be worn in a chamber con-taining 0.1±0.025 percent isoamyl ace-tate vapor, the intake of the hose willbe connected to a suitable source ofrespirable air, and not more than 25percent of the hose length will be lo-cated in isoamyl acetate-free air.

(b) The minimum flow of air requiredto maintain a positive pressure in therespiratory-inlet covering throughoutthe entire breathing cycle will be sup-plied to the wearer, provided however,that airflow shall not be less than 115liters per minute for tight-fitting andnot less than 170 liters per minute forloose-fitting respiratory inlet-cover-ings.

(c) The test will be repeated with themaximum rate of flow attainable with-in specified operating pressures.

§ 84.163 Man test for gases and vapors;Type C supplied-air respirators, de-mand and pressure-demand classes;test requirements.

(a) The completely assembled res-pirator will be worn in a chamber con-taining 0.1±0.025 percent isoamyl ace-tate vapor, the intake of the hose willbe connected to a suitable source ofrespirable air, and not more than 25percent of the hose length will be lo-cated in isoamyl acetate-free air.

(b) The test will be conducted at theminimum pressure with the maximumhose length and will be repeated at themaximum pressure with the minimumhose length.

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TABLES TO SUBPART J OF PART 84

TABLE 8—AIR-SUPPLY-LINE REQUIREMENTS AND TESTS[42 CFR part 84, subpart J]

Specific requirementsRequirements for the air-supply lines of the indicated type of supplied-air respirators

Type A Type B Type C

Length of hose ............... Maximum of 91 m. (300feet), in multiples of7.6 m. (25 feet).

Maximum of 23 m. (75feet) in multiples of7.6 m. (25 feet).

Maximum of 91 m. (300 feet) in multiples of 7.6m. (25 feet). It will be permissible for the ap-plicant to supply hose of the approved type ofshorter length than 7.6 m. (25 feet) providedit meets the requirements of the part.

Air flow ........................... None ............................. None ............................. The air-supply hose with air regulating valve ororifice shall permit a flow of not less than 115liters (4 cubic feet) per minute to tight-fittingand 170 liters (6 cubic feet) per minute toloose-fitting respiratory-inlet coverings throughthe maximum length of hose for which ap-proval is granted and at the minimum speci-fied air-supply pressure. The maximum flowshall not exceed 425 liters (15 cubic feet) perminute at the maximum specified air-supplypressure with the minimum length of hose forwhich approval is granted.

Air flow ........................... ......do ........................... ......do ........................... The air-supply hose, detachable coupling, anddemand valve of the demand class or pres-sure-demand valve of the pressure-demandclass for Type C supplied-air respirators, de-mand and pressure-demand classes, shall becapable of delivering respirable air at a rateof not less than 115 liters (4 cubic feet) perminute to the respiratory-inlet covering at aninhalation resistance not exceeding 50 milli-meters (2 inches) of water-column heightmeasured in the respiratory-inlet coveringwith any combination of air-supply pressureand length of hose within the applicant’sspecified range of pressure and hose length.The air-flow rate and resistance to inhalationshall be measured while the demand or pres-sure-demand valve is actuated 20 times perminute by a source of intermittent suction.The maximum rate of flow to the respiratory-inlet covering shall not exceed 425 liters (15cubic feet) per minute under the specified op-erating conditions.

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Public Health Service, HHS § 84.163

TABLE 8—AIR-SUPPLY-LINE REQUIREMENTS AND TESTS—Continued[42 CFR part 84, subpart J]

Specific requirementsRequirements for the air-supply lines of the indicated type of supplied-air respirators

Type A Type B Type C

Air-regulating valve ........ ......do ........................... ......do ........................... If an air-regulating valve is provided, it shall beso designed that it will remain at a specificadjustment, which will not be affected by theordinary movement of the wearer. The valvemust be so constructed that the air supplywith the maximum length of hose and at theminimum specified air-supply pressure will notbe less than 115 liters (4 cubic feet) of air perminute to tight-fitting and 170 liters (6 cubicfeet) of air per minute of loose-fitting res-piratory inlet coverings for any adjustment ofthe valve. If a demand or pressure-demandvalve replaces the air-regulating valve, it shallbe connected to the air-supply at the maxi-mum air pressure for which approval issought by means of the minimum length ofair-supply hose for which approval is sought.The outlet of the demand or pressure-de-mand valve shall be connected to a source ofintermittent suction so that the demand orpressure-demand valve is actuated approxi-mately 20 times per minute for a total of100,000 inhalations. To expedite this test, therate of actuation may be increased if mutuallyagreeable to the applicant and NIOSH. Dur-ing this test the valve shall function withoutfailure and without excessive wear of themoving parts. The demand or pressure-de-mand valve shall not be damaged in any waywhen subjected at the outlet to a pressure orsuction of 25 cm. (10 inches) of water gagefor 2 minutes.

Noncollapsibility ............. The hose shall not col-lapse or exhibit per-manent deformationwhen a force of 90kg. (200 pounds) isapplied for 5 minutesbetween 2 planes 7.6cm. (3 inches) wideon opposite sides ofthe hose.

Same as Type A .......... None.

Nonkinkability ................. None ............................. None ............................. A 7.6 m. (25 foot) section of the hose will beplaced on a horizontal-plane surface andshaped into a one-loop coil with one end ofthe hose connected to an airflow meter andthe other end of the hose supplied with air atthe minimum specified supply pressure. Theconnection shall be in the plane of the loop.The other end of the hose will be pulled tan-gentially to the loop and in the plane of theloop until the hose straightens. To meet therequirements of this test the loop shall main-tain a uniform near-circular shape and ulti-mately unfold as a spiral, without any local-ized deformation that decreases the flow ofair to less than 90 percent of the flow whenthe hose is tested while remaining in astraight line.

Strength of hose andcouplings.

Hose and couplingsshall not separate orfail when tested witha pull of 113 kg. (250pounds) for 5 minutes.

Same as Type A .......... Hose and couplings shall not exhibit any sepa-ration or failure when tested with a pull of 45kg. (100 pounds) for 5 minutes and whentested by subjecting them to an internal airpressure of 2 times the maximum respirator-supply pressure that is specified by the appli-cant or at 173 kN/m. 2 (25 pounds per squareinch) gage, whichever is higher.

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42 CFR Ch. I (10–1–97 Edition)§ 84.170

TABLE 8—AIR-SUPPLY-LINE REQUIREMENTS AND TESTS—Continued[42 CFR part 84, subpart J]

Specific requirementsRequirements for the air-supply lines of the indicated type of supplied-air respirators

Type A Type B Type C

Tightness ....................... No air leakage shalloccur when the hoseand couplings arejoined and the joint(s)are immersed inwater and subjectedto an internal airpressure of 35 kN/m.2 (5 pounds persquare inch) gage.

None ............................. Leakage of air exceeding 50 cc. per minute ateach coupling shall not be permitted whenthe hose and couplings are joined and areimmersed in water, with air flowing throughthe respirator under a pressure of 173 kN/m.2 (25 pounds per square inch) gage appliedto the inlet end of the air-supply hose, or attwice the maximum respirator-supply pressurethat is specified by the applicant, whichever ishigher.

Permeation of hose bygasoline.

The permeation of thehose by gasoline willbe tested by immers-ing 7.6 m. (25 feet) ofhose and one cou-pling in gasoline, withair flowing throughthe hose at the rateof 8 liters per minutefor 6 hours. The airfrom the hose shallnot contain more than0.01 percent by vol-ume of gasolinevapor at the end ofthe test.

Same as for Type A ..... Same as for Type A, except the test periodshall be 1 hour.

Detachable coupling ...... None ............................. None ............................. A hand-operated detachable coupling by whichthe wearer can readily attach or detach theconnecting hose shall be provided at a con-venient location. This coupling shall be dura-ble, remain connected under all conditions ofnormal respirator use, and meet the pre-scribed tests for strength and tightness ofhose and couplings.

Subpart K—Non-Powered Air-Purifying Particulate Respirators

§ 84.170 Non-powered air-purifyingparticulate respirators; description.

(a) Non-powered air-purifying partic-ulate respirators utilize the wearer’snegative inhalation pressure to drawthe ambient air through the air-purify-ing filter elements (filters) to removeparticulates from the ambient air.They are designed for use as res-piratory protection againstatmospheres with particulate contami-nants (e.g., dusts, fumes, mists) thatare not immediately dangerous to lifeor health and that contain adequateoxygen to support life.

(b) Non-powered air-purifying partic-ulate respirators are classified intothree series, N-, R-, and P-series. TheN-series filters are restricted to use inthose workplaces free of oil aerosols.The R- and P-series filters are intended

for removal of any particulate that in-cludes oil-based liquid particulates.

(c) Non-powered air-purifying partic-ulate respirators are classified accord-ing to the efficiency level of the fil-ter(s) as tested according to the re-quirements of this part.

(1) N100, R100, and P100 filters shalldemonstrate a minimum efficiencylevel of 99.97 percent.

(2) N99, R99, and P99 filters shalldemonstrate a minimum efficiencylevel of 99 percent.

(3) N95, R95, and P95 filters shalldemonstrate a minimum efficiencylevel of 95 percent.

§ 84.171 Non-powered air-purifyingparticulate respirators; requiredcomponents.

(a) Each non-powered air-purifyingparticulate respirator described in§ 84.170 shall, where its design requires,contain the following component parts:

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Public Health Service, HHS § 84.177

(1) Facepiece, mouthpiece with nose-clip, hood, or helmet;

(2) Filter unit;(3) Harness;(4) Attached blower; and(5) Breathing tube.(b) The components of each non-pow-

ered air-purifying particulate res-pirator shall meet the minimum con-struction requirements set forth insubpart G of this part.

§ 84.172 Breathing tubes; minimum re-quirements.

Flexible breathing tubes used in con-junction with respirators shall be de-signed and constructed to prevent:

(a) Restriction of free head move-ment;

(b) Disturbance of the fit offacepieces, mouthpieces, hoods, or hel-mets;

(c) Interference with the wearer’s ac-tivities; and

(d) Shutoff of airflow due to kinking,or from chin or arm pressure.

§ 84.173 Harnesses; installation andconstruction; minimum require-ments.

(a) Each respirator shall, where nec-essary, be equipped with a suitable har-ness designed and constructed to holdthe components of the respirator in po-sition against the wearer’s body.

(b) Harnesses shall be designed andconstructed to permit easy removaland replacement of respirator parts,and, where applicable, provide for hold-ing a full facepiece in the ready posi-tion when not in use.

§ 84.174 Respirator containers; mini-mum requirements.

(a) Except as provided in paragraph(b) of this section each respirator shallbe equipped with a substantial, durablecontainer bearing markings whichshow the applicant’s name, the type ofrespirator it contains, and all appro-priate approval labels.

(b) Containers for single-use res-pirators may provide for storage ofmore than one respirator, however,such containers shall be designed andconstructed to prevent contaminationof respirators which are not removed,and to prevent damage to respiratorsduring transit.

§ 84.175 Half-mask facepieces, fullfacepieces, hoods, helmets, andmouthpieces; fit; minimum require-ments.

(a) Half-mask facepieces and fullfacepieces shall be designed and con-structed to fit persons with various fa-cial shapes and sizes either:

(1) By providing more than one face-piece size; or

(2) By providing one facepiece sizewhich will fit varying facial shapes andsizes.

(b) Full facepieces shall provide foroptional use of corrective spectacles orlenses, which shall not reduce the res-piratory protective qualities of the res-pirator.

(c) Hoods and helmets shall be de-signed and constructed to fit personswith various head sizes, provide for theoptional use of corrective spectacles orlenses, and insure against any restric-tion of movement by the wearer.

(d) Mouthpieces shall be equippedwith noseclips which are securely at-tached to the mouthpiece or respiratorand provide an airtight seal.

(e) Facepieces, hoods, and helmetsshall be designed to prevent eyepiecefogging.

(f) Half-mask facepieces shall notinterfere with the fit of common indus-trial safety corrective spectacles.

§ 84.176 Facepieces, hoods, and hel-mets; eyepieces; minimum require-ments.

Facepieces, hoods, and helmets shallbe designed and constructed to provideadequate vision which is not distortedby the eyepieces.

§ 84.177 Inhalation and exhalationvalves; minimum requirements.

(a) Inhalation and exhalation valvesshall be protected against distortion.

(b) Inhalation valves shall be de-signed and constructed and providedwhere necessary to prevent excessiveexhaled air from adversely affectingfilters, except where filters are specifi-cally designed to resist moisture.

(c) Exhalation valves shall be:(1) Provided where necessary;(2) Protected against damage and ex-

ternal influence; and

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42 CFR Ch. I (10–1–97 Edition)§ 84.178

(3) Designed and constructed to pre-vent inward leakage of contaminatedair.

§ 84.178 Head harnesses; minimum re-quirements.

(a) All facepieces shall be equippedwith head harnesses designed and con-structed to provide adequate tensionduring use and an even distribution ofpressure over the entire area in contactwith the face.

(b) Facepiece head harnesses, exceptthose employed on single-use res-pirators, shall be adjustable and re-placeable.

(c) Mouthpieces shall be equipped,where applicable, with adjustable andreplaceable harnesses, designed andconstructed to hold the mouthpiece inplace.

§ 84.179 Non-powered air-purifyingparticulate respirators; filter identi-fication.

(a) The respirator manufacturer, aspart of the application for certifi-cation, shall specify the filter seriesand the filter efficiency level (i.e.,‘‘N95’’, ‘‘R95, ‘‘P95’’, ‘‘N99, ‘‘R99’’,‘‘P99’’, ‘‘N100’’, ‘‘R100’’, or ‘‘P100’’) forwhich certification is being sought.

(b) Filters shall be prominently la-beled as follows:

(1) N100 filters shall be labeled ‘‘N100Particulate Filter (99.97% filter effi-ciency level)’’ and shall be a colorother than magenta.

(2) R100 filters shall be labeled ‘‘R100Particulate Filter (99.97% filter effi-ciency level)’’ and shall be a colorother than magenta.

(3) P100 filters shall be labeled ‘‘P100Particulate Filter (99.97% filter effi-ciency level)’’ and shall be color codedmagenta.

(4) N99 filters shall be labeled ‘‘N99Particulate Filter (99% filter efficiencylevel)’’ and shall be a color other thanmagenta.

(5) R99 filters shall be labeled ‘‘R99Particulate Filter (99% filter efficiencylevel)’’ and shall be a color other thanmagenta.

(6) P99 filters shall be labeled ‘‘P99Particulate Filter (99% filter efficiencylevel)’’ and shall be a color other thanmagenta.

(7) N95 filters shall be labeled as ‘‘N95Particulate Filter (95% filter efficiencylevel)’’ and shall be a color other thanmagenta.

(8) R95 filters shall be labeled as ‘‘R95Particulate Filter (95% filter efficiencylevel)’’ and shall be a color other thanmagenta.

(9) P95 filters shall be labeled as ‘‘P95Particulate Filter (95% filter efficiencylevel)’’ and shall be a color other thanmagenta.

§ 84.180 Airflow resistance tests.

(a) Resistance to airflow will bemeasured in the facepiece, mouthpiece,hood, or helmet of a particulate res-pirator (complete respirator) mountedon a test fixture with air flowing atcontinuous rate of 85±2 liters perminute, before each test conducted inaccordance with § 84.182.

(b) The resistances for particulaterespirators upon initial inhalationshall not exceed 35 mm water columnheight pressure and upon initial exha-lation shall not exceed 25 mm watercolumn height pressure.

§ 84.181 Non-powered air-purifyingparticulate filter efficiency level de-termination.

(a) Twenty filters of each non-pow-ered air-purifying particulate res-pirator model shall be tested for filterefficiency against:

(1) A solid sodium chloride particu-late aerosol as per this section, if N-se-ries certification is requested by theapplicant.

(2) A dioctyl phthalate or equivalentliquid particulate aerosol as per thissection, if R-series or P-series certifi-cation is requested by the applicant.

(b) Filters including holders and gas-kets; when separable, shall be testedfor filter efficiency level, as mountedon a test fixture in the manner as usedon the respirator.

(c) Prior to filter efficiency testing of20 N-series filters, the 20 to be testedshall be taken out of their packagingand placed in an environment of 85±5percent relative humidity at 38±2.5 °Cfor 25±1 hours. Following the pre-condi-tioning, filters shall be sealed in a gas-tight container and tested within 10hours.

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Public Health Service, HHS § 84.190

(d) When the filters do not have sepa-rable holders and gaskets, the exhala-tion valves shall be blocked so as to en-sure that leakage, if present, is not in-cluded in the filter efficiency levelevaluation.

(e) For non-powered air-purifyingparticulate respirators with a singlefilter, filters shall be tested at a con-tinuous airflow rate of 85±4 liters perminute. Where filters are to be used inpairs, the test-aerosol airflow rateshall be 42.5±2 liters per minutethrough each filter.

(f) Filter efficiency test aerosols.(1) When testing N-series filters, a so-

dium chloride or equivalent solid aero-sol at 25±5 °C and relative humidity of30±10 percent that has been neutralizedto the Boltzmann equilibrium stateshall be used. Each filter shall be chal-lenged with a concentration not ex-ceeding 200 mg/m3.

(2) When testing R-series and P-seriesfilters, a neat cold-nebulized dioctylphthalate (DOP) or equivalent aerosolat 25±5 °C that has been neutralized tothe Boltzmann equilibrium state shallbe used. Each filter shall be challengedwith a concentration not exceeding 200mg/m3.

(3) The test shall continue until min-imum efficiency is achieved or until anaerosol mass of at least 200±5 mg hascontacted the filter. For P-series fil-ters, if the filter efficiency is decreas-ing when the 200±5 mg challenge pointis reached, the test shall be continueduntil there is no further decrease in ef-ficiency.

(g) The sodium chloride test aerosolshall have a particle size distributionwith count median diameter of0.075±0.020 micrometer and a standardgeometric deviation not exceeding 1.86at the specified test conditions as de-termined with a scanning mobility par-ticle sizer or equivalent. The DOP aero-sol shall have a particle size distribu-tion with count median diameter of0.185±0.020 micrometer and a standardgeometric deviation not exceeding 1.60at the specified test conditions as de-termined with a scanning mobility par-ticle sizer or equivalent.

(h) The efficiency of the filter shallbe monitored and recorded throughoutthe test period by a suitable forward-

light-scattering photometer or equiva-lent instrumentation.

(i) The minimum efficiency for eachof the 20 filters shall be determined andrecorded and be equal to or greaterthan the filter efficiency criterion list-ed for each level as follows:

P100, R100 and N100: Efficiency ≥99.97%P99, R99 and N99: Efficiency ≥99%P95, R95 and N95: Efficiency ≥95%

§ 84.182 Exhalation valve leakage test;minimum requirements.

(a) Dry exhalation valves and valveseats will be subjected to a suction of25 mm. water-column height while in anormal operating position.

(b) Leakage between the valve andvalve seat shall not exceed 30 milli-liters per minute.

Subpart L—Chemical CartridgeRespirators

§ 84.190 Chemical cartridge res-pirators: description.

(a) Chemical cartridge respirators in-cluding all completely assembled res-pirators which are designed for use asrespiratory protection during entryinto or escape from atmospheres notimmediately dangerous to life andhealth, are described according to thespecific gases or vapors against whichthey are designed to provide res-piratory protection, as follows:

Type of chemical cartridge respirator 1

Maximumuse con-

centration,parts per

million

Ammonia ............................................................ 300Chlorine ............................................................. 10Hydrogen chloride ............................................. 50Methyl amine ..................................................... 100Organic vapor .................................................... 2 1,000Sulfur dioxide ..................................................... 50Vinyl chloride ..................................................... 10

1 Not for use against gases or vapors with poor warningproperties (except where MSHA or Occupational Safety andHealth Administration standards may permit such use for aspecific gas or vapor) or those which generate high heats ofreaction with sorbent material in the cartridge.

2 Maximum use concentrations are lower for organic vaporswhich produce atmospheres immediately hazardous to life orhealth at concentrations equal to or lower than thisconcentration.

(b) Chemical cartridge respirators forrespiratory protection against gases orvapors, which are not specifically list-ed with their maximum use concentra-tion, may be approved if the applicant

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42 CFR Ch. I (10–1–97 Edition)§ 84.191

submits a request for such approval, inwriting, to the Institute. The Instituteshall consider each such applicationand accept or reject the applicationafter a review of the effects on thewearer’s health and safety and in thelight of any field experience in use ofchemical cartridge respirators as pro-tection against such hazards.

§ 84.191 Chemical cartridge res-pirators; required components.

(a) Each chemical cartridge res-pirator described in § 84.190 shall, whereits design requires, contain the follow-ing component parts:

(1) Facepiece, mouthpiece, and nose-clip, hood, or helmet;

(2) Cartridge;(3) Cartridge with filter;(4) Harness;(5) Breathing tube; and(6) Attached blower.(b) The components of each chemical

cartridge respirator shall meet theminimum construction requirementsset forth in subpart G of this part.

§ 84.192 Cartridges in parallel; resist-ance requirements.

Where two or more cartridges areused in parallel, their resistance to air-flow shall be essentially equal.

§ 84.193 Cartridges; color and mark-ings; requirements.

The color and markings of all car-tridges or labels shall conform with therequirements of the American NationalStandards Institute, American Na-tional Standard for Identification ofAir-Purifying Respirator Canisters andCartridges, ANSI K13.1–1973. ANSIK13.1 is incorporated by reference andhas been approved by the Director ofthe Federal Register in accordancewith 5 U.S.C. 552(a) and 1 CFR part 51.Copies may be obtained from AmericanNational Standards Institute, Inc., 1430Broadway, New York, NY 10018. Copiesmay be inspected at the NIOSH, Cer-tification and Quality AssuranceBranch, 1095 Willowdale Road, Morgan-town, WV 26505–2888, or at the Office of

the Federal Register, 800 North CapitolStreet, NW., suite 700, Washington, DC.

§ 84.194 Filters used with chemicalcartridges; location; replacement.

(a) Particulate matter filters used inconjunction with a chemical cartridgeshall be located on the inlet side of thecartridge.

(b) Filters shall be incorporated in orfirmly attached to the cartridge andeach filter assembly shall, where appli-cable, be designed to permit its easy re-moval from and replacement on thecartridge.

§ 84.195 Breathing tubes; minimum re-quirements.

Flexible breathing tubes used in con-junction with respirators shall be de-signed and constructed to prevent:

(a) Restriction of free head move-ment;

(b) Disturbance of the fit offacepieces, mouthpieces, hoods, or hel-mets;

(c) Interference with the wearer’s ac-tivities; and

(d) Shutoff of airflow due to kinking,or from chin or arm pressure.

§ 84.196 Harnesses; installation andconstruction; minimum require-ments.

(a) Each respirator shall, where nec-essary, be equipped with a suitable har-ness designed and constructed to holdthe components of the respirator in po-sition against the wearer’s body.

(b) Harnesses shall be designed andconstructed to permit easy removaland replacement of respirator partsand, where applicable, provide for hold-ing a full facepiece in the ready posi-tion when not in use.

§ 84.197 Respirator containers; mini-mum requirements.

Respirators shall be equipped with asubstantial, durable container bearingmarkings which show the applicant’sname, the type and commercial des-ignation of the respirator it containsand all appropriate approval labels.

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Public Health Service, HHS § 84.203

§ 84.198 Half-mask facepieces, fullfacepieces, mouthpieces, hoods, andhelmets; fit; minimum require-ments.

(a) Half-mask facepieces and fullfacepieces shall be designed and con-structed to fit persons with various fa-cial shapes and sizes either:

(1) By providing more than one face-piece size; or

(2) By providing one facepiece sizewhich will fit varying facial shapes andsizes.

(b) Hoods and helmets shall be de-signed and constructed to fit personswith various head sizes, provide for theoptional use of corrective spectacles orlenses, and insure against any restric-tion of movement by the wearer.

(c) Mouthpieces shall be equippedwith noseclips which are securely at-tached to the mouthpiece or respiratorand provide an airtight fit.

(d) Full facepieces shall provide foroptional use of corrective spectacles orlenses which shall not reduce the res-piratory protective qualities of the res-pirator.

(e) Facepieces, hoods, and helmetsshall be designed to prevent eyepiecefogging.

§ 84.199 Facepieces, hoods, and hel-mets; eyepieces; minimum require-ments.

Facepieces, hoods, and helmets shallbe designed and constructed to provideadequate vision which is not distortedby the eyepieces.

§ 84.200 Inhalation and exhalationvalves; minimum requirements.

(a) Inhalation and exhalation valvesshall be provided where necessary andprotected against distortion.

(b) Inhalation valves shall be de-signed and constructed to prevent ex-cessive exhaled air from entering car-tridges or adversely affecting canisters.

(c) Exhalation valves shall be—

(1) Protected against damage and ex-ternal influence; and

(2) Designed and constructed to pre-vent inward leakage of contaminatedair.

§ 84.201 Head harnesses; minimum re-quirements.

(a) (1) Facepieces for chemical car-tridge respirators other than single-usevinyl chloride shall be equipped withadjustable and replaceable head har-nesses designed and constructed to pro-vide adequate tension during use andan even distribution of pressure overthe entire area in contact with theface.

(2) Facepieces for single-use vinylchloride respirators shall be equippedwith adjustable head harnesses de-signed and constructed to provide ade-quate tension during use and an evendistribution of pressure over the entirearea in contact with the face.

(b) Mouthpieces shall be equippedwhere applicable, with an adjustableand replaceable harness designed andconstructed to hold the mouthpiece inplace.

§ 84.202 Air velocity and noise levels;hoods and helmets; minimum re-quirements.

Noise levels generated by the res-pirator will be measured inside thehood or helmet at maximum airflowobtainable and shall not exceed 80 dBA.

§ 84.203 Breathing resistance test; min-imum requirements.

(a) Resistance to airflow will bemeasured in the facepiece, mouthpiece,hood, or helmet of a chemical cartridgerespirator mounted on a test fixturewith air flowing at a continuous rate of85 liters per minute, both before andafter each test conducted in accordancewith §§ 84.206 through 84.207.

(b) The maximum allowable resist-ance requirements for chemical car-tridge respirators are as follows:

MAXIMUM RESISTANCE[Millimeter water column height]

Type of chemical-cartridge respiratorInhalation

ExhalationInitial Final1

Other than single-use vinyl chloride respirators:For gases, vapors, or gases and vapors ............................................................... 40 45 20

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42 CFR Ch. I (10–1–97 Edition)§ 84.204

MAXIMUM RESISTANCE—Continued[Millimeter water column height]

Type of chemical-cartridge respiratorInhalation

ExhalationInitial Final1

For gases, vapors, or gases and vapors, and particulates ................................... 50 70 20Single-use respirator with valves:

For vinyl chloride .................................................................................................... 20 25 20For vinyl chloride and particulates ......................................................................... 30 45 2

Single-use respirator without valves:For vinyl chloride .................................................................................................... 15 20 (2)For vinyl chloride and particulates ......................................................................... 25 40 (2)

1 Measured at end of service life specified in Table 11 of this subpart.2 Same as inhalation.

§ 84.204 Exhalation valve leakage test;minimum requirements.

(a) Dry exhalation valves and valveseats will be subjected to a suction of25 mm. water-column height while in anormal operating position.

(b) Leakage between the valve andvalve seat shall not exceed 30 milli-liters per minute.

§ 84.205 Facepiece test; minimum re-quirements.

(a) The complete chemical cartridgerespirator will be fitted to the faces ofpersons having varying facial shapesand sizes.

(b) Where the applicant specifies afacepiece size or sizes for the respiratortogether with the approximate meas-urement of faces they are designed tofit, the Institute will provide test sub-jects to suit such facial measurements.

(c) Any chemical cartridge respiratorpart which must be removed to performthe facepiece or mouthpiece fit testshall be replaceable without specialtools and without disturbing facepieceor mouthpiece fit.

(d) The facepiece or mouthpiece fittest using the positive or negativepressure recommended by the applicantand described in his instructions willbe used before each test.

(e) (1) Each wearer will enter a cham-ber containing 100 p.p.m. isoamyl ace-tate vapor for half-mask facepieces,and 1,000 p.p.m. for full facepieces,mouthpieces, hoods, and helmets.

(2) The facepiece or mouthpiece maybe adjusted, if necessary, in the testchamber before starting the test.

(3) Each wearer will remain in thechamber for 8 minutes while perform-ing the following activities:

(i) Two minutes, nodding and turninghead;

(ii) Two minutes, calisthenic armmovements;

(iii) Two minutes, running in place;and

(iv) Two minutes, pumping with atire pump into a 28-liter (1 cubic-foot)container.

(4) Each wearer shall not detect theodor of isoamyl-acetate vapor duringthe test.

§ 84.206 Particulate tests; respiratorswith filters; minimum require-ments; general.

(a) Three respirators with cartridgescontaining, or having attached tothem, filters for protection againstparticulates will be tested in accord-ance with the provisions of § 84.207.

(b) In addition to the test require-ments set forth in paragraph (a) of thissection, three such respirators will betested, as appropriate, in accordancewith the provisions of §§ 84.179 through84.183; however, the maximum allow-able resistance of complete particulate,and gas, vapor, or gas and vapor chemi-cal cartridge respirators shall not ex-ceed the maximum allowable limits setforth in § 84.203.

§ 84.207 Bench tests; gas and vaportests; minimum requirements; gen-eral.

(a) Bench tests will be made on anapparatus that allows the test atmos-phere at 50±5 percent relative humidityand room temperature, approximately25 °C, to enter the cartridges continu-ously at predetermined concentrationsand rates of flow, and that has means

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Public Health Service, HHS § 84.250

for determining the test life of the car-tridges.

(b) Where two cartridges are used inparallel on a chemical cartridge res-pirator, the bench test will be per-formed with the cartridges arranged inparallel, and the test requirements willapply to the combination rather thanto the individual cartridges.

(c) Three cartridges or pairs of car-tridges will be removed from contain-ers and tested as received from the ap-plicant.

(d) Two air purifying cartridges orpairs of cartridges will be equilibratedat room temperature by passing 25 per-

cent relative humidity air throughthem at the flow rate of 25 liters perminute (l.p.m.) for 6 hours.

(e) Two air purifying cartridges orpairs of cartridges will be equilibratedby passing 85 percent relative humidityair through them at the flow rate of 25l.p.m.

(f) All cartridges will be resealed,kept in an upright position, at roomtemperatures, and tested within 18hours.

(g) Cartridges will be tested and shallmeet the minimum requirements setforth in Table 11 of this subpart.

TABLES TO SUBPART L OF PART 84

TABLES 9 AND 10 [RESERVED]TABLE 11–CARTRIDGE BENCH TESTS AND REQUIREMENTS

[42 CFR part 84, subpart L]

Cartridge Test condition

Test atmosphereFlowrate(l.p.m.)

Number oftests

Penetra-tion 1

(p.p.m.)

Minimumlife 2 (min.)Gas or vapor Concentra-

tion (p.p.m.)

Ammonia ............ As received ........ NH3 1000 64 3 50 50Ammonia ............ Equilibrated ........ NH3 1000 32 4 50 50Chlorine ............. As received ........ Cl2 500 64 3 5 35Chlorine ............. Equilibrated ........ Cl2 500 32 4 5 35Hydrogen chlo-

ride.As received ........ HCl 500 64 3 5 50

Hydrogen chlo-ride.

Equilibrated ........ HCl 500 32 4 5 50

Methylamine ...... As received ........ CH3 NH2 1000 64 3 10 25Methylamine ...... Equilibrated ........ CH3 NH2 1000 32 4 10 25Organic vapors .. As received ........ CCl4 1000 64 3 5 50Organic vapors .. Equilibrated ........ CCl4 1000 32 4 5 50Sulfur dioxide ..... As received ........ SO2 500 64 3 5 30Sulfur dioxide ..... Equilibrated ........ SO2 500 32 4 5 30

1 Minimum life will be determined at the indicated penetration.2 Where a respirator is designed for respiratory protection against more than one type of gas or vapor, as for use in ammonia

and in chlorine, the minimum life shall be one-half that shown for each type of gas or vapor. Where a respirator is designed forrespiratory protection against more than one gas of a type, as for use in chlorine and sulfur dioxide, the stated minimal life shallapply.

Subpart M [Reserved]

Subpart N—Special UseRespirators

§ 84.250 Vinyl chloride respirators; de-scription.

Vinyl chloride respirators, includingall completely assembled respiratorswhich are designed for use as res-piratory protection during entry intoand escape from vinyl chlorideatmospheres containing adequate oxy-gen to support life, are described ac-

cording to their construction as fol-lows:

(a) Front-mounted or back-mountedgas masks;

(b) Chin-style gas masks;(c) Chemical-cartridge respirators;(d) Powered air-purifying respirators;

and(e) Other devices, including combina-

tion respirators.

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42 CFR Ch. I (10–1–97 Edition)§ 84.251

§ 84.251 Required components.(a) Each vinyl chloride respirator de-

scribed in § 84.250 shall, where its de-sign requires, contain the followingcomponent parts:

(1) Facepiece;(2) Canister with end-of-service-life

indicator;(3) Cartridge with end-of-service-life

indicator;(4) Harness;(5) Attached blower; and(6) Breathing tube.(b) The components of each vinyl

chloride respirator shall meet the min-imum construction requirements setforth in Subpart G of this part.

§ 84.252 Gas masks; requirements andtests.

(a) Except for the tests prescribed in§ 84.126, the minimum requirements andperformance tests for gas masks, pre-scribed in Subpart I of this part, areapplicable to vinyl chloride gas masks.

(b) The following bench tests are ap-plicable to canisters designed for usewith gas masks for entry into and es-cape from vinyl chloride atmospherescontaining adequate oxygen to supportlife:

(1) Four canisters will be equilibratedat 25±5 °C by passing 85±5 percent rel-ative humidity air through them at 64liters per minute for six hours.

(2) The equilibrated canisters will beresealed, kept in an upright position atroom temperature, and tested accord-ing to paragraph (b)(3) of this sectionwithin 18 hours.

(3) The canisters equilibrated andstored as described in paragraphs (b) (1)and (2) of this section will be tested onan apparatus that allows the test at-mosphere at 85±5 percent relative hu-midity and 25±5 °C to enter the canistercontinuously at a concentration of 25ppm vinyl chloride monomer at a totalflow rate of 64 liters per minute.

(4) The maximum allowable penetra-tion after six hours of testing accord-ing to paragraph (b)(3) of this sectionshall not exceed 1 ppm vinyl chloride.

(c) Where canisters are submitted fortesting and approval with a service lifeof more than four hours, the period oftime for testing for vinyl chloride pen-etration will be performed at 150% ofthe service life specified in the manu-

facturer’s application. (Example: If amanufacturer requests approval of arespirator for six hours use against ex-posure to vinyl chloride, the maximumallowable penetration after nine hoursof testing shall not exceed 1 ppm vinylchloride.)

§ 84.253 Chemical-cartridge res-pirators; requirements and tests.

(a) Except for the tests prescribed in§§ 84.206 and 84.207, the minimum re-quirements and performance tests forchemical-cartridge respirators pre-scribed in Subpart L of this part areapplicable to replaceable-cartridge andsingle-use vinyl chloride chemical-car-tridge respirators.

(b) The following bench tests are ap-plicable to cartridges designed for usewith chemical-cartridge respirators forentry into and escape from vinyl chlo-ride atmospheres containing adequateoxygen to support life:

(1) Where two cartridges are used inparallel on a chemical-cartridge res-pirator, the bench test requirementswill apply to the combination ratherthan the individual cartridges.

(2) Four cartridges or pairs of car-tridges will be equilibrated at 25±5 °Cby passing 85±5 percent relative humid-ity air through them at 25 liters perminute for six hours.

(3) The equilibrated cartridges will beresealed, kept in an upright position,at room temperature, and tested ac-cording to paragraphs (b)(4) and (b)(5)of this section for other than single-userespirators or according to paragraphs(b)(6) and (b)(7) of this section for sin-gle-use respirators within 18 hours.

(4) The cartridges or pairs of car-tridges for other than single-use res-pirators, equilibrated and stored as de-scribed in paragraphs (b)(1), (b)(2), and(b)(3) of this section, will be tested onan apparatus that allows the test at-mosphere at 85±5 percent relative hu-midity and 25±5 °C, to enter the car-tridges or pairs of cartridges continu-ously at a concentration of 10 ppmvinyl chloride monomer at a totalflowrate of 64 liters per minute.

(5) The maximum allowable penetra-tion after 90 minutes testing of car-tridges or pairs of cartridges for otherthan single-use respirators, according

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Public Health Service, HHS § 84.256

to paragraph (b)(4) of this section shallnot exceed 1 ppm vinyl chloride.

(6) The single-use respirators, equili-brated and stored as described in para-graphs (b)(2) and (b)(3) of this section,will be tested on an apparatus that al-lows a test atmosphere at 85±5 percentrelative humidity and 25±5 °C to be cy-cled through the respirator by abreathing machine at a concentrationof 10 ppm vinyl chloride monomer atthe rate of 24 respirations per minuteat a minute volume of 40±0.6 liters. Airexhaled through the respirator will be35±2 °C with 94±3 percent relative hu-midity.

(7) The maximum allowable penetra-tion after 144 minutes testing of res-pirators, according to paragraph (b)(6)of this section, shall not exceed 1 ppmvinyl chloride.

§ 84.254 Powered air-purifying res-pirators; requirements and tests.

(a) Except for the tests prescribed in§ 84.207, the minimum requirements andperformance tests for powered air-puri-fying respirators prescribed in subpartL of this part are applicable to vinylchloride powered air-purifying res-pirators.

(b) The following bench tests are ap-plicable to cartridges designed for usewith powered air-purifying respiratorsfor entry into and escape from vinylchloride atmospheres containing ade-quate oxygen to support life:

(1) Four cartridges will be equili-brated at 25± °C by passing 85±5 percentrelative humidity air through them at115 liters per minute for tight-fittingfacepieces and 170 liters per minute forloose-fitting hoods and helmets, for sixhours.

(2) The equilibrated cartridges will beresealed, kept in an upright position atroom temperature and tested accordingto paragraph (b)(3) of this section with-in 18 hours.

(3) The cartridges equilibrated andstored as described in paragraphs (b) (1)and (2) of this section will be tested onan apparatus that allows the test at-mosphere at 85±5 percent relative hu-midity and 25±5 °C to enter the car-tridge continuously at a concentrationof 25 ppm vinyl chloride monomer at atotal flow rate of 115 liters per minutefor tight-fitting facepieces and 170 li-

ters per minute for loose-fitting hoodsand helmets.

(4) The maximum allowable penetra-tion after six hours of testing accord-ing to paragraph (b)(3) of this sectionshall not exceed 1 ppm vinyl chloride.

§ 84.255 Requirements for end-of-serv-ice-life indicator.

(a) Each canister or cartridge sub-mitted for testing and approval in ac-cordance with §§ 84.252, 84.253, and 84.254shall be equipped with a canister orcartridge end-of-service-life indicatorwhich shows a satisfactory indicatorchange or other obvious warning before1 ppm vinyl chloride penetration oc-curs. The indicator shall show suchchange or afford such warning at 80±10percent of the total service life to 1ppm leakage, as determined by con-tinuing each test described in§§ 84.252(b), 84.253(b), and 84.254(b) untila 1 ppm leakage of vinyl chloride oc-curs.

(b) The applicant shall provide suffi-cient pretest data to verify the per-formance of the end-of-service-life indi-cator required in paragraph (a) of thissection.

§ 84.256 Quality control requirements.

(a) In addition to the constructionand performance requirements speci-fied in §§ 84.251, 84.252, 84.253, 84.254, and84.255, the quality control requirementsin paragraphs (b), (c), and (d) of thissection apply to approval of gas masks,chemical cartridge respirators, andpowered air-purifying respirators forentry into and escape from vinyl chlo-ride atmospheres containing adequateoxygen to support life.

(b) The respirators submitted for ap-proval as described in paragraph (a) ofthis section shall be accompanied by acomplete quality control plan meetingthe requirements of subpart E of thispart.

(c) (1) The applicant shall specify inthe plan that a sufficient number ofsamples will be drawn from each bulkcontainer of sorbent material and thatwhere activated carbon is used, the fol-lowing specific tests will be performed:

(i) Apparent density;(ii) Iodine number;(iii) Moisture content;

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42 CFR Ch. I (10–1–97 Edition)§ 84.257

(iv) Carbon tetrachloride number;and

(v) Mesh size.(2) The tests in paragraph (c)(1) of

this section shall be performed in aquantity necessary to assure continuedsatisfactory conformance of the can-isters and cartridges to the require-ments of this subpart.

(d) Final performance quality controltests on the complete canisters andcartridges shall be accomplished usingthe bench tests and procedures pre-scribed in §§ 84.252, 84.253, 84.254, and84.255.

§ 84.257 Labeling requirements.(a) A warning shall be placed on the

label of each gas mask, chemical-car-tridge respirator, and powered air-puri-fying respirator, and on the label ofeach canister and cartridge, alertingthe wearer to the need for a fitting testin accordance with the manufacturer’sfacepiece fitting instructions, provid-ing service life information, providingspecific instructions for disposal, andadvising that the wearer may commu-nicate to NIOSH any difficulties thatmay be experienced in the design andperformance of any gas mask, chemi-cal-cartridge respirator, or poweredair-purifying respirator approved underthe requirements of this subpart. Theservice lives of respirators meeting thetest requirements of this subpart shallbe specified as follows:

Chemical-cartridge respirator .............1 hour.Gas mask............................................4 hours.Powered air-purifying respirator .......4 hours.

(b) Where the service life of a res-pirator is approved for more than fourhours, the service life for which therespirator has been approved will bespecified.

§ 84.258 Fees.The following fees shall be charged

for the examination, inspection, andtesting of complete assemblies andcomponents of respirators described in§§ 84.250 and 84.251:

Complete gas mask ................................$1,100Complete chemical-cartridge res-

pirator.............................................. 1,150Complete powered air-purifying res-

pirator.............................................. 1,500Canister or cartridge only ...................... 750

Subparts O—JJ [Reserved]

Subpart KK—Dust, Fume, and Mist;Pesticide; Paint Spray; Pow-ered Air-Purifying High Effi-ciency Respirators and Com-bination Gas Masks

§ 84.1100 Scope and effective dates.The purpose of this subpart KK is to

establish procedures and requirementsfor issuing extensions of approval ofparticulate respirators certified priorto July 10, 1995 under the provisions of30 CFR part 11 (See 30 CFR part 11 edi-tion, as revised July 1, 1994.), new ap-provals and extensions of approval ofparticulate respirators for applicationsthat are in NIOSH receipt on July 10,1995, and approval of powered air-puri-fying respirators.

(a) Air-purifying respirators withparticulate filters approved under theprovisions of this subpart after July 10,1995 will have a 30 CFR part 11 approvallabel.

(b) Only changes or modifications ofnon-powered air-purifying respiratorswith particulate filters approved underthe provisions of subparts I, K, L, or Mof 30 CFR part 11 or paragraph (a) ofthis section and deemed necessary byNIOSH to ensure the health and safetyof the wearer will be approved untilJuly 10, 1998 and will have a 30 CFRpart 11 approval label.

(c) Only changes or modifications ofpowered air-purifying respirators withparticulate filters approved under theprovisions of subparts I, K, L, or M of30 CFR part 11 or paragraph (a) of thissection and deemed necessary byNIOSH to ensure the health and safetyof the wearer will be approved underthis subpart until July 10, 1998 and willhave a 30 CFR part 11 label.

(d) Approval of powered air-purifyingrespirators will be issued under thissubpart. Particulate filters for poweredair-purifying respirators approvedunder the provisions of this subpartshall be only high-efficiency (HEPA) asdescribed in § 84.1130(a)(4) and willcarry a 42 CFR part 84 approval label.In addition, changes or modificationsof powered HEPA air-purifying res-pirators approved under the provisionsof this subpart KK will be approved

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Public Health Service, HHS § 84.1103

under this subpart and will have a 42CFR part 84 approval label.

§ 84.1101 Definitions.As used in this subpart(a) Air Contamination Level means the

standards of contaminant levels pre-scribed by the Secretary of Labor inaccordance with the provisions of theOccupational Safety and Health Act of1970 (Pub. L. 91–596; 84 Stat. 1590).

(b) DOP means a homogenous liquidaerosol, having a particle diameter of0.3 micrometer, which is generated byvaporization and condensation ofdioctyl phthalate.

(c) Pesticide means:(1) Any substance or mixture of sub-

stances (including solvents and impuri-ties) intended to prevent, destroy,repel, or mitigate any insect, rodent,nematode, fungus, weed, or other formof plant or animal life or virus; and

(2) Any substance or mixture of sub-stances (including solvents and impuri-ties) intended for use as a plant regu-lator, defoliant, or desiccant, as de-fined in the Federal Insecticide, Fun-gicide, and Rodenticide Act of 1947, asamended (7 U.S.C. 135–135k), excludingfumigants which are applied as gases orvapors or in a solid or liquid form aspellets or poured liquids for subsequentrelease as gases or vapors.

(d) Radionuclide means an atom iden-tified by the constitution of its nucleus(specified by the number of protons Z,number of neutrons N, and energy, or,alternatively, by the atomic number Z,mass number A=(N+Z), and atomicmass) which exists for a measurabletime; decays or disintegrates spontane-ously, emits radiation, and results inthe formation of new nuclides.

(e) Smoke means the products of in-complete combustion of organic sub-stances in the form of solid and liquidparticles and gaseous products in air,usually of sufficient concentration toperceptibility obscure vision.

§ 84.1102 Examination, inspection andtesting of complete respirator as-semblies; fees.

The following fees shall be chargedby the Institute for the examination,inspection and testing of complete res-pirator assemblies approved under thissubpart:

(a) Gas masks with particulate filter,including pesticide gas masks—

(1) Single hazard—$1,100.(2) Type N—$4,100.(b) Dust, fume and mist respirators—(1) Single particulate hazard having

an Air Contamination Level more than0.05 mg./m.3 or 2 million particles percubic foot—$500.

(2) Combination particulate hazardshaving an Air Contamination Levelmore than 0.05 mg./m.3 or 2 million par-ticles per cubic foot—$750.

(3) Particulate hazards having an AirContamination Level less than 0.05mg./m.3 or 2 million particles per cubicfoot, radon daughters —$1,250.

(4) All dusts, fumes and mists—$2,000.(c) Paint spray respirators—$1,600.(d) Pesticide respirators—$1,600.(e) Chemical cartridge respirators

with particulate filter—$1,150.

§ 84.1103 Approval labels and mark-ings; approval of contents; use.

(a) Full-scale reproductions of ap-proval labels and markings, and asketch or description of the method ofapplication and position on the har-ness, container, canister, cartridge, fil-ter, or other component, together withinstructions for the use and mainte-nance of the respirator shall be submit-ted to MSHA and the Institute for ap-proval.

(b) Approval labels for non-poweredand powered air-purifying dust, fume,mist respirators approved prior to July10, 1995 under the provisions of subpartK of 30 CFR part 11 (See 30 CFR Part 11edition, revised as of July 1, 1994.) shallbear the emblem of the Mine Safetyand Health Administration and theseal of the Department of Health andHuman Services, the applicant’s nameand address, an approval number as-signed by the Institute, a statementthat the respirator was tested and ap-proved under subpart K of 30 CFR part11 and, where appropriate, restrictionsor limitations placed upon the use ofthe respirator by the Institute. The ap-proval number assigned by the Insti-tute shall be designated by the prefixTC and a serial number.

(c) Approval labels for powered air-purifying respirators approved underthe provisions of this subpart shall

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42 CFR Ch. I (10–1–97 Edition)§ 84.1130

bear the emblem of the National Insti-tute for Occupational Safety andHealth and the seal of the Departmentof Health and Human Services, the ap-plicant’s name and address, an ap-proval number assigned by the Insti-tute, a statement stating the res-pirator was tested under the provisionsof this subpart, and, where appropriate,restrictions or limitations placed uponthe use of the respirator by the Insti-tute. The approval number assigned bythe Institute shall be designated by theprefix TC and a serial number.

(c) The Institute shall, where nec-essary, notify the applicant when addi-tional labels, markings, or instructionswill be required.

(d) Approval labels and markingsshall only be used by the applicant towhom they were issued.

(e) Legible reproductions or abbre-viated forms of the label approved bythe Institute for use on each respiratorshall be attached to or printed at thefollowing locations:

Respirator type Label type Location

Gas mask with a particulate filter, including pes-ticide gas mask.

Entire ............................. Mask and container.

Dust, fume, and mist respirators ............................ Entire ............................. Respirator container and filter container.Abbreviated ................... Filters.

Chemical-cartridge respirator with a particulate fil-ter, including paint spray respirator.

Entire ............................. Respirator container, cartridge container, and fil-ter containers (where applicable).

Abbreviated ................... Cartridges and filters and filter containers.Pesticide respirator ................................................. Entire ............................. Respirator container, and cartridge and filter

containers.Abbreviated ................... Cartridges and filters.

(f) The use of any MSHA and Insti-tute approval label obligates the appli-cant to whom it is issued to maintainor cause to be maintained the approvedquality control sampling schedule andthe acceptable quality level for eachcharacteristic tested, and to assurethat it is manufactured according tothe drawings and specifications uponwhich the certificate of approval isbased.

(g) Each respirator, respirator com-ponent, and respirator container shall,as required by the Institute to assurequality control and proper use of therespirator, be labeled distinctly toshow the name of the applicant, andthe name and letters or numbers bywhich the respirator or respirator com-ponent is designated for trade pur-poses, and the lot number, serial num-ber, or approximate date of manufac-ture.

§ 84.1130 Respirators; description.

(a) Dust, fume, and mist respirators,including all completely assembled res-pirators designed for use as respiratoryprotection during entry into and es-cape from atmospheres which containadequate oxygen to support life and

hazardous particulates, are describedas follows:

(1) Air-purifying respirators, eitherwith replaceable or reusable filters, de-signed as respiratory protectionagainst dusts:

(i) Having an air contamination levelnot less than 0.05 milligram per cubicmeter of air, including but not limitedto coal, arsenic, cadmium, chromium,lead, and manganese; or

(ii) Having an air contaminationlevel not less than 2 million particlesper cubic foot of air, including but notlimited to aluminum, flour, iron ore,and free silica, resulting principallyfrom the disintegration of a solid, e.g.,dust clouds produced in mining, quar-rying, and tunneling, and in dusts pro-duced during industrial operations,such as grinding, crushing, and thegeneral processing of minerals andother materials.

(2) Air-purifying respirators, with re-placeable filters, designed as res-piratory protection against fumes ofvarious metals having an air contami-nation level not less than 0.05 milli-gram per cubic meter, including butnot limited to aluminum, antimony,arsenic, cadmium, chromium, copper,iron, lead, magnesium, manganese,mercury (except mercury vapor), and

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zinc, which result from the sublimationor condensation of their respective va-pors, or from the chemical reaction be-tween their respective vapors andgases.

(3) Air-purifying respirators, with re-placeable filters, designed as res-piratory protection against mists ofmaterials having an air contaminationlevel not less than 0.05 milligram percubic meter or 2 million particles percubic foot, e.g., mists produced byspray coating with vitreous enamels,chromic acid mist produced duringchromium plating, and other mists ofmaterials whose liquid vehicle does notproduce harmful gases or vapors.

(4) Air-purifying respirators, with re-placeable filters, designed as res-piratory protection against dusts,fumes, and mists having an air con-tamination level less than 0.05 milli-gram per cubic meter, including butnot limited to lithium hydride and be-ryllium, and against radionuclides.

(5) Air-purifying respirators, with re-placeable filters, designed as res-piratory protection against radondaughters, and radon daughters at-tached to dusts, fumes, and mists.

(6) Air-purifying respirators, with re-placeable filters, designed as res-piratory protection against asbestos-containing dusts and mists.

(7) Air-purifying respirators, with re-placeable filters, designed as protec-tion against various combinations ofparticulate matter.

(8) Air-purifying dust respirators de-signed as respiratory protectionagainst pneumoconiosis- and fibrosis-producing dusts, or dusts and mists, in-cluding but not limited to aluminum,asbestos, coal, flour, iron ore, and freesilica.

(b) Gas masks containing filters forprotection against dusts, fumes, mists,and smokes in combination with gases,vapors, or gases and vapors. These res-pirators are not for use against gasesor vapors with poor warning properties(except where MSHA or OccupationalSafety and Health Administrationstandards may permit such use for aspecific gas or vapor) or those whichgenerate high heats of reaction withsorbent material in the canister.

(c) Pesticide respirators, includingall completely assembled respirators

which are designed for use as res-piratory protection during entry intoand escape from atmospheres whichcontain pesticide hazards, are de-scribed according to their constructionas follows:

(1) Front-mounted or back-mountedgas masks;

(2) Chin-style gas mask;(3) Chemical cartridge;(4) Air-purifying respirator with at-

tached blower; and,(5) Other devices, including combina-

tion respirators.(d) Respirators with cartridges con-

taining or having attached to them, fil-ters for protection against mists ofpaints, lacquers, and enamels. Theserespirators are not for use againstgases or vapors with poor warningproperties (except where MSHA or Oc-cupational Safety and Health Adminis-tration standards may permit such usefor a specific gas or vapor) or thosewhich generate high heats of reactionwith sorbent material in the cartridge.

(e) Respirators with cartridges con-taining or having attached to them fil-ters for protection against dusts,fumes, and mists, except the mists ofpaints, lacquers, and enamels. Theserespirators are not for use againstgases or vapors with poor warningproperties (except where MSHA or Oc-cupational Safety and Health Adminis-tration standards may permit such usefor a specific gas or vapor) or thosewhich generate high heats of reactionwith sorbent material in the cartridge.

§ 84.1131 Respirators; required compo-nents.

(a) Each respirator described in§ 84.1130 shall, where its design re-quires, contain the following compo-nent parts:

(1) Facepiece, mouthpiece with nose-clip, hood, or helmet;

(2) Filter unit, canister with filter, orcartridge with filter;

(3) Harness;(4) Attached blower; and(5) Breathing tube.(b) The components of each res-

pirator shall meet the minimum con-struction requirements set forth inSubpart G of this part.

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§ 84.1132 Breathing tubes; minimumrequirements.

(a) Flexible breathing tubes used inconjunction with respirators shall bedesigned and constructed to prevent:

(1) Restriction of free head move-ment;

(2) Disturbance of the fit offacepieces, mouthpieces, hoods, or hel-mets;

(3) Interference with the wearer’s ac-tivities; and

(4) Shutoff of airflow due to kinking,or from chin or arm pressure.

§ 84.1133 Harnesses; installation andconstruction; minimum require-ments.

(a) Each respirator shall, where nec-essary, be equipped with a suitable har-ness designed and constructed to holdthe components of the respirator in po-sition against the wearer’s body.

(b) Harnesses shall be designed andconstructed to permit easy removaland replacement of respirator parts,and, where applicable, provide for hold-ing a full facepiece in the ready posi-tion when not in use.

§ 84.1134 Respirator containers; mini-mum requirements.

(a) Except as provided in paragraph(b) of this section each respirator shallbe equipped with a substantial, durablecontainer bearing markings whichshow the applicant’s name, the type ofrespirator it contains, and all appro-priate approval labels. Except for dust,fume, and mist respirators, the com-mercial designation of the respirator itcontains shall be shown.

(b) Containers for single-use res-pirators may provide for storage ofmore than one respirator, however,such containers shall be designed andconstructed to prevent contaminationof respirators which are not removed,and to prevent damage to respiratorsduring transit.

(c) Containers for gas masks com-binations shall be designed and con-structed to permit easy removal of themask.

§ 84.1135 Half-mask facepieces, fullfacepieces, hoods, helmets, andmouthpieces; fit; minimum require-ments.

(a) Half-mask facepieces and fullfacepieces shall be designed and con-structed to fit persons with various fa-cial shapes and sizes either:

(1) By providing more than one face-piece size; or

(2) By providing one facepiece sizewhich will fit varying facial shapes andsizes.

(b) Full facepieces shall provide foroptional use of corrective spectacles orlenses, which shall not reduce the res-piratory protective qualities of the res-pirator.

(c) Hoods and helmets shall be de-signed and constructed to fit personswith various head sizes, provide for theoptional use of corrective spectacles orlenses, and insure against any restric-tion of movement by the wearer.

(d) Mouthpieces shall be equippedwith noseclips which are securely at-tached to the mouthpiece or respiratorand provide an airtight seal.

(e) Facepieces, hoods, and helmetsshall be designed to prevent eyepiecefogging.

(f) Half-mask facepieces shall notinterfere with the fit of common indus-trial safety corrective spectacles, asdetermined by the Institute’s facepiecetests in §§ 84.1141, 84.1142, and 84.1156(b).

§ 84.1136 Facepieces, hoods, and hel-mets; eyepieces; minimum require-ments.

(a) Facepieces, hoods, and helmetsshall be designed and constructed toprovide adequate vision which is notdistorted by the eyepieces.

(b) All eyepieces of gas masks com-binations shall be designed and con-structed to be impact and penetrationresistant. Federal Specification, Mask,Air Line: and Respirator, Air Filtering,Industrial, GGG–M–125d, October 11,1965, with interim amendment-1, July30, 1969, is an example of an appropriatestandard for determining impact andpenetration resistance. Copies of GGG–M–125d may be obtained from the

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NIOSH, Certification and Quality As-surance Branch, 1095 Willowdale Road,Morgantown, WV 26505–2888.

§ 84.1137 Inhalation and exhalationvalves; minimum requirements.

(a) Inhalation and exhalation valvesshall be protected against distortion.

(b) Inhalation valves shall be de-signed and constructed and providedwhere necessary to prevent excessiveexhaled air from adversely affectingfilters, cartridges, and canisters, ex-cept where filters of dust, fume, andmist respirators are specifically de-signed to resist moisture as prescribedin § 84.1145.

(c) Exhalation valves shall be:(1) Provided where necessary;(2) Protected against damage and ex-

ternal influence; and(3) Designed and constructed to pre-

vent inward leakage of contaminatedair.

§ 84.1138 Head harnesses; minimum re-quirements.

(a) All facepieces shall be equippedwith head harnesses designed and con-structed to provide adequate tensionduring use and an even distribution ofpressure over the entire area in contactwith the face.

(b) Facepiece head harnesses, exceptthose employed on single-use dust,fume, and mist respirators, shall be ad-justable and replaceable.

(c) Mouthpieces shall be equipped,where applicable, with adjustable andreplaceable harnesses, designed andconstructed to hold the mouthpiece inplace.

§ 84.1139 Air velocity and noise levels;hoods and helmets; minimum re-quirements.

Noise levels generated by the res-pirator will be measured inside thehood or helmet at maximum airflowobtainable and shall not exceed 80 dBA.

§ 84.1140 Dust, fume, and mist res-pirators; performance require-ments; general.

Dust, fume, and mist respirators andthe individual components of each suchdevice shall, as appropriate, meet therequirements for performance and pro-tection specified in the tests described

in §§ 84.1141 through 84.1152 and pre-scribed in Tables 12 and 13.

§ 84.1141 Isoamyl acetate tightnesstest; dust, fume, and mist res-pirators designed for respiratoryprotection against fumes of variousmetals having an air contaminationlevel not less than 0.05 milligramper cubic meter; minimum require-ments.

(a) The respirator will be modified insuch a manner that all of the air thatnormally would be inhaled through theinhalation port(s) is drawn through anefficient activated charcoal-filled can-ister, or cartridge(s), without inter-ference with the face-contacting por-tion of the facepiece.

(b) The modified respirator will beworn by persons for at least 2 minuteseach in a test chamber containing 100parts (by volume) of isoamyl-acetatevapor per million parts of air.

(c) The odor of isoamyl-acetate shallnot be detected by the wearers of themodified respirator while in the testatmosphere.

§ 84.1142 Isoamyl acetate tightnesstest; respirators designed for res-piratory protection against dusts,fumes, and mists having an air con-tamination level less than 0.05 milli-gram per cubic meter, or againstradionuclides; minimum require-ments.

(a) The applicant shall provide acharcoal-filled canister or cartridge ofa size and resistance similar to the fil-ter unit with connectors which can beattached to the facepiece in the samemanner as the filter unit.

(b)(1) The canister or cartridge willbe used in place of the filter unit, andpersons will each wear a modified half-mask facepiece for 5 minutes in a testchamber containing 100 parts (by vol-ume) of isoamyl-acetate vapor per mil-lion parts of air.

(2) The following work schedule willbe performed by each wearer in the testchamber:

(i) Two minutes walking, nodding,and shaking head in normal move-ments; and

(ii) Three minutes exercising andrunning in place.

(3) The facepiece shall be capable ofadjustment, according to the appli-cant’s instructions, to each wearer’s

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face, and the odor of isoamyl-acetateshall not be detectable by any wearerduring the test.

(c) Where the respirator is equippedwith a full facepiece, hood, helmet, ormouthpiece, the canister or cartridgewill be used in place of the filter unit,and persons will each wear the modi-fied respiratory-inlet covering for 5minutes in a test chamber containing1,000 parts (by volume) of isoamyl-ace-tate vapor per million parts of air, per-forming the work schedule specified inparagraph (b)(2) of this section.

§ 84.1143 Dust, fume, and mist air-puri-fying filter tests; performance re-quirements; general.

Dust, fume, and mist respirators willbe tested in accordance with the sched-ule set forth in Table 13 of this subpartto determine their effectiveness as pro-tection against the particulate hazardsspecified in Table 13.

§ 84.1144 Silica dust test for dust,fume, and mist respirators; single-use or reusable filters; minimum re-quirements.

(a) Three non-powered respiratorswith single-use filters will be tested forperiods of 90 minutes each at a contin-uous airflow rate of 32 liters perminute.

(b) The relative humidity in the testchamber will be 20–80 percent, and theroom temperature approximately 25° C.

(c) The test suspension in the cham-ber will not be less than 50 nor morethan 60 milligrams of flint (99+ percentfree silica) per cubic meter of air.

(d) The flint in suspension will beground to pass 99+ percent through a270-mesh sieve.

(e) The particle-size distribution ofthe test suspension will have a geo-metric mean of 0.4 to 0.6 micrometer,and the standard geometric deviationwill not exceed 2.

(f) The total amount of unretainedtest suspension in samples taken dur-ing testing shall not exceed 1.5 milli-grams for a non-powered air-purifyingrespirator.

(g) Three non-powered respiratorswith reusable filters will be tested andshall meet the requirements specifiedin paragraphs (a) through (f) of this

section; each filter shall be testedthree times: Once as received; onceafter cleaning; and once after reclean-ing. The applicant’s instructions shallbe followed for each cleaning.

§ 84.1145 Silica dust test; non-poweredsingle-use dust respirators; mini-mum requirements.

(a) Three respirators will be tested.(b) As described in § 84.1144, airflow

will be cycled through the respiratorby a breathing machine at the rate of24 respirations per minute with aminute volume of 40 liters; a breathingmachine cam with a work rate of 622kg.-m.2/minute shall be used.

(c) Air exhaled through the res-pirator will be 35° ±2° C. with 94 ±3 per-cent relative humidity. #

(d) Air inhaled through the respiratorwill be sampled and analyzed for res-pirator leakage.

(e) The total amount of unretainedtest suspension, after drying, in sam-ples taken during testing, shall not ex-ceed 1.8 milligrams for any single test.

§ 84.1146 Lead fume test for dust,fume, and mist respirators; mini-mum requirements.

(a) Three non-powered respiratorswill be tested for a period of 312 min-utes each at a continuous airflow rateof 32 liters per minute.

(b) The relative humidity in the testchamber will be 20–80 percent, and theroom temperature approximately 25° C.

(c) The test suspension in the testchamber will not be less than 15 normore than 20 milligrams of freshly gen-erated lead-oxide fume, calculated aslead (Pb), per cubic meter of air.

(d) The fume will be generated by im-pinging an oxygen-gas flame on moltenlead.

(e) Samples of the test suspensionwill be taken during each test periodfor analysis.

(f) The total amount of unretainedtest suspension in the samples takenduring testing, which is analyzed andcalculated as lead (Pb), shall not ex-ceed 1.5 milligrams of lead for a non-powered air-purifying respirator.

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Public Health Service, HHS § 84.1151

§ 84.1147 Silica mist test for dust,fume, and mist respirators; mini-mum requirements.

(a) Three non-powered respiratorswill be tested for a period of 312 min-utes each at a continuous airflow rateof 32 liters per minute.

(b) The room temperature in the testchamber will be approximately 25°C.

(c) The test suspension in the testchamber will not be less than 20 normore than 25 milligrams of silica mist,weighed as silica dust, per cubic meterof air.

(d) Mist will be produced by sprayingan aqueous suspension of flint (99+ per-cent free silica), and the flint shall beground to pass 99+ percent through a270-mesh sieve.

(e) Samples of the test suspensionwill be taken during each test periodfor analysis.

(f) The total amount of silica mistunretained in the samples taken duringtesting, weighed as silica dust, shallnot exceed 2.5 milligrams for a non-powered air-purifying respirator.

§ 84.1148 Tests for respirators de-signed for respiratory protectionagainst more than one type of dis-persoid; minimum requirements.

Respirators designed as respiratoryprotection against more than one par-ticulate hazard (dust, fume, or mist)shall comply with all the requirementsof this part, with respect to each of thespecific hazards involved.

§ 84.1149 Airflow resistance tests; alldust, fume, and mist respirators;minimum requirements.

(a) Resistance to airflow will bemeasured in the facepiece, mouthpiece,hood, or helmet of a dust, fume, ormist respirator mounted on a test fix-ture with air flowing at a continuousrate of 85 liters per minute, both beforeand after each test conducted in ac-cordance with §§ 84.1144 through 84.1147.

(b) The maximum allowable resist-ance requirements for dust, fume, andmist respirators are as follows:

MAXIMUM RESISTANCE[mm. water-column height]

Type of respirator Initial inha-lation

Final inhala-tion Exhalation

Pneumoconiosis- and fibrosis-producing dusts, or dusts and mists ............................. 12 15 15Dust, fume, and mist, with single-use filter ................................................................... 30 50 20Dust, fume, and mist, with reusable filter ...................................................................... 20 40 20Radon daughter ............................................................................................................. 18 1 25 15Asbestos dust and mist ................................................................................................. 18 25 15

1 Measured after silica dust test described in § 84.1144.

§ 84.1150 Exhalation valve leakagetest; minimum requirements.

(a) Dry exhalation valves and valveseats will be subjected to a suction of25 mm. water-column height while in anormal operating position.

(b) Leakage between the valve andvalve seat shall not exceed 30 milli-liters per minute.

§ 84.1151 DOP filter test; respiratorsdesigned as respiratory protectionagainst dusts, fumes, and mists hav-ing an air contamination level lessthan 0.05 milligram per cubic meterand against radionuclides; mini-mum requirements.

(a) All single air-purifying respiratorfilter units will be tested in an atmos-

phere concentration of 100 microgramsof DOP per liter of air at continuousflow rates of 32 and 85 liters per minutefor a period of 5 to 10 seconds.

(b) Where filters are to be used inpairs, the flow rates will be 16 and 42.5liters per minute, respectively, througheach filter.

(c) The filter will be mounted on aconnector in the same manner as usedon the respirator, and the total leakagefor the connector and filter shall notexceed 0.03 percent of the ambient DOPconcentration at either flow rate.

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§ 84.1152 Silica dust loading test; res-pirators designed as protectionagainst dusts, fumes, and mists hav-ing an air contamination level lessthan 0.05 milligram per cubic meterand against radionuclides; mini-mum requirements.

(a) Three non-powered respiratorswill be tested in accordance with theprovisions of § 84.1144, or equivalent,and shall meet the minimum require-ments of §§ 84.1144 and 84.1149.

(b) Three powered air-purifying res-pirators will be tested in accordancewith the provisions of § 84.1144 exceptthey will be tested for a period of 4hours each at a flowrate not less than115 liters per minute to tight-fittingfacepieces, and not less than 170 litersper minute to loose-fitting hoods andhelmets. The total amount ofunretained test suspension in samplestaken during testing shall not exceed14.4 milligrams for a powered air-puri-fying respirator with tight-fitting face-piece, and 21.3 milligrams for a poweredair-purifying respirator with loose-fit-ting hood or helmet. They shall meetthe minimum requirements of § 84.1149.

§ 84.1153 Dust, fume, mist, and smoketests; canister bench tests; gasmasks canisters containing filters;minimum requirements.

(a) Gas mask canisters containing fil-ters for protection against dusts,fumes, mists, and smokes in combina-tion with gases, vapors, or gases andvapors, will be tested as prescribed in§ 84.1140 except for the breathing resist-ance which will be in accordance with§ 84.122.

(b) Gas mask canisters designed forprotection against smokes will be test-ed in an atmospheric concentration of100 micrograms of dioctyl phthalateper liter of air at continuous flow ratesof 32 liters per minute and 85 liters perminute for a period of 5 to 10 seconds,and the DOP leakage through the can-ister shall not exceed 0.03 percent ofthe test concentration.

(c) Gas mask canisters containing fil-ters for protection against dusts,fumes, mists, and smokes in combina-tion with gases, vapors, or gases andvapors, will be tested as prescribed in§ 84.126.

§ 84.1154 Canister and cartridge re-quirements.

(a) Where two or more canisters orcartridges are used in parallel, their re-sistance to airflow shall be essentiallyequal.

(b) The color and markings of all can-isters and cartridges or labels shallconform with the requirements of theAmerican National Standards Insti-tute, American National Standard forIdentification of Air-Purifying Res-pirator Canisters and Cartridges, ANSIK13.1–1973. ANSI K13.1 is incorporatedby reference and has been approved bythe Director of the Federal Register inaccordance with 5 U.S.C. 552(a) and 1CFR part 51. Copies may be obtainedfrom American National Standards In-stitute, Inc., 1430 Broadway, New York,NY 10018. Copies may be inspected atthe NIOSH, Certification and QualityAssurance Branch, 1095 WillowdaleRoad, Morgantown, WV 26505–2888, orat the Office of the Federal Register,800 North Capitol Street, NW., suite700, Washington, DC.

§ 84.1155 Filters used with canistersand cartridges; location; replace-ment.

(a) Particulate matter filters used inconjunction with a canister or car-tridge shall be located on the inlet sideof the canister or cartridge.

(b) Filters shall be incorporated intoor firmly attached to the canister orcartridge and each filter assemblyshall, where applicable, be designed topermit its easy removal from and re-placement on the canister or cartridge.

§ 84.1156 Pesticide respirators; per-formance requirements; general.

Pesticide respirators and the individ-ual components of each such deviceshall, as appropriate, meet the follow-ing minimum requirements for per-formance and protection:

(a) Breathing resistance test. (1) Air-flow resistance will be measured in thefacepiece, mouthpiece, hood, or helmetof a pesticide respirator mounted on atest fixture with air flowing at a con-tinuous rate of 85 liters per minute,both before and after each test con-ducted in accordance with paragraphs(c) and (f) of this section.

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Public Health Service, HHS § 84.1156

(2) The maximum allowable resist-ance requirements for pesticide res-pirators are as follows:

MAXIMUM RESISTANCE[mm. water-column height]

Type of pesticide respiratorInhalation

ExhalationInitial Final 1

Front- or back-mounted gas mask ................................................................................ 70 85 20Chin-style gas mask ...................................................................................................... 65 80 20Powered air-purifying 2 .................................................................................................. 2 50 2 70 20Chemical Cartridge ........................................................................................................ 50 70 20

1 Measured at end of the service life specified in Table 14 of this subpart.2 Resistance of filter(s), cartridge(s), and breathing tube(s) only with blower not operating.

(b) Facepiece test. (1) The completepesticide respirator will be fitted tothe faces of persons having varying fa-cial shapes and sizes.

(2) Where the applicant specifies afacepiece size or sizes for his respiratortogether with the approximate meas-urements of faces they are designed tofit, the Institute will provide test sub-jects to suit such facial measurements.

(3) Any pesticide respirator partwhich must be removed to perform thefacepiece fit test shall be replaceablewithout special tools and without dis-turbing facepiece fit.

(4) The facepiece or mouthpiece fittest using positive or negative pressurerecommended by the applicant and de-scribed in his instructions will be usedduring each test.

(5)(i) Each wearer will enter a cham-ber containing 1,000 p.p.m. isoamyl-ace-tate vapor for a respirator equippedwith a full facepiece, mouthpiece,hood, or helmet and 100 p.p.m. isoamyl-acetate vapor for a respirator equippedwith a half-mask facepiece.

(ii) The facepiece, mouthpiece, hood,or helmet may be adjusted, if nec-essary, in the test chamber beforestarting the test.

(iii) Each wearer will remain in thechamber while performing the follow-ing activities:

(A) Two minutes, nodding and turn-ing head;

(B) Two minutes, calisthenic armmovements;

(C) Two minutes, running in place;and

(D) Two minutes, pumping with atire pump into a 28-liter (1 cubic foot)container.

(iv) Each wearer shall not detect theodor of isoamyl-acetate during thetest.

(c) Silica dust test. Three completelyassembled pesticide respirators will betested with a mechanical-testing appa-ratus as follows:

(1) Temperature in the test chamberwill be approximately 25° C.

(2) Continuous airflow through therespirator will be 32 liters per minutefor front-mounted, back-mounted, andchin-style gas mask pesticide res-pirators and chemical cartridge pes-ticide respirators, and not less than 115(4 cubic feet) liters per minute to tight-fitting facepieces and 170 liters (6 cubicfeet) per minute to loose-fitting hoodsand helmets of powered air-purifyingrespirators.

(3) The test aerosol will contain 50–60milligrams of 99+ percent free silicaper cubic meter of air.

(4) The particle size distribution ofthe test suspension will have a geo-metric mean diameter of 0.4 to 0.6 mi-crometer, with a standard geometricdeviation less than 2.

(5) Front-mounted, back-mounted,and chin-style gas mask pesticide res-pirators and chemical cartridge pes-ticide respirators will be tested for 90minutes and powered air-purifying res-pirators will be tested for 4 hours.

(d) Lead fume test. Three completelyassembled pesticide respirators will betested with a mechanical-testing appa-ratus as follows:

(1) Continuous airflow through therespirator will be 32 liters per minutefor front-mounted, back-mounted, and

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42 CFR Ch. I (10–1–97 Edition)§ 84.1157

chin-style gas mask pesticide res-pirators and chemical cartridge pes-ticide respirators and not less than 115liters (4 cubic feet) per minute, forpowered air-purifying respirators withtight-fitting facepieces, and not lessthan 170 liters (6 cubic feet) per minutefor powered air-purifying respiratorswith loose-fitting hoods and helmets.

(2) The test aerosol will contain 15–20milligrams of freshly generated lead-oxide fume, calculated as lead, percubic meter of air.

(3) The fume will be generated by im-pinging an oxygen-gas flame on moltenlead.

(4) Front-mounted, back-mounted,and chin-style gas mask pesticide res-pirators and chemical cartridge pes-ticide respirators will be tested for 90minutes and powered air-purifying pes-ticide respirators will be tested for 4hours.

(5) The total amount of unretainedtest suspension, which is analyzed andcalculated as lead, shall not exceed:

(i) 0.43 milligram for any 90-minutetest;

(ii) 4.8 milligrams for any 4-hour testmade at 115 liters (4 cubic feet) perminute; or

(iii) 6.2 milligrams for any 4-hour testmade at 170 liters (6 cubic feet) perminute.

(e) Dioctyl-phthalate test. (1) All can-isters submitted for use with front-mounted and back-mounted gas maskpesticide respirators will be tested inan atmospheric concentration of 100micrograms of dioctyl-phthalate perliter of air at continuous flow rates of32 and 85 liters per minute for a test pe-riod of 5 to 10 seconds.

(2) The DOP leakage through the can-ister shall not exceed 0.03 percent ofthe ambient DOP concentration.

(f) Bench tests for pesticide respirators.(1)(i) Bench tests will be made on anapparatus that allows the test atmos-phere at 50±5 percent relative humidityand at room temperature (25°±2.5° C.) toenter the canister or cartridge at pre-determined concentrations and rates offlow, and that has a means for deter-mining the test life of the canister orcartridge against carbon tetrachloride.

(ii) Canisters and cartridges will betested as they are used on each pes-

ticide respirator, either singly or inpairs.

(iii) Three canisters or cartridges orpairs of cartridges will be removedfrom containers and tested as receivedfrom the applicant.

(iv) Two canisters, cartridges, orpairs of cartridges will be equilibratedat room temperature by passing 25 per-cent relative humidity air throughthem at the following flow rates (ex-pressed as liters per minute (l.p.m.))for 6 hours:

Type of canister or cartridgeAirflowrate,l.p.m.

Air-purifying canister .............................................. 64Air-purifying cartridge ............................................ 25Powered air-purifying with tight-fitting facepiece ... 115Powered air-purifying with loose-fitting hood or

helmet ................................................................ 170

(v) Two canisters, cartridges, or pairsof cartridges will be equilibrated atroom temperature by passing 85 per-cent relative humidity air throughthem at the flow rates stated in para-graph (f)(1)(iv) of this section for 6hours.

(vi) The equilibrated canisters or car-tridges will be resealed, kept in an up-right position at room temperature,and tested within 18 hours.

(2) Canisters and cartridges tested inaccordance with the provisions of thissection shall meet the requirementsspecified in Table 14 of this subpart.

§ 84.1157 Chemical cartridge res-pirators with particulate filters;performance requirements; general.

Chemical cartridge respirators withparticulate filters and the individualcomponents of each such device shall,as appropriate, meet the followingminimum requirements for perform-ance and protection:

(a) Breathing resistance test. (1) Resist-ance to airflow will be measured in thefacepiece, mouthpiece, hood, or helmetof a chemical cartridge respiratormounted on a test fixture with airflowing at a continuous rate of 85 litersper minute, both before and after eachtest conducted in accordance withparagraphs (d) through (f) of this sec-tion.

(2) The maximum allowable resist-ance requirements for chemical car-tridge respirators are as follows:

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Public Health Service, HHS § 84.1157

MAXIMUM RESISTANCE[mm. water-column height]

Type of chemical cartridge respiratorInhalation

ExhalationInitial Final 1

For gases, vapors, or gases and vapors, and dusts, fumes, and mists ...................... 50 70 20For gases, vapors, or gases and vapors, and mists of paints, lacquers, and enamels 50 70 20

1 Measured at end of service life specified in Table 11 in subpart L of this part.

(b) Facepiece test. The facepiece testwill be conducted as specified in§ 84.205.

(c) Lacquer and enamel mist tests; gen-eral. (1) Three respirators with car-tridges containing or having attachedto them, filters for protection againstmists of paints, lacquers, and enamelsshall be tested in accordance with theprovisions of paragraph (f) of this sec-tion.

(2) In addition to the test require-ments set forth in paragraph (c)(1) ofthis section, three such respirators willbe tested against each aerosol in ac-cordance with the provisions of para-graphs (d) and (e) of this section.

(d) Lacquer mist test. (1) Temperaturein the test chamber will be approxi-mately 25° C.

(2) Continuous airflow through therespirator will be 32 liters per minutefor air-purifying respirators, and notless than 115 liters per minute to tightfitting facepieces and 170 liters perminute to loose-fitting hoods and hel-mets of powered air-purifying res-pirators.

(3) Airflow through the chamber willbe 20–25 air changes per minute.

(4) The atomizer employed will be aNo. 64–5 nozzle with setup 3, or equiva-lent, operating at 69 kN/m.2 (10 poundsper square inch gage).

(5) The test aerosol will be preparedby atomizing a mixture of one volumeof clear cellulose nitrate lacquer andone volume of lacquer thinner. The lac-quer described in Federal SpecificationTT–L–31, October 7, 1953, is an exampleof an acceptable lacquer. Copies of TT–L–31 may be inspected or obtained fromthe NIOSH, Certification and QualityAssurance Branch, 1095 WillowdaleRoad, Morgantown, WV 26505–2888.

(6) The concentration of cellulose ni-trate in the test aerosol will be 95–125milligrams per cubic meter.

(7) The test aerosol will be drawn toeach respirator for a total of 156 min-utes for air-purifying respirators and240 minutes for powered air-purifyingrespirators.

(8) The total amount of unretainedmist in the samples taken during test-ing, weighed as cellulose nitrate, shallnot exceed 5 milligrams for an air-puri-fying respirator, 28 milligrams for apowered air-purifying respirator withtight-fitting facepiece, and 41 milli-grams for a powered air-purifying res-pirator with loose-fitting hood or hel-met.

(e) Enamel mist test. (1) Temperaturein the test chamber will be approxi-mately 25° C.

(2) Continuous airflow through therespirator will be 32 liters per minutefor air-purifying respirators, and notless than 115 liters per minute to tight-fitting facepieces and 170 liters perminute to loose-fitting hoods and hel-mets of powered air-purifying res-pirators.

(3) Airflow through the chamber willbe 20–25 air changes per minute.

(4) The atomizer employed will be aNo. 64 nozzle with setup 1A, or equiva-lent, operating at 69 kN/m.2 (10 poundsper square inch gage).

(5) The test aerosol will be preparedby atomizing a mixture of 1 volume ofwhite enamel and 1 volume of turpen-tine. The enamel described in FederalSpecification TT-E–489b, May 12, 1953,with amendment-1 of 9 November 1955is an example of an acceptable enamel.Copies of TT-E–489b may be inspectedor obtained from the NIOSH, Certifi-cation and Quality Assurance Branch,1095 Willowdale Road, Morgantown, WV26505–2888.

(6) The concentration of pigment inthe test aerosol, weighed as ash, will be95–125 milligrams per cubic meter.

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42 CFR Ch. I (10–1–97 Edition)§ 84.1158

(7) The test aerosol will be drawn toeach respirator for a total of 156 min-utes for air-purifying respirators and240 minutes for power air-purifying res-pirators.

(8) The total amount of unretainedmist in the samples taken during test-ing, weighed as ash, shall not exceed 1.5milligrams for any air-purifying res-pirator, 8.3 milligrams for a poweredair-purifying respirator with tight-fit-ting facepiece, and 12.3 milligrams fora powered air-purifying respirator withloose-fitting hood or helmet.

(f) Bench tests; gas and vapor tests. (1)Bench tests will be made in accordancewith § 84.207 and tested cartridges shallmeet the minimum requirements setforth in Table 11 of subpart L of thispart. Cartridges will be equilibrated inaccordance with paragraph (f)(2) of thissection.

(2)(i) Two powered air-purifying car-tridges or pairs of cartridges will beequilibrated at room temperature bypassing 25 percent relative humidityair through them at the following flowrates (expressed in liters per minute(l.p.m.)) for 6 hours:

Type of cartridgeAirflowrate,l.p.m.

Powered air purifying with tight-fitting facepiece ... 115Powered air purifying with loose-fitting hood or

helmet ................................................................ 170

(ii) Two powered air-purifying car-tridges or pairs of cartridges will beequilibrated by passing 85 percent rel-ative humidity air through them at theflow rates stated in paragraph (f)(2)(i)of this section.

(iii) All cartridges will be resealed,kept in an upright position, at roomtemperatures, and tested within 18hours.

§ 84.1158 Dust, fume, and mist tests;respirators with filters; minimumrequirements; general.

(a) Three respirators with cartridgescontaining, or having attached tothem, filters for protection againstdusts, fumes, and mists, except themists of paints, lacquers, and enamels,will be tested in accordance with theprovisions of § 84.1157(f).

(b) In addition to the test require-ments set forth in paragraph (a) of thissection, three such respirators will betested, as appropriate, in accordancewith the provisions of §§ 84.1141 through84.1152; however, the maximum allow-able resistance of complete dust, fume,and mist, and gas, vapor, or gas andvapor chemical cartridge respiratorsshall not exceed the maximum allow-able limits set forth in § 84.1157(a)(2).

Tables to Subpart KK of Part 84TABLE 12.—FACEPIECE TEST REQUIREMENTS

[42 CFR Part 84, Subpart KK]

Respirator typesPressuretightness

test 1

Isoamyl acetate test

84.1141 84.1142

Dusts: Air Contamination Level not less than 0.05 mg/M3 or 2 mppcf ........................ XFumes: Air Contamination Level not less than 0.05 mg/M3 ......................................... X XMists: Air Contamination Level not less than 0.05 mg/M3 or 2 mppcf ......................... XDusts, Fumes, and Mists: Air Contamination Level less than 0.05 mg/M3 or 2 mppcf,

and radionuclides ....................................................................................................... X XRadon daughters ........................................................................................................... X XAsbestos-containing dusts and mists ............................................................................ X

1 Test is required only where applicable.

TABLE 13.—AIR-PURIFYING AND POWERED AIR-PURIFYING RESPIRATOR FILTER TESTS REQUIREDFOR APPROVAL

[42 CFR Part 84, Subpart KK]

Respirator typesSilica dust tests Lead fume

test 84.1146Silica mist

test 84.1147DOP test84.115184.1144 84.1145 84.1152

Dusts: Air Contamination Level not lessthan 0.05 mg/M3 or 2 mppcf .............. X

Fumes: Air Contamination Level notless than 0.05 mg/M3 ......................... X

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