Government of Canada Specifications for COVID-19 Products (As at April 2, 2020)

Note: please check for regular updates using the following link: https://buyandsell.gc.ca/specifications-for-COVID-19-products#700

In support of the Government of Canada’s response to Coronavirus disease (COVID-19), we are providing the specifications for the various types of products below:

Disposable N95 masks

Specifications for filtering face pieces (eg. NIOSH N-95 Respirator)

Typical Alternative

Certification/Class Label NIOSH N-95 (42 CFR Part 84) CE FFP2 (EN149-2001) KN95 (GB2626-2006)

Labelling Information on

respirator

• Manufacturers Name

• TC-84A-####

• NIOSH

• Lot Number

• Filter designation (i.e. N95)

• Model Number

Additional information 1

• Manufacturer logo

• CE Labelling Number and

year of publication of standard

• Filter designation (i.e. FFP1, FFP2 or FFP3)

• Number and year of publication of standard

• Type and grade of filter elements (i.e KN95)

Additional • Must be a tight fitting respirator and able to perform a facefit test

• Must have two straps, preferably head straps

Documents

vendors/manufacturers

should be ready to

provide upon request

• Certificate of Compliance issued by the

manufacturer stating that the product meets all quality verifications

• Valid EN-149-2001

certificate identifying the product that has be certified

• Certificate of Compliance

issued by the manufacturer

stating that the product meets

all quality verifications

• Valid GB2626-2006

certificate identifying the

product that has be certified

• Certificate of Compliance

issued by the manufacturer

stating that the product meets

all quality verifications

• Test data for the KN95 respirator

1 https://www.cdc.gov/niosh/npptl/topics/respirators/disp_part/respsource1quest2.html

Disposable surgical masks

Specifications for filtering face pieces (eg. Surgical, Procedural, Medical Mask)

Test

Typical Canada/US

ASTM F2100

EN 14683

Level 1 Level 2 Level 3 Type IIR

Bacterial Filtration Efficiency, % ≥95 ≥98 ≥98 ≥98

Differential Pressure mm H2O/cm2

(Pa/cm2)

<4.0

<39.2

<5.0

<49.0

<5.0

<49.0 <5.0

Submicron particulate filtration efficiency

at 0.1 micron, % ≥95 ≥98 ≥98 Not Required

Splash Resistance/Synthetic Blood

Resistance, mmHg 80 120 160

120

(16.0kPa)

Flame Spread Class 1 Class 1 Class 1 N/A

Nitrile gloves / Vinyl gloves

Vendors/manufacturers of gloves (ex. nitrile gloves, vinyl gloves) should submit via the COVID-19 form.

Specifications on gloves

Medical gloves are classified as Class II devices, and must be licensed as such. This is the case

whether the gloves are made of latex, vinyl, synthetic polymer or nitrile, or are sterile or non-

sterile. For example, disposable, non-sterile, polyethylene gloves in first aid kits are medical

gloves. They protect both the patient and the wearer.

The Canadian standard is for glove to be compliant to ISO 11193-1, or to ASTM D3578

depending on their material.

However, if a glove is EN 455 compliant, then it also meets the required standard.

Applicable standards Canada USA Europe Standard ISO 11193-1:2008 ASTM D 3578:2005 EN 455-1:2000

Single use medical Standard specification Freedom from holes examination gloves – for rubber examination EN 455-2:2009 Physical

Part 1: Specification for gloves made from rubber latex or rubber solution

gloves Properties EN 455-3:2006 Biological evaluation EN 455-4:2009 Shelf life determination

Although Canada requires gloves to meet requirements as laid out in ISO 11193-1:2008 standard, it

can be noted that CGSB (Canadian General Standards Board) tests for powder residual (ASTM D6124)

and protein (ASTM D6499) as well.

Each standard has its own specifications, but they cover:

Freedom from holes

Dimensions Physical properties

Protein leaching

Powder residue

Powder amount

Shelf life

ISO X X X ASTM X X X X X X

EN X X X X X X

Freedom from holes:

Standard Acceptable Quality Level Volume of water (mL) Observations ISO 11193-1 2.5% 1000 +/- 50 Immediately & after about 2 min ASTM D3578 2.5% Min 1000 Immediately & after about 2 min EN 455-1 1.5% 1000 +/- 50 Immediately & after about 2 min

Acceptable Quality Level (% of glove failures per lot before rejecting the lot) of ISO and ASTM is

2.5%, while EN requires an AQL of 1.5%. They all use 1L of water, with observations

immediately and after about 2 min.

Physical properties:

Force at break (N) Tensile strength (Mpa) Standard Unaged Aged Unaged Aged Cutter width ISO 11193-1 7.0 6.0 14.6 12.5 4.0 mm ASTM D3578 18 14 N/A N 455-2 9.0 6.0 25 16.7 3.0 mm

For reference, since Government of Canada refers back to ISO 11193-1, and ASTM D3578-05, here are their respective specifications:

ISO 11193-1 and ASTM 3578-5 are further broken down in the following standards for testing:

Nitrile Vinyl Latex ASTM D6319 – Standard specification for Nitrile medical examination gloves X ASTM D5250 – Standard specification for poly(vinyl chloride) medical exam gloves

X

ASTM D412 – Standard test methods for vulcanized rubber and thermoplastic elastomers tension

X

ASTM D3767 – Standard practice for rubber measurement of dimensions X ASTM D3578 – Standard specification for rubber examination gloves X ASTM D6499-03 – Standard Test Method for the Immunological Measurement of Antigenic Protein in Natural Rubber and its Products.

X

ASTM D412 – Standard test methods for vulcanized rubber and thermoplastic elastomers tension

X X X

ASTM D5151 – Standard test method for detection of holes in medical gloves

X X X

ASTM D6124 – Standard test method for residual powder on medical gloves X X X ASTM D6978 – Standard practice for assessment of resistance of medical gloves to permeation by chemotherapy drugs

X

ASTM F1671 – Standard test method for resistance of materials used in protective clothing to penetration by blood-borne pathogens using Phi-X174 Bacteriophage penetration as a test system

X X X

ASTM F739 – Standard test method for permeation of liquids and gases through protective clothing materials under conditions of continuous contact

X X

ISO 21171:2006 Medical gloves — Determination of removable surface powder

X X X

Acceptance Criteria

Medical gloves must comply with the following criteria:

1. Material

Natural Rubber Latex - ISO 11193-1:2008, type 1 or ASTM D 3578:2005 or EN 455-1 and EN 445-2

Nitrile Rubber Latex - ISO 11193-1:2008, type 2 or ASTM D 6319:2019 or EN 455-1 and EN 445-

2

Poly(vinyl chloride) - ASTM D5250-06 (2011) or ISO 11193-2:2006

2. Quality management systems — Requirements for regulatory purposes:

Vendors/manufacturers must be ISO 13485:2016 certified.

3. Acceptable documents:

Compliance certifications

Product test reports. The laboratories must be accredited to ISO/IEC 17025 (General

requirements for the competence of testing and calibration laboratories) by the Standards

Council of Canada (SCC) or other accreditation organizations with which the SCC has signed a

Mutual Recognition Agreement. The test reports must be less than 12 months old.

Gowns and coveralls Specifications for surgical and medical gowns, and coveralls

Vendors/manufacturers should be ready, upon request, to specify:

the level or class that the gowns or coverall are classified to

the methods of evaluation used to classify the products

the level of risk (Low Risk and High Risk) as identified below

North American Standards European equivalencies

CSA Z314 (Canada) and ANSI PB70 (USA) EN 13795, for Gowns EN 14126, for Coveralls

Classification Standard / Testing Classification Standard / Testing Classification Standard / Testing

Low

Risk

Level 1

Minimal water

resistance (some

resistance to water

spray)

AATCC 42 - Water

penetration ≤ 4.5 g

AATCC 127 -

Hydrostatic pressure

N/A

Standard

Performance

EN 20811 – Hydrostatic

pressure

• Less critical areas ≥

10cm

• Critical areas ≥ 20cm

Class 1

ISO 16603 (Blood) &

16604 (Viral): No

penetration at 0 kPa

Class 2

ISO 16603 (Blood) &

16604 (Viral):

No penetration at 1.75

kPa

Level 2

Low water resistance

(resistant to water

spray and some

resistance to water

penetration under

constant contact with

increasing pressure)

AATCC 42 - Water

penetration ≤ 1.0 g

AATCC 127 -

Hydrostatic pressure ≥

20cm water column

Class 3

ISO 16603 (Blood) &

16604 (Viral):

No penetration at 3.5

kPa

Class 4

ISO 16603 (Blood) &

16604 (Viral):

No penetration at 7 kPa

High

Risk

Level 3

Moderate water

resistance (resistant to

water spray and some

resistance to water

penetration under

constant contact with

increasing pressure)

AATCC 42 - Water

penetration ≤ 1.0 g

AATCC 127 -

Hydrostatic pressure ≥

50cm water column

High

Performance

EN 20811 – Hydrostatic

pressure

• Less critical areas ≥

10cm

• Critical areas ≥ 20cm

Class 5

ISO 16603 (Blood) &

16604 (Viral): No

penetration at 14 kPa

Level 4

Blood and viral

penetration resistance

(2 psi)

ASTM F1670 (Blood) &

F1671 (Viral):

No penetration at 2 psi

(13.8 kPa)

Class 6

ISO 16603 (Blood) &

16604 (Viral): No

penetration at 20 kPa

Eye protection

Eye protection includes safety glasses, safety goggles and face shields, and must meet the following specifications:

Goggles Face Shields

Hazard Corrected Impact and splash Impact and splash

Safety Features

Shield entire eyes

Impact-resistant lenses

Ability to wear over eye glasses

Shield entire face

Easily removable in case of accidents

Medium impact resistant

Size One size fits all: adjustable strap One size fits all: 50cm - 64cm.

Material Polycarbonate (clear) Polycarbonate (clear)

Reusable Yes Yes

Head strap Yes Yes

Water resistant Yes Yes

Medical Device Classification

Yes

Level :1

Yes

Level :1

Hand sanitizer

Alcohol-based hand sanitizer could kill bacteria and viruses by denaturing the protective outer proteins of microbes and dissolving their membranes. Proper concentration of these alcohols are effective against killing germs and protecting the skin of those who apply it.

Vendors/manufacturers are required to provide bottles of hand sanitizer. The recommended quantity ranges from 100mL to 2L per bottle. These bottles should have a dispensing system such as:

Pump

Squeeze bottle

Nozzle spray

Pouring mechanism

The hand sanitizers must contain one of these approved active medicinal ingredients:

Common name Source material Quantity Product form

Alcohol Ethanol 60 - 80% Liquid

Anhydrous alcohol Ethanol 60 - 80% Gel, solution, spray foam, liquid

Ethanol Ethanol 60 - 80% Gel, solution, spray, foam, liquid, aerosol

Ethyl alcohol Ethanol 60 - 80% Liquid

Grain alcohol Ethanol 60 - 80% Gel, solution, spray, foam, liquid, tincture

Isopropanol Isopropanol 60 - 75% Liquid, pad

Isopropryl alcohol Isopropanol 60 - 75% Gel, solution, liquid, tincture, swab

Ventilators

Vendors/manufacturers for various types of ventilators (ICU-level ventilators, transport ventilators, etc.) should submit via the COVID-19 form.

Please note that the following specifications are related to ICU-level ventilators only:

Mandatory Technical Specifications for Ventilators:

1. The ventilator must be suitable to use with Pediatric and Adult aged populations, and optional with Neonatal populations.

2. The ventilator must provide mandatory and spontaneous breath types.

3. The ventilator must provide the following standard ventilation modes:

a. Controlled ventilation - Pressure Control (PC) and Volume Control (VC)

b. Supported ventilation - Pressure Support (PS) / CPAP)

c. Combined ventilation - SIMV(VC) + PS and SIMV(PC) + PS and Airway Pressure Release Ventilation (APRV) / biphasic or equivalent

4. The ventilator must have back-up ventilation (volume and pressure) triggered by the low minute volume alarm in ventilation modes with spontaneous breathing.

5. The ventilator must have the following parameters and features:

a. Inspiratory Tidal Volume: 5 - 2000 mis

b. Inspiratory Pressure Level: 0 - 80cmH2O

c. Frequency (f): 1 -150 breaths per minute

d. Pressure Support above PEEP: 0 - 60 cmH20

e. Positive End Expiratory Pressure (PEEP): 0 - 35cmH20

f. Oxygen Concentration: 21 - 100%

g. Peak Inspiratory Flow Range: 0 - 150 litres per minute or greater

h. Inspiratory Time (Tinsp): 0.1 - 5 seconds

i. Flow pattern: square and deceleration ramp

j. Inspiratory Rise Time (seconds): 0 - 0.4s

k. Flow and pressure trigger sensitivity

l. Suction support (pre oxygenation time: 2 minutes)

m. Alarm silence (2 minutes) and reset

6. The ventilator must have the following alarm settings and features:

a. Airway Pressure (upper/lower limits)

b. Expired Minute Volume (upper/lower limit)

c. Respiratory Frequency

d. Oxygen Concentration

e. Apnea

f. Safety Valve Open

g. Gas Supply

h. Battery

i. Ventilator Inoperative

j. Event and Alarm Log

k. Alarm Volume: 45dBA - 85dBA

7. The ventilator must be able to display coloured parameters and have touch screen capabilities with the following monitored data:

a. Ventilation mode and breath type

b. Delivered FI02

c. Airway Pressures (including peak, mean, plateau and end expiratory pressure)

d. Respiratory Rate

e. Tidal Volume

f. Minute Volume

g. I:E Ratio

h. Graphic display of pressure, flow and volume waveforms and loops

8. The ventilator must provide 99.9% effective filtration via inlet filter to protect all internal parts from viruses, bacteria, dust and other particulate contaminants.

9. The ventilator must provide either internally or as an attachment a heated N100 expiratory valve assembly for infection control purposes.

10. The ventilator must come equipped with a humidifier, temperature probe and supporting cable(s) as well as DISS Air and O2 gas hoses and fittings, moveable stand with wheels, patient tubing stand and arm and configure each ventilator to Public Health Agency of Canada (PHAC) requirements with a supply of disposable equipment including 16 humidifiers ready to be mounted and integrated onto the ventilator with appropriate patient circuits able to accept sterile water and temperature probes.

11. The ventilator must have an internal built-in air compressor or allow for the additional feature that enables the ventilator to operate without a separate Air/O2 gas source.

12. The ventilator must have a standard electrical power supply of 100 - 120 V AC ± 10%, 50 - 60 Hz and power cords must be CSA approved.

13. The ventilator must have all associated documentation to support the operation of each unit (Operator manuals in both official languages, quick reference sheets, etc.) as well as the list of all consumables needed to operate the ventilator in the following patient modes Adult/Paediatric/Neonatal. (Patient circuits, filters, SST user test tubing and lungs, etc.)

14. The ventilator must have the following gas supply features:

a. Inlet gas pressure: 29 - 94 PSI / 200 - 650 kPa

b. Pneumatic oxygen and medical air DISS connections

c. Oxygen and medical air high pressure hoses CSA approved

d. Flow is automatically compensated with the loss of one of the gas pressures

15. The ventilator must come with two (2) complete sets of all appropriate test equipment and calibration tools.

(Ventilator tester, calibration software, interface cables, test lungs, test jigs, measuring devices, fittings, plugs, etc.)

16. Upon award of contract for the procurement of approved ventilator units, the manufacturer must provide manufacturer level training for two (2) PHAC staff at manufacturer’s facility with required service manuals, hotel accommodations and course tuition costs.

17. The ventilator must be a registered medical device with Health Canada.

18. Units must come with two (2) year additional warranties that include annual O2 cell replacements and batteries.

19. Each unit must come with an air-worthy, hard-shelled, plastic or equivalent protective shipping container for deployments.

20. Each ventilator must be accompanied by all consumables and components required to operate with 1 neonatal patient; 1 paediatric patient and 3 adults patients (total of 5 consumable packages per ventilator).

Thermometers

For use in a hospital setting, oral and rectal thermometers are preferred as they provide the most accuracy. Digital thermometers require probe covers to be included for effective disinfection and avoiding cross-contamination. Thermometer probe covers are required for single-patient use digital thermometers. Non-digital thermometers are single-use and disposable.

The thermometers should contain the below specifications:

Characteristic Specification

Reusable Yes

Range 35 – 43°C

Accuracy ± 0.1°C

Reading time 4 – 14 seconds

Portable Yes

Battery or Plug into 110Vac Yes

Auto on/off Yes

Disposable Sterile Covers Yes

Easy removable sterile covers Yes

Oral Yes

Memory Recall of last reading Yes

Latex Free Yes

Waterproof Yes

Cord Length >3’

The thermometers should fall under one of these categories:

1. Reusable digital thermometer for oral or rectal use

These thermometers are usually equipped with a cord and are designed to increase productivity and patient safety. The removable/interchangeable oral and rectal probes and probe wells are intended to help you reduce the risk of cross contamination. These are the most recommended for hospital use.

2. Digital thermometers for ear use

These thermometers measure the temperature inside of the ear by reading the infrared heat. Ear thermometers require probe covers to reduce the risk of cross contamination between individuals. Infrared thermometers are usually used at ports of entry and in quarantine zones.

3. Digital thermometers for oral or rectal use

These thermometers are mostly used in testing sites and quarantine zones to remove any chance of cross-contamination. Probe covers to be purchased for digital thermometers. Oral and rectal thermometers are differentiated by blue for oral and red for rectal.