PED Presentation Material

HSB Global Standards

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Pressure Equipment Directive Pressure Equipment Directive 97/23/EC (PED)97/23/EC (PED)

PED PED –– 97/23/EC97/23/EC

European

Pressure Equipment DirectivePressure Equipment Directive

http://ec.europa.eu/enterprise/sectors/pressure-and-gas/documents/ped/index_en.htm

Contents of DirectiveContents of Directive

Article 1 Scope and definitions

Article 2 Market surveillance

Article 3 Technical requirements

Article 4 Free movement

Article 5 Presumption of conformity

Article 6 & 7 Committee on Pressure Equipment

Article 8 Safeguard clause

Article 9 Classification of pressure equipment

Article 10 Conformity assessment


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Article 11 European approval for materials

Article 12 Notified bodies

Article 13 Recognized third-party organizations

Article 14 User inspectorates

Article 15 & 16 CE marking

Article 17 Member States

Article 18 Decisions entailing refusal or restriction

Article 19 Repeal

Article 20 Transposition and transitional provisions

Article 21 Addressees of the Directive


ANNEX I Essential Safety Requirements

ANNEX II Conformity Assessment Tables

ANNEX III Conformity Assessment Procedures

ANNEX IV Minimum Criteria to be met when ~

ANNEX V Criteria to be met when ~

ANNEX VI CE Marking

ANNEX VII Declaration of Conformity

GuidelinesGuidelines

• In order to ensure a coherent application of the Pressure Equipment Directive 97/23/EC (PED), Guidelines are developed and agreed by the Commission’s Working Group “Pressure” (WGP). This working group, created as a result of Article 17 of the PED, which requests the Member States to cooperate in order to assist the functioning of this Directive, is composed of representatives of Member States, European federations, the Notified Bodies Forum and CEN and chaired by a representative of the Commission services.

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Status of the guidelinesStatus of the guidelines

The PED Guidelines are not a legally binding interpretation of the Directive. The legally binding text remains that of the Directive.

However, the PED Guidelines represent a reference for ensuring consistent application of the Directive. They represent,

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yunless indicated differently in the respective guideline text, the unanimous opinion of the Member States.

Classification of the guidelinesClassification of the guidelines

1. Scope and Exclusions of the Directive (1/53)

2. Classification and Categories (2/40)

3. Assemblies (3/19)

4. Evaluation Assessment Procedures (4/15)

5. Interpretation of the Essential Safety Requirements on Design (5/8)

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p y q g ( )6. Interpretation of the Essential Safety Requirements on Manufacturing

(6/14)

7. Interpretation of the Essential Safety Requirements on Materials (7/26)

8. Interpretation of other Essential Safety Requirements (8/19)

9. Miscellaneous (9/24)

10. General-Horizontal Questions (10/6)

Guideline 1/8Guideline 1/8

Guideline related to: Article 1 paragraph 2.1.4

Question:

What is a pressure accessory?

Answer:

valves, pressure regulators, measurement chambers, pressure gauges,

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, p g , , p g g ,water gauge glasses, filters, expansion joints and manifolds.

The following examples are not pressure accessories:

- safety valve ( a safety accessory)

- cover, collar, gasket, flange, bolt (components of a pressure equipment)

- sight glass with its frames (components of a pressure equipment)

- Y-shape or similar fittings (piping components)


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REFERENCE GUIDEREFERENCE GUIDEfor Pressure Equipment Directivefor Pressure Equipment Directive

Member States Member States of the European Community (EC)of the European Community (EC)

AustriaBelgiumBulgariaCyprusCzech RepublicDenmarkEstonia

LithuaniaLuxembourgMaltaNetherlandsPolandPortugalRomaniaSlovakia

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FinlandFranceGermanyGreeceHungaryIrelandItalyLatvia

SloveniaSpainSwedenUnited Kingdom

Countries adopting DirectivesCountries adopting Directives

• European Free Trade Association (EFTA)– Norway, Iceland & Liechtenstein

• Associated CountriesAssociated Countries– Switzerland

• EC Candidate Countries– Croatia & Turkey

Requiring / Accepting PED


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DirectivesDirectives

• 73/23/EEC Low voltage equipment

• 89/686/EEC Personal protective equipment

• 93/42/EEC Medical devices

• 95/16/EC Lifts

• 96/98/EC Marine Equipment

• 97/23/EC Pressure Equipment

• 98/37/EC Machinery

• 2004/22/EC Measuring Instruments

• 2009/48/EC Toys Safety

• et cetera

CE MarkingCE Marking

• The CE Marking symbolises the conformity of the product with the applicable Community requirements imposed on the manufacturer

Th CE M ki ffi d t d t i d l ti b• The CE Marking affixed to products is a declaration by the person responsible that:– The product conforms to all applicable Community provisions

– The appropriate conformity assessment procedures have been completed

CE MarkingCE Marking

• CE Marking will be performed on Complete Equipment

• CE Marking cannot be performed on – Materials

I l i– Incomplete equipment

– Below Category 1 there is ‘Sound Engineering Practice (SEP)’

• The CE marking shall be affixed in a visible, easily legible and indelible fashion to each – item of pressure equipment, or

– assembly


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Implementation of the PEDImplementation of the PED

• Mandatory as of May 29, 2002

• Transition period began November 29, 1999

• Issued May 29, 1997

• Introduced May 1985

TerminologyTerminology

• CEN – European Committee for Standardization

• EC – European Community

• EN – European Standard

• PS(bar) – Maximum allowable pressure

• DN – Norminal size

• ESR – Essential Safety Requirements

• PMA – Particular Material Appraisal

• NoBo – Notified Body appointed by a Member State

• RTPO – Third Party Organization recognized by a Member State

Harmonized Standards (EN)Harmonized Standards (EN)

Prepared by CEN Committees with the specific aim of meeting ESRs

Unfired Pressure Vessels – EN 13445

Water Tube Boilers EN 12952 Water Tube Boilers – EN 12952

Shell Boilers (Firetube) – EN 12953

Qualification of Welding Procedures – EN 15614

Qualification Test of Welders – EN 287

NDE Personnel Qualification and Certification – EN 473

www.newapproach.org


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Harmonized Standards (EN)Harmonized Standards (EN)

• The use of Harmonized European Standards(EN) is not mandatory.

• Very little interest in the use of the product Harmonized Standards– Manufacturers content with

Known international standards – ASME

Those adopted to PD5500, DODAP, AD2000

• However, pressure equipment manufactured using harmonized standards is presumed to comply with the Essential Safety Requirements of the PED.

Who is Responsible?Who is Responsible?

• A manufacturer is the person who is responsible for design and manufacturing a product with a view to placing pressure equipment on the Community market on his own behalf.

• And the manufacturer is responsible for carrying out conformity assessment in accordance with the procedures laid down by the directive.

• No allowance for Manufacturer to share responsibility.

To be a “Manufacturer”To be a “Manufacturer”

• Responsible for design and manufacturing

• Responsible for carrying out Conformity Assessment

• The item must be “Whole”

• The item must be tested

If any of the above are not met, the fabricator is considered a “Subcontractor”


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SubcontractorsSubcontractors

• A fabricator who cannot fulfill the scope, design and pressure test requirements of a Manufacturer is defined as a Subcontractor.

• Subcontractors have responsibility for welding and NDE qualifications, and possibly material procurement.

• Material selection is the responsibility of the Manufacturer.

Manufacturer’s ResponsibilitiesManufacturer’s Responsibilities

• Design and manufacture the product in accordance with essential requirements laid down by the directive

• Selection of the Notified Body and Module(s) All subcontractors must use the selected Module and Notified

Body

Except for welding and NDE approval

• Pressure Testing

• CE-Marking

• Declaration of Conformity

Declaration of ConformityDeclaration of Conformity

• The manufacturer, or his authorized representativeestablished within the Community, must affix the CEmarking to each item of pressure equipment and drawup a written declaration of conformity.

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• The manufacturer, or his authorized representativeestablished within the Community, must keep a copy ofthe declaration of conformity for a period of tenyears after the last of the pressure equipment has beenmanufactured.


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Pressure Equipment Directive Pressure Equipment Directive OverviewOverview

Article 1Article 1 Scope and definitionsScope and definitions

All Pressure Equipment

PS > 0.5 bar

Pressure equipment meets all requirements of the Directive


“Pressure Equipment” means

• Vessels

• Piping

• Safety accessories- Safety valves, fluid level, pressure or temperature switches

• Pressure accessories- Valves, pressure gauges, water gauge glasses

- Operational function


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“Pressure Equipment” means

• Where applicable, pressure equipment includes elements attached to pressurized parts

flanges nozzles couplings supports lifting lugs etc- flanges, nozzles, couplings, supports, lifting lugs, etc.

• ‘Assemblies’- Several pieces of pressure equipment assembled by a

manufacturer to constitute an integrated and functional whole.


• Pressure – relative to atmospheric pressure, i.e. gauge pressure.

• Maximum allowable pressure PS– The max. pressure for which the equipment is designed, as

specified by the manufacturerspecified by the manufacturer.

• Maximum/Minimum allowable temperature TS– The max./min. temperature for which the equipment is designed,

as specified by the manufacturer.

• Volume (V)– The internal volume of a chamber, including the volume of

nozzles to the first connection for weld and excluding the volume of permanent internal parts.


• Nominal Size (DN)– A numerical designation of size which is common to all

components in piping system other than components indicated by outside diameters or by thread size.

• Fluid– Gases, liquids and vapours in pure phase as well as mixtures

thereof.

• Permanent Joints– Joints which cannot be disconnected except by destructive

methods.

• European approval for materials– A technical document defining the characteristics of materials.


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Article 3Article 3 Technical RequirementsTechnical Requirements

• The pressure equipment must satisfy the essential requirements set out in Annex I

• Type of Equipment- Vessel

- Steam Generator

- Piping

- Safety and pressure accessories

Article 3Article 3 Technical RequirementsTechnical Requirements

• Type of Fluid

- Gases, liquefied gases, gases dissolved under pressure, vapors and those liquids whose vapor pressure at max. allowable temperature is greater than 0.5 bar above normal atmospheric p g ppressure (1,013 mbar).

- Liquid having a vapor pressure at the max. allowable temperature of not more than 0.5 bar above normal atmospheric pressure (1,013 mbar).

Article 9Article 9 Classification of Pressure Classification of Pressure EquipmentEquipment

• Pressure equipment referred to in Article 3

(vessel, Steam Generator, Piping, Safety and Pressure Accessories)

shall be classified by category in accordance with Annex II, according to ascending level of hazard. C I II III IV Category I, II, III or IV

• For the purposes of such classification fluids shall be divided into two groups. Group 1

Group 2


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Article 9Article 9 Classification of Pressure Classification of Pressure EquipmentEquipment

• Group 1 – Dangerous Fluids (Directive 67/548/EEC)- Explosive,

- Extremely flammable,

- Highly flammable,

- Flammable (where the maximum allowable temperature is aboveFlammable (where the maximum allowable temperature is above flashpoint),

- Very toxic,

- Toxic,

- Oxidizing

• Group 2 – All other Fluids

Article 10Article 10 Conformity assessmentConformity assessment

• Before placing pressure equipment on the market, the manufacturer shall subject each item of equipment to one of the conformity assessment procedures described in Annex III.

• The conformity assessment procedures to be applied to an item of pressure equipment with a view to affixing the CE marking shall be determined by the category in which the equipment is classified.


• The conformity assessment procedures to be applied for the various categories are as follows:

– Category I

Module AModule A

– Category II

Module A1

Module D1

Module E1


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– Category III

Module B1 + D

Module B1 + F

Module B + E

Module B + C1

Module H

– Category IV

Module B + D

Module B + F

Module G

Module H1


• Pressure equipment shall be subjected to one of the conformity assessment procedures which may be chosen by the manufacturer among those laid down for the category in which it is classified.

• The manufacturer may also choose to apply one of the procedures which apply to a higher category, if available.

ANNEX IANNEX IEssential Safety RequirementsEssential Safety Requirements

1. General

2. Design

3. Manufacturing

4. Materials

5. Fired or otherwise heated pressure equipment with a risk of overheating as referred to in article 3 (1)

6. Piping as referred to in Article 3, Section 1.3

7. Specific quantitative requirements for certain pressure equipment


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ANNEX IIANNEX IIConformity Assessment TablesConformity Assessment Tables

Table 1 ~ 9

• The references in the tables to categories of modules are the following:

I - Module A

II - Modules A1, D1 & E1

III - Modules B1+D, B1+F, B+E, B+C1 or H

IV - Modules B+D, B+F, G or H1

ANNEX IIIANNEX IIIConformity Assessment ProceduresConformity Assessment Procedures

• Module A/A1

• Module B/B1

• Module C1

• Module D/D1

• Module E/E1

• Module F

• Module G

• Module H/H1

ANNEX VIANNEX VICE MARKINGCE MARKING

• The CE marking consists of the initials ‘CE’ taking the following form:


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ANNEX VIIANNEX VIIDeclaration of ConformityDeclaration of Conformity

• Name and address of the manufacturer

• Description of the pressure equipment or assembly

• Conformity assessment procedure followed

• Name and address of the notified body

A reference to the EC type examination certificate EC• A reference to the EC type-examination certificate, EC design-examination certificate or EC certificate of conformity

• The references of the harmonized standards applied

• Other technical standards and specifications used

• The references of the other Community Directives applied

Pressure Equipment Directive Pressure Equipment Directive ClassificationClassification

Hazard CategoriesHazard Categories

• Type of Pressure Equipment

• Type of Fluid:– Group 1 = Dangerous

– Group 2 = Non-dangerous

• Nature of Fluid:– Gas

– Liquid

• Pressure (in bar)

• Volume (in liters) / Nominal Size (DN)


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Selection of TablesSelection of Tables

Type Phase Group Table

VesselGas 1 Table 1

Gas 2 Table 2

Liquid 1 Table 3Liquid 1 Table 3

Liquid 2 Table 4

Steam Gen. Table 5

PipingGas 1 Table 6

Gas 2 Table 7

Liquid 1 Table 8

Liquid 2 Table 9

Conformity Assessment TablesConformity Assessment Tables

ANNEX II

• The demarcation lines in the following conformity assessment tables indicate the upper limit for each categorycategory.

Conformity Assessment Table 1Conformity Assessment Table 1


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Example :

– Type of Equipment : Pressure Vessel

– Content = Liquid Ethanol• Liquid is considered if it’s vapor pressure as at max allowable temperature is

not more than 0 5 bar above normal atmospheric pressure (1013 mbar)

Classification of Pressure EquipmentClassification of Pressure Equipment

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not more than 0.5 bar above normal atmospheric pressure (1013 mbar), pD<0.5bar @ T max)

– Design Pressure = 7500 psi (517 bar)

– Volume = 26 gallons (100 liters)

From the provided design data listed above, the equipment fall under Art 3 para 1.1(b) and then using Table 3 of Annex II


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Classification of Pressure equipment (hazard category) is based upon 4 items (Cont.)

• Example:Pressure equipment

With Hazard Category III

Classification of Pressure EquipmentClassification of Pressure Equipment

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Sound Engineering Practice (SEP)Sound Engineering Practice (SEP)

• Article 3 Paragraph 3 – Sound Engineering Practice

Pressure equipment and/or assemblies below or equal to the limits must ;

– Design and Manufacturing with a construction Code

– Accompany by adequate instructions for use

– Marking identification of the manufacturer with Design Data

– No CE Marking

Out of Scope of PED

Category ICategory I

Module A - Self declaration by the Manufacturer

CE Marking with no Notified Body involvement, self-certifying


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Category IICategory II

Module A1 - Manufacturer’s declaration with random monitoring by Notified Body

Module D1 - Production QA with technical documentation (ISO 9002)

M d l E1 P d t QA ith t h i l d t tiModule E1 - Product QA with technical documentation (ISO 9003 / Each Item examined and tests)

CE Marking with Notified Body involvement.- The Notified Body will either perform unexpected visits or audit a

quality system.

- The quality system is similar to ISO 9000

- Certification to ISO 9000 is not required.

Category IIICategory III

Module B1+D - Design examination plus production QA

Module B1+F - Design examination plus final examination

Module B+E - EC type examination plus product QA

Module B+C1 - EC type examination plus random final examination

Module H - Full QA (ISO 9001)

Category IIICategory III

CE Marking with Notified Body Involvement

• For this category, the Notified Body is required to approve the design or type for all Conformity A t P d ith ti f M d l HAssessment Procedures, with exception of Module H.

• For Module H, the manufacturer has an approved quality system that is equivalent to ISO 9001 and includes procedures for design control.


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Category IVCategory IV

Module B+D - EC type examination plus production QA

Module H1 - Full QA plus design examination & special surveillance

Module B+F - EC type examination plus final examination

Module G - Unit verification

(Most similar to traditional ASME AI)

CE Marking with Notified Body involvement.

For this category, the Notified Body is required to review or approve the design or type for all Conformity Assessment Procedures.

Pressure Equipment Directive Pressure Equipment Directive Conformity Assessment Conformity Assessment

ProcedureProcedureProcedureProcedure

Flow chart of Conformity Assessment Flow chart of Conformity Assessment ProcedureProcedure

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Conformity Assessment ModulesConformity Assessment Modules

The directive provides for a choice between 1.Direct Inspection based assessment Modules

– Module A1, C1, F, G, H1• F & G NoBo inspects each item and issue Certificate of Conformity

• A, C1, H1 NoBo monitoring only by means of “Unexpected Visit”

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2.Quality Assurance based assessment Modules– Modules D, D1, E, E1, H and H1

• Full QA similar to ISO 9001 (H/H1)

• Production QA similar to ISO 9002 (D/D1)

• Product QA similar to ISO 9003 (E/E1)

– When used with Hazard Category III or IV pressure equipment• Requires a Design Approval for H1

• HSBI’s policy is to review the first Module H design as a “desk top audit”


Module A :• Internal Production Control

• Self declaration by the Manufacturer

• Without involvement of NoBo

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Without involvement of NoBo

• CE Marking without NoBo involvement


Module A1: • Internal manufacturing check with monitoring of final

assessment.

• In addition to Module A, the following apply:

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g pp y– Final assessment must be performed by the manufacturer and

monitored by means of unexpected visits by a notified body chosen by the manufacturer.

• Should one or more of the items of pressure equipment not conform, the notified body must take appropriate measures.

• On the responsibility of the notified body, the manufacturer must affix the former's identification number on each item of pressure equipment


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Module B: • EC Type examination

• NoBo duties– review technical documentation

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– verify conformance to ESRs

– perform examination & tests

– issue EC-type exam certificates

• Valid for 10 years

• CE Marking with NoBo Number


Module B1: • EC Design Examination

• NoBo duties– review technical documentation

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– verify conformance to ESRs

– perform examinations to verify that manufacturer meets ESR

– issue EC design examination certificate

• Valid for 10 years



Module C1: • Conformity to Type

• NoBo duties– monitors the final assessment of the manufacturer by

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yunexpected visits and takes samples (like module A1).

• Must be combined with Module B



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Module D: • Production Quality Assurance

• NoBo duties– fully (re-)assesses the quality assurance system every three

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y ( ) q y y yyears and periodically audits it in between.

• Must be combined with Module B or Module B1



Module D1: • Production Quality Assurance (ISO 9002)


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Module E: • Product Quality Assurance


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– Must be combined with Module B



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Module E1: • Product Quality Assurance


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Module F: • Product Verification

• NoBo duties– verifies the approvals of personnel and the material certificates

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pp pand carries out the final assessment of each item of pressure equipment

• Must be combined with Module B or B1



Module G: • EC Unit Verification

• NoBo duties– examines the technical documentation, materials, procedures

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pand qualifications, checks the individual item of pressure equipment accordingly and carries out its final assessment.



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Module H: • Full Quality Assurance (ISO 9001)


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Module H1: • Full Quality Assurance (ISO 9001)

• NoBo duties– Design Examination and special surveillance.

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g p

– Final assessment is subject to increased surveillance in the form of unexpected visits by the notified body.


Notified Body InvolvementNotified Body Involvement

MODULE TITLE APPLICABLE

CATEGORY

CE MARK? NOTIFIED BODY

INVOLVEMENT?A Internal Production

Control

I Yes, without Notified

Body #.

No

A1 Internal Production

Control with Monitoring of Final Assessment

II Yes Yes

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B

must be combined with C1, D, E or F

EC type -Examination III, IV Yes Yes- ascertains and

attests that a representative

example of

production meets PED.

B1 EC design- Examination I, II (Table 4) and III Yes Yes – ascertains and

attests that design meets PED


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CATEGORY


INVOLVEMENT?

C1

must be combined with B

Monitoring of Final

Assessment

III Yes Yes

D Quality Assurance (QA) III, IV Yes Yes

must be combined with B or B1

Q y (Q )

for Production, Final Inspection and Testing

D1 QA for Production, Final

Inspection and Testing

II Yes Yes

E


QA for Final Inspection

and Testing

III Yes Yes

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CATEGORY


INVOLVEMENT?E1 QA for Final Inspection and

Testing

II Yes Yes

F


B1

Product Verification III, IV Yes Yes

or B1G Unit Verification IV Yes Yes – with

Certificate of Conformity

H Full QA III Yes Yes

H1 Full QA with Design

Examination and Monitoring of Final Assessment

IV Yes Yes

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PED PED –– Annex IAnnex IEssential Safety RequirementsEssential Safety Requirements


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1. General1. General

Pressure equipment must be designed, manufactured and checked, and if applicable equipped and installed, in such a way as to ensure its safety when put into service in accordance with the manufacturer’s instructions, or in reasonably foreseeable conditions.reasonably foreseeable conditions.

2. Design2. Design

• Design for adequate strength

• Provisions to ensure safe handling and operation

• Means of examination

• Means of draining and venting

C i th h i l tt k• Corrosion or other chemical attack

• Wear

• Assemblies

• Provisions for filling and discharge

• Protection against exceeding the allowable limits

• Safety accessories

• External fire

3. Manufacturing3. Manufacturing

• Manufacturing procedures– Preparation of the component parts

– Permanent joining

– Non-destructive tests

– Heat treatment

– Traceability

• Final assessment– Final inspection

– Proof test

– Inspection of safety devices

• Marking and labeling

• Operating instructions


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Permanent Joining

For pressure equipment, permanent joining of components which contribute to the pressure resistance of equipment and components which are directly attached to them must be carried out by suitably qualified personnel according to suitable operating procedures.

Welding/Brazing

Tube Expanding


Permanent Joining

For pressure equipment in categories II, III and IV, operating procedures and personnel must be approved by a competent third party which– A notified body,

– A third-party organization recognized by a Member State as provided for in Article 13.

To carry out these approvals the third party must perform examinations and tests as set out in the appropriate harmonized standards(EN15614/EN287) or equivalent examinations and tests or must have them performed.


Non-destructive tests

For pressure equipment,

• non-destructive tests of permanent joints must be carried out by suitable qualified personnel.carried out by suitable qualified personnel.

in categories III and IV,

• The personnel must be approved by a third-party organization recognized by a Member State.


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Proof test

Final assessment of pressure equipment must include a test for the pressure containment aspect. Which will normally take the form of a hydrostatic pressure test at a pressure at least equal, where appropriate, to the value laid down in 7.4.

For Category I series-produced pressure equipment, this test may be performed on a statistical basis.


7.4. Hydrostatic test pressure

For pressure vessels, the hydrostatic test pressure referred to in 3.2.2 Proof test must be no less than:– that corresponding to the maximum loading to which the g g

pressure equipment may be subject in service taking into account its maximum allowable pressure and its maximum allowable temperature, multiplied by the coefficient 1.25, or

– the maximum allowable pressure multiplied by the coefficient 1.43, whichever it the greater


Marking and labeling

In addition to the CE Marking for all pressure equipment:– Manufacturer’s name and address

– The year of manufacturey

– Identification / Serial Number of the pressure equipment

– Essential maximum/minimum allowable limits

– Notified Body Identification Number, where required per Module


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Marking and labeling

Additional Requirements, When Applicable– Volume(L) or Nominal Size(DN)

– Pressure Test(bar) and Date( )

– Safety Device Set Pressure(bar)

– Output(kW)

– Supply Voltage(volts)

– Intended Use

– Filling Ration(kg/L)

– Maximum Filling Mass(kg)

– Tare Mass(kg)

4. Materials4. Materials

Materials for pressurized parts must:

Have appropriate properties for all operating conditions which are reasonably foreseeable and for all test conditions, and in particular they should be sufficiently ductile and tough. Where appropriate, the characteristics of the materials must comply with the requirements of 7.5.


7.5. Material characteristics

Unless other values are required in accordance with other criteria that must be taken into account, a steel is considered as sufficiently ductile to satisfy 4.1 (a) if, in a tensile test carried out by a standard procedure, its elongation after rupture is no less than 14% and its bending rupture energy measured on an ISO V test-piece is no less than 27J, at a temperature not greater than 20 but not higher than the lowest scheduled operating temperature.


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The manufacturer must provide in his technical documentation elements relating to compliance with the materials specifications of the Directive in one of the following forms:– By using materials which comply with harmonized standardsBy using materials which comply with harmonized standards,

– By using materials covered by a European approval of pressure equipment materials in accordance with Article 11,

– By a particular material appraisal


Harmonized Standard Material

• A Only as listed in the harmonized Product Standard (e.g. EN 13445, EN 12952 & EN 12953)EN 13445, EN 12952 & EN 12953)

• No ASTM, ASME or other non-EN materials –Harmonized Product Standards will allow use of these materials through “Particular Material Appraisal”


EAM

• Shall be presumed to conform to the applicable essential requirements of Annex I.

• The notified body shall issue and withdraw the EAM

• Published in the Official Journal of the European Communities

http://ec.europa.eu/enterprise/sectors/pressure-and-gas/documents/ped/materials/published/index_en.htm


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PMA

• Performed by manufacturer for Categories I & II

• Approved by Notified Body for Categories III & IV

• Must meet ESRs for material

• Applicable for repeated use by that manufacturer only, within specified limits

• Keep list of PMAs issued and their ranges of approval

http://ec.europa.eu/enterprise/sectors/pressure-and-gas/files/pe-03-28-guiding-principles-for-the-content-of-pma_en.pdf


The equipment manufacturer must take appropriate measures to ensure that the material used conforms with the required specification.

In particular, documentation prepared by the material manufacturer affirming compliance with a specificationmanufacturer affirming compliance with a specification must be obtained for all materials.


For the main pressure-bearing parts of equipment in categories II, III and IV, this must take the form of a certificate of specific product control.

M i b i t Main pressure-bearing parts– Shells

– Ends

– Main body flanges

– Tube sheet of exchangers

– Tube bundles


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Where a material manufacturer has an appropriate quality-assurance system, certified by a competent body established within the Community and having undergone a specific assessment for materials, certificates issued by the manufacturer are presumed tocertificates issued by the manufacturer are presumed to certify conformity with the relevant requirements.


Competent body

– Can be any third party body established as a legal entity within the Community

– A notified body may perform this task only if it has a recognized competence in the field of quality assurance materials andcompetence in the field of quality assurance, materials and related process technology.

– The certificate of quality system shall make reference to the legal entity established in the Community and its address.

Pressure Equipment Directive Pressure Equipment Directive Roles & ResponsibilitiesRoles & Responsibilities


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Pressure Equipment ManufacturerPressure Equipment Manufacturer

• The PE Manufacturer is under an obligation to analyzethe hazards in order to identify those which apply to hisequipment on account of pressure: he must then designand construct it taking account of his analysis.

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• Designing and Manufacturing the product in accordancewith essential requirements laid down by the PED.

• Carrying out conformity assessment in accordance withthe procedures laid down by the PED.


• In choosing the most appropriate solutions, the PE Manufacturer must apply the principles set out below in the following order:– Eliminate or reduce hazards as far as is reasonably

practicable

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practicable,

– apply appropriate protection measures against hazards which cannot be eliminated,

– Where appropriate, inform users of residual hazards and indicate whether it is necessary to take appropriate special measures to reduce the risks at the time of installation and/or use.


• Must ensure the competent execution of the provisions set out at the design stage by applying the appropriate techniques and relevant procedures.

P f th Fi l t Fi l i ti P f t t

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• Perform the Final assessment – Final inspection, Proof test & Check of the safety devices for assemblies

• Affix the CE marking to each item of pressure equipment and draw up a written declaration of conformity.


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• Materials for pressurized parts

Providing in his technical documentation elementsrelating to compliance with the materials specificationsof the PED in one of the following forms:

by using materials which comply with harmonized

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– by using materials which comply with harmonizedstandards,

– by using materials covered by a European approval ofpressure equipment materials in accordance with Article11,

– by a particular material appraisal.


• Must take appropriate measures to ensure that thematerial used conforms with the required specification.

• In particular, documentation prepared by the materialmanufacturer affirming compliance with a specification mustbe obtained for all materials.

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be obtained for all materials.

• For the main pressure-bearing parts of equipment incategories II, III and IV, this must take the form of a certificateof specific product control.

• For Pressure Equipment, there is only one Manufacturer.

Notified BodyNotified Body

• Approve operating procedures and personnel forpressure equipment in categories II, III and IV at themanufacturer’s discretion.

• Perform a particular material appraisal in charge ofconformity assessment procedures for pressure

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conformity assessment procedures for pressureequipment in categories III and IV.

• The CE marking must be accompanied by the ID No. ofthe notified body for the pressure equipment applied tothe conformity assessment procedures among those laiddown for the categories II, III & IV.


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Recognized ThirdRecognized Third--Party OrganizationParty Organization

RTPO• Approve operating procedures and personnel for pressure

equipment in categories II, III and IV at the manufacturer’s discretion.

• Approve the personnel who perform non-destructive tests ofpermanent joints for pressure equipment in categories III and IV.

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Notified Body & RTPONotified Body & RTPO

• They may not become directly involved in the design, construction, marketing or maintenance of the pressure equipment or assemblies, nor represent the parties engaged in these activities.

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• Must carry out the assessments and verifications with the highest degree of professional integrity and technical competence.

• Must be free from all pressures and inducements, particularly financial, which might influence their judgment or the results of the inspection.


• Must have at its disposal the necessary personnel and possess the necessary facilities to enable it to perform properly the technical and administrative tasks connected with the inspection and surveillance operations, it must also have access to the equipment required to perform special

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verifications.

• Must take out liability insurance unless its liability is assumed by the State in accordance with national law, or the Member State itself is directly responsible for the inspections.


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For permanent joining

• A competent third party which may be a Notified Body or a RTPO must approve operating procedures and personnel for pressure equipment in categories II, III and IV at the

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pressure equipment in categories II, III and IV at the manufacturer’s discretion.

• To carry out these approvals the third party must perform examinations and tests as set out in the appropriate harmonized standards or equivalent examinations and tests or must have them performed.


Category NoBo /RTPO Approval of Permanent Joining Procedure & Personnel

RTPO Approval of NDE Personnel

Material with Certificate of Specific Product Control

PMA accepted by NoBo

0(SEP) No No No No

I No No No No

II Yes No Yes No

III Yes Yes Yes Yes

IV Yes Yes Yes Yes

NowNow!! You You are are an Expert for PED an Expert for PED ^0^^0^

Documents

PED Presentation Material