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Pressure Equipment Directive 97/23/EC

An Introduction

Vishnumurthi Ragavendhra Rao


06 August 2014

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New Approach and Global Approach

1. New Approach and Global Approach


2. EU Product Directive/ CE Marking
3. Pressure Equipment Directive 97/23/EC (PED)
4. Scope and Definition
5. Classification
6. Materials
7. Welding
8. NDE
9. Final Assessment
10. Annex I – ESRs
11. Conformity Assessment Modules
12. Documentation – General Guideline
13. Questions and Answers

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New Approach and Global Approach

 Basis: Article 95 paragraph 3 of the EC Treaty


(http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:12002E095:EN:HTML)

– The Commission, in its proposals envisaged in paragraph 1 concerning health, safety,


environmental protection and consumer protection, will take as a base a high level of
protection, taking account in particular of any new development based on scientific
facts. Within their respective powers, the European Parliament and the Council will also
seek to achieve this objective.
 Three important reference documents:
1. Council Resolution of 07.05.1985, where a 'New Approach to technical
harmonization and standards' is seen as an essential condition for
improving the competitiveness of European industry.
2. Council Resolution of 21.12.1989 on a Global Approach to certification and
testing, which states the guiding principles for Community policy on
conformity assessment.
3. The Global Approach was completed by Council Decision 93/465/EEC. This
Decision lay down general guidelines and detailed procedures for conformity
assessment that are to be used in New Approach directives.

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New Approach and Global Approach

Guidance
 The Web:
http://ec.europa.eu/enterprise/policies/european-standards/harmonised-standards/new-approach_en.htm

 The Blueguide:
http://ec.europa.eu/enterprise/policies/single-market-goods/files/blue-guide/guidepublic_en.pdf

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Implementation

EEA Member States Enforcing EU Product Directives:

European Union Members (EU: 28MS)


Germany, France, UK, Italy, Netherlands, Spain, Denmark, Belgium, Ireland,
Portugal, Greece, Luxembourg, Austria, Finland, Sweden, Czech Republic, Cyprus,
Estonia, Hungary, Latvia, Lithuania, Malta, Poland, Slovakia, Slovenia, Bulgaria,
Romania and Croatia

European Free Trade Association (EFTA: 4MS)


Norway, Iceland, Liechtenstein, Switzerland

European Economic Area (EEA)


EU+EFTA (-Switzerland)
However Switzerland is linked to the European Union by the Swiss–EU bilateral agreements.

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EU Product Directive

1. New Approach and Global Approach


2. EU Product Directive/ CE Marking
3. Pressure Equipment Directive 97/23/EC (PED)
4. Scope and Definition
5. Classification
6. Materials
7. Welding
8. NDE
9. Final Assessment
10. Annex I – ESRs
11. Conformity Assessment Modules
12. Documentation – General Guideline
13. Questions and Answers

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EU Product Directive

EU Product Directive

 A Law passed by the EU that must be implemented by all EEA member states.
The law (Directive) is binding upon the member state as to the objective to be
achieved, with limited leeway as to how to achieve it.
 Intended to remove technical barriers to trade by establishing a commonly
accepted level of safety.
 Applies to
Example: Directive 97/23/EC covering Pressurised Equipment

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EU Product Directive

Machinery Low Voltage Pressure ATEX Directive EMC Directive


Directive Equipment
Directive
Directive

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‘New Method’ Directives

List of directives based on New Approach and Global Approach


 Directives based on the principles of the New Approach which provide for CE
marking
 Directives based on the principles of the New Approach or the Global Approach,
but which do not provide for CE marking
 Directives based on the principles of the New Approach and the Global Approach
 Proposals for directives based on the principles of the New Approach or the Global
Approach)

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Definitions

 Placing on the market


“The making available, against payment or free of charge, of a product covered
by the Directive, and intended for a user, in the Community market for the
purpose of distribution and/or use on the Community territory ”
 Putting into service
“The first use on the Community territory, by its end user, of a product referred to
in the Directive ”

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Definitions (contd.)

 Manufacturer
“Any natural or legal person who designs or
manufactures a product or who has such a
product designed or manufactured, and markets
that product under his name or trademark ”

 Authorised representative
“Any natural or legal person established within the
Community, appointed by the manufacturer by a
written mandate, to act on his behalf in respect of
certain obligations of the manufacturer “
 Importer
“Any natural or legal person established within the
Community, who places a product from a third
country on the Community market “

Ref.: http://ec.europa.eu/enterprise/policies/single-market-goods/free-movement-non-harmonised-sectors/

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Definitions (contd.)

 European Commission: Executive arm of the of the European Union, responsible


for development and enforcement of EU Directives
 Notified Body: a third party body, appointed by the national authority of an EEA
member state, for performing conformity assessment for specific EU Product
Directives
(http://ec.europa.eu/enterprise/newapproach/nando/index.cfm?fuseaction=notifiedbody.main)

 Recognized Third Party Organization: a third party appointed by the national


authority of an EEA member state, specifically for approval of welding and NDE
procedure and personnel approval.

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Product Directive/ National Legislation

Placing on the market and putting into service (free movement)


Making available for the first time and first use by the end user within the
Community

European Legislation (addressing safety)


Specific directives 97/23/EC (PED) & 2009/105/EC (SPVD)
General product safety directive 2001/95/EC (GPSD)

Operation of the equipment (mainly national competence)


E.g. labour safety, installation, periodic inspections, repairs

EU legislation sets minimum requirements for labour safety


National legislation must not conflict with PED
http://www.dsb.no/no/Ansvarsomrader/Farlige-stoffer/Brannfarlig-reaksjonsfarlig-og-trykksatt-stoff/Veiledninger/

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Principles

 Products placed on the Community market shall comply with all applicable
legislation (product directives).
 The manufacturer, having detailed knowledge of the design and production
process, is best placed to carry out the complete conformity assessment
procedure. Conformity assessment should therefore remain the obligation of the
manufacturer alone.
 Standards and presumption of conformity
– EC directives define the "essential requirements", e.g., protection of health and
safety, that goods must meet when they are placed on the market.
– The European standards bodies have the task of drawing up the corresponding
technical specifications meeting the essential requirements of the directives,
compliance with which will provide a presumption of conformity with the
essential requirements. Such specifications are referred to as "harmonised
standards". See list on http://ec.europa.eu/enterprise/policies/european-
standards/documents/harmonised-standards-legislation/list-references/index_en.htm

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Principles (contd.)

‘Harmonized’ Product Standard: A technical standard, reviewed and approved


by the European Commission, which, when used in full, satisfied all Essential Safety
Requirements of relevant EU Product Directives.

‘Harmonized’ Support Standard: A technical standard, reviewed and approved


by the European Commission, which satisfies specific requirements of EU Product
Directives, such as issues related to welding, material specifications, NDE Operator
qualifications. Example: EN ISO 15614 series (welding procedure qualification)

Each harmonized standard will contain an annex stating which essential safety requirements it satisfies. The
advantage of using these standards is that no additional justification is required that essential
safety requirements have been met and providing the standards have been correctly applied the design of the
equipment can not be challenged.

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Annex ZA

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Principles (contd.)

 Liability for defective products (producer liability)


– The advantages of the Single market in facilitating the availability in all member
States of a wide range of products from all corners of the Union must be made
available within a framework which assures citizens of the safety of those
products and the possibility to claim compensation in case of damages caused
by defective products. Since 1985, the EU Internal Market counts on a
framework of product liability set up to satisfy both concerns.
– Directive 1985/374 and Directive 1999/34 apply to any product marketed in the
European Economic area and is of direct concern for both citizens and
producers in that area. By striking a fair balance of risk among citizens and
producers, this legislation aims to converge consumers’ interests with Single
Market policies (namely free exchange of goods and elimination of competition
distortions).

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Non-compliant Product

User
Authority

Market

Manufacturer

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CE Marking

The CE mark, denoting: “Communauté Européenne” confirms


that a product complies with all relevant EU Product Directives.

CE Marking declares the completion of conformity assessment


and that the equipment or assembly complies with the
provisions of the Directive and meets the Essential Safety
Requirements.

To be accompanied with the identification number for the


Notified Body responsible for surveillance (assessment of the 0575
production), e.g. for DNV 0575

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Declaration of Conformity

Content requirements given in the


individual directive

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Pressure Equipment Directive 97/23/EC

1. New Approach and Global Approach


2. EU Product Directive/ CE Marking
3. Pressure Equipment Directive 97/23/EC (PED)
4. Scope and Definition
5. Classification
6. Materials
7. Welding
8. NDE
9. Final Assessment
10. Annex I – ESRs
11. Conformity Assessment Modules
12. Documentation – General Guideline
13. Questions and Answers

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Pressure Equipment Directive 97/23/EC

PED Coverage
 Began Transition period 29 November 1999
 Became Mandatory from 29 May 2002
 Applies to Pressure Vessels, Piping, and Pressure and Safety Accessories

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Pressure Equipment Directive 97/23/EC

Where to find information


 Pressure Equipment Sector homepage in European Commission
http://ec.europa.eu/enterprise/sectors/pressure-and-gas/documents/ped/index_en.htm
 231 Guidelines help in interpreting the PED
1. Scope and exclusions of the directive
2. Classification and categories
3. Assemblies
4. Evaluation assessment procedures
5. Interpretation of the essential requirements on design
6. Interpretation of the essential requirements on manufacturing
7. Interpretation of the essential requirements on materials
8. Interpretation of other essential requirements
9. Miscellaneous
10. General/Horizontal issues

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Scope and Definition

1. New Approach and Global Approach


2. EU Product Directive/ CE Marking
3. Pressure Equipment Directive 97/23/EC (PED)
4. Scope and Definition
5. Classification
6. Materials
7. Welding
8. NDE
9. Final Assessment
10. Annex I – ESRs
11. Conformity Assessment Modules
12. Documentation – General Guideline
13. Questions and Answers

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Scope and Definition

The PE Directive applies to:

 The design, manufacture and conformity assessment of pressure equipment and


assemblies with a maximum allowable pressure (PS) greater than 0,5 bar
 Every type of pressure equipment is covered if not specifically listed as excluded
in Article 1, Sec. 3 (items 3.1 to 3.21)
 Also (as for all other directives) does not cover “in-service” (guideline 1/3)

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Scope and Definition

 'Pressure equipment` means vessels, piping, safety accessories and pressure


accessories. Where applicable, pressure equipment includes elements attached to
pressurized parts, such as flanges, nozzles, couplings, supports, lifting lugs, etc.
 'Vessel` means a housing designed and built to contain fluids under pressure
including its direct attachments up to the coupling point connecting it to other
equipment. A vessel may be composed of more than one chamber. (article 3/9,
guideline 2/19)
 'Piping` means piping components intended for the transport of fluids, when
connected together for integration into a pressure system. Piping includes in
particular a pipe or system of pipes, tubing, fittings, expansion joints, hoses, or
other pressure-bearing components as appropriate. Heat exchangers consisting of
pipes for the purpose of cooling or heating air shall be considered as piping.
(guideline2/4)

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Scope and Definition

 'Safety accessories` means devices designed to protect pressure equipment


against the allowable limits being exceeded. Such devices include: devices for
direct pressure limitation, such as safety valves, bursting disc safety devices,
buckling rods, controlled safety pressure relief systems (CSPRS), and limiting
devices, which either activate the means for correction or provide for shutdown or
shutdown and lockout, such as pressure switches or temperature switches or fluid
level switches and 'safety related measurement control and regulation (SRMCR)`
devices.

Note:
Safety Accessories are normally Category IV. If purchased, should be CE marked by device manufacturer
(97/23/EC Annex II, cl 2)
EN ISO EN ISO 4126-1, Safety devices for protection against excessive pressure — Part 1: Safety valves
EN ISO EN ISO 4126-3, Safety devices for protection against excessive pressure — Part 3: Safety valves and bursting
disc safety devices in combination
EN 764-7, Safety systems for unfired pressure equipment

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Scope and Definition

 'Pressure accessories` means devices with an operational function and having


pressure-bearing housings. (valves, meters, etc.)
 'Assemblies` means several pieces of pressure equipment assembled by a
manufacturer to constitute an integrated and functional whole.

Example for Assembly


Boiler  Assemblies
The means of providing the boiler with feed water and the means of preparing and
feeding the fuel to the boiler are not part of this minimum assembly. They can bear
a CE marking separately or be integrated in the assembly if the manufacturer
wishes so.
EN 12952 series (guideline 3/4)

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Scope and Definition

 Flanges, fittings, plain pipe lengths, heads and other equipment that don’t have
an identifiable pressure housing (such as Thermowells) are considered as
“components” of pressure equipment and not equipment themselves, so they can
not be CE marked for compliance with PED. (guideline 4/9, 7/19)

Example for components of pressure equipment


cover, collar, gasket, flange, bolt : “components” of pressure equipment
Question: What guidance can be given regarding the application of the Directive to component parts of pressure equipment
such as flanges, dished ends and nozzles ?
Answer: If these component parts are incorporated to an item of pressure equipment, the relevant requirements of the
directive will apply.
However, these component parts do not meet the definition of pressure equipment in Article 1.2.1, therefore they shall not
bear the CE mark.
It is the responsibility of the pressure equipment manufacturer to ensure that the component parts enable the pressure
equipment to meet the essential safety requirements of the directive. (guideline 1/22)

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Scope and Definition

Case study I
 safety valve  safety accessory
 cover, collar, gasket, flange, bolt  components of a pressure equipment
 sight glass with its frames  components of a pressure equipment
 flanges, fittings, plain pipe lengths  components of a pressure equipment
 thermowells  components of a pressure equipment
 valves, meters  pressure accessory
 connecting together piping components (flanges, pipes, fittings, reducers for
example)  item of piping (guideline 2/31)

Note: Related standards


Standard joints at CEN level:<Harmonized standards>
EN 1092 standards for PN designated flanges / EN 1759 – 3 / 4 standards for class designated flanges

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Scope and Definition

Case study II

 pressure cookers, portable extinguishers, breathing apparatus, skid mounted


systems, autoclaves; air conditioner, compressed air supply in a factory,
refrigerating system, shell boilers, water tube boilers, distillation, evaporation or
filtering units in process plants, oil heating furnaces  assemblies (guideline 3/8)

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Scope and Definition

Notable Exclusions: (from Article 1, Section 3)


 Simple pressure vessel (SPVD), e.g portable air compressor
 Items specifically designed for nuclear use, failure of which may cause an
emission of radioactivity;
 Pressure equipment consisting of a flexible casing, e.g. tyres, air cushions, balls
used for play, inflatable craft, and other similar pressure equipment
 Transmission pipelines to or from an installation (onshore or offshore), but
includes compression or pressure reduction stations
 Radiators and pipes in warm water heating systems
 Public water distribution networks

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Classification

1. New Approach and Global Approach


2. EU Product Directive/ CE Marking
3. Pressure Equipment Directive 97/23/EC (PED)
4. Scope and Definition
5. Classification
6. Materials
7. Welding
8. NDE
9. Final Assessment
10. Annex I – ESRs
11. Conformity Assessment Modules
12. Documentation – General Guideline
13. Questions and Answers

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Classification

 Pressure equipment shall be classified by category in accordance with Annex II,


according to ascending level of hazard

 Most vessels and piping are classified on the basis of:


– their maximum allowable pressure (PS), and
– their volume V or their nominal size (DN), as appropriate, and
– the group of fluids for which they are intended,

Nominal Size (DN) means a numerical designation of size which is common to all
components in a piping system other than components indicated by outside
diameters or by thread size.

Note: Consideration Volume and DN


In some cases both volume and DN are considered appropriate. In such cases, the pressure accessory must be
classified in the highest category.
In the case of valves, DN is normally the more appropriate.(guideline 2/17)

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Classification

Classification of fluid group

Group 1 Group 2

 Explosive All other fluids, including steam


 Extremely flammable
 Highly flammable
 Flammable
 Very toxic
 Toxic
 Oxidizing
(guideline 2/7)

Commission Directive 2001/59/EC adapting to Council Directive 67/548/EEC


relating to the classification, packaging and labelling of dangerous substances
http://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexapi!prod!CELEXnumdoc&lg=en&numdoc=32001L0059&model=guichett

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Classification

Classification of fluid group

VESSELS STEAM PIPING


GENERATORS

State of Gas Liquid Gas Liquid


Contents
or liquid whose or liquid
vapour whose vapour
pressure> 0,5 pressure> 0,5
at TS at TS

Fluid Dang Oth. Dang Oth. Dang Oth. Dang Oth.


Group

Refer to Table Table Table Table Table 5 Table Table Table Table
table 1 2 3 4 6 7 8 9

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Classification

Article 3.3 products


 Pressure equipment and/or assemblies below or equal to the limits in sections 1.1, 1.2 and
1.3 and section 2 respectively must be designed and manufactured in accordance with the
sound engineering practice of a Member State in order to ensure safe use. Pressure
equipment and/or assemblies must be accompanied by adequate instructions for use and
must bear markings to permit identification of the manufacturer or of his authorized
representative established within the Community. Such equipment and/or assemblies must
not bear the CE marking referred to in Article 15.

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Classification

Table 1
Vessel for Group 1 gases or liquid
whose vapour pressure at the maximum
allowable temperature is greater than
0,5 bar above normal atmospheric
pressure

Unstable gas and falling within


categories I or II on the basis of Table
1, must be classified in category III

Typical examples of unstable gases: acetylene


(UN 1001), methyl acetylene (UN 1060),
vinylfluoride (UN 1860). Refer to Directive
67/548/EEC (guideline 2/21)

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Classification

Table 2

Vessels for Group 2 gases or liquid


whose vapour pressure at the maximum
allowable temperature is greater than
0,5 bar above normal atmospheric
pressure

Portable extinguishers and bottles for


breathing equipment must be classified
at least in category III

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Classification

Table 3

Vessels for Group 1 liquid whose vapour


pressure at the maximum allowable
temperature is not greater than 0,5 bar
above normal atmospheric pressure

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Classification

Table 4

Vessels for Group 2 liquid whose vapour


pressure at the maximum allowable
temperature is not greater than 0,5 bar
above normal atmospheric pressure

Assemblies intended for generating


warm water at temperatures not greater
than 110°C, which are manually fed with
solid fuels and have a product or
pressure and volume greater the 50 bar
litres must be subjected to either Module
B1 (for ESR’s 2.10, 2.11, 3.4, 5 (a) (b),
or Module H

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Classification

Table 5
Steam Generators

The design of pressure cookers must be


subject to a conformity assessment
procedure equivalent to at least one of
the category III modules

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Classification

Table 6

Piping for Group 1 gases or liquid


whose vapour pressure at the
maximum allowable temperature is
greater than 0,5 bar above normal
atmospheric pressure

Unstable gas and falling within


categories I and II must be classified
in category III

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Classification

Table 7

Piping for Group 2 gases or liquid whose


vapour pressure at the maximum allowable
temperature is greater than 0,5 bar above
normal atmospheric pressure

All piping containing fluids at a temperature


greater than 350°C and falling within
category II must be classified in category III

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Classification

Table 8
Piping for Group 1 Liquids

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Classification

Table 9
Piping for Group 2 Liquids

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Classification

Case Study III

Determine the equipment category within PED (annex II) for the following
equipment:

Equipment: Well production test separator


Pressure: 350 PSI (24.13 bar)
Volume: 200 Gallon (757 litre)
Contents: Group 1 fluid

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Classification

Case Study III

Evaluation Information:
Equipment Type = Vessel
Fluid state: = Liquid & Gas
Fluid group: =1
Annex II table =1
PS x V = 18,266 (24.13 x 757)

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Classification

Case Study III

PS = 24.13 bar

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49
Classification

Case Study III

PS = 24.13
V = 757 Litre

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Classification

Case Study III

PS x V = 18,266
PS x V > 1000

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Classification

Case Study III

PS x V = 18,266
PS x V > 1000

= category IV

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Materials

1. New Approach and Global Approach


2. EU Product Directive/ CE Marking
3. Pressure Equipment Directive 97/23/EC (PED)
4. Scope and Definition
5. Classification
6. Materials
7. Welding
8. NDE
9. Final Assessment
10. Annex I – ESRs
11. Conformity Assessment Modules
12. Documentation – General Guideline
13. Questions and Answers

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Materials

Manufacturing Requirements

Designer must select materials that are suitable for the expected application and
intended lifetime

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Materials

Provide list of materials Materials


that demonstrates source:
Harmonized
Standard

Materials European Approval


of Material

Particular Material
Appraisal

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Materials

Harmonised Standards
EN 10213 Pt 1
EN 10213 Pt 2 Steel castings
EN 10028 Pt 1 EN 10213 Pt 3
EN 10028 Pt 2 EN 10213 Pt 4
EN 10028 Pt 3
EN 10028 Pt 4 Steel Plates
EN 10028 Pt 5 EN 10222 Pt 1
EN 10028 Pt 6 EN 10222 Pt 2
EN 10028 Pt 7 EN 10222 Pt 3 Steel forging
EN 10222 Pt 4
EN 10269 EN 10222 Pt 5
Fasteners

EN 12482 Aluminium
EN 12420
EN 12451 Copper EN 10216 Seamless &
EN 12452 EN 10217 welded tubes

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Materials

EAM

European Approval of Materials is a technical document defining the characteristics of


materials intended for repeated use in the manufacture of pressure equipment the type of which
is NOT already covered by a harmonised standard. Notified bodies issue these documents. The
notified body shall determine and perform the appropriate inspections and tests to certify the
conformity of the types of material with the corresponding requirements of the PED.

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Materials

Particular Material Appraisal (PMA)is the process by which the manufacturer


ensures that each proposed material (that is not in a harmonized standard or
covered by EAM) is:
 Conforms to the applicable Essential Safety Requirements, or;
 Achieves an “equivalent level of safety” to ESR’s
 For pressure equipment in Category III and IV, a Notified Body must also perform
this appraisal

NOTE: It is always the manufacturer’s responsibility to confirm the material is suitable for it’s intended use.

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Materials

Main issues concerning PMA’s

Approval of ASME materials for use with PED:


 Impact toughness
 Ductility
 Forming- and welding
 Not affected by ageing

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Materials

Manufacturing Requirements

Approval of ASME materials for use with PED:


Generally, ASME/ ASTM materials for use, through particular material appraisal
when:
 Materials supplied meet mechanical requirements of PED (where appropriate)
 ASME or suitable recognized design and fabrication code is used in it’s entirety
 ASME welding procedures are used, often in conjunction with EN ISO 15614
series supplemental testing.

NOTE: Some Notified Bodies will not accept ASME material properties or chemistry

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Materials

PMA Example

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Materials

Manufacturing Requirements
Materials must have appropriate properties for all reasonably foreseeable operating
and test conditions, in particular concerning ductility and toughness. Where
appropriate, material characteristics should meet: (accordance with 97/23/EC
Annex I clause 4 and clause 7.5)
 Elongation after rupture exceeds 14%
 Charpy impact energy is not less that 27J, at temperature not higher than lowest
scheduled operating temperature, but not higher than 20°C
 Sufficiently chemically resistant to the fluid contained in the equipment
 Not sufficiently affected by ageing
 Suitable for the intended processing procedures
 Selected in order to avoid significant undesirable effects when put together with
other materials

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Materials

Material Documentation

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Materials

Case Study IV

Who is responsible for the PMA?

For PED Category I and II, the PMA is under the responsibility of the
equipment manufacturer

For PED Category III and IV, the PMA is appraised by the nominated
Notified Body

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Welding

1. New Approach and Global Approach


2. EU Product Directive/ CE Marking
3. Pressure Equipment Directive 97/23/EC (PED)
4. Scope and Definition
5. Classification
6. Materials
7. Welding
8. NDE
9. Final Assessment
10. Annex I – ESRs
11. Conformity Assessment Modules
12. Documentation – General Guideline
13. Questions and Answers

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Welding

Welding (joining) Procedures

 The properties of welded joints must meet the minimum properties for the base
materials joined
 Welding procedures must be supported with qualification tests
 Welding procedures and personnel for (pressure welds) on Category II, III
and IV equipment must be approved by either a Notified Body or a Recognized
Third Party Organisation (Annex I 3.1.2)

NOTE: Third Party Organizations may appoint organisations according to Article 13 of the Directive, for specific tasks
related to approval of welding procedures, personnel, and NDE operators. These appointments are listed with the
Commission, in the same way as Notified Body appointment.
WQ= Welder Qualification
WPS= Welding Procedure Specification
PQR= Procedure Qualification Record

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Welding

Welding Consumables (guideline 7/12)


 Manufacturers of welding consumables shall provide inspection documents
affirming compliance with the specification.
 Based on section 4 of Annex I and guideline 7/5 manufacturers of welding
consumables shall provide test report "2.2" as an inspection document in
accordance with the standard EN 10204.
 The traceability requirement of Annex I section 3.1.5 applies also for welding
consumables. It can be maintained by procedural methods that cover receipt,
identification, storage, transfer to production, temporary storage and use in
production, availability of correct inspection documents at the final inspection (see
also guideline 7/4).

NOTE :Welding consumables are treated as materials and must fulfil the relevant requirements of: 4.1, 4.2(a),
4.3 First paragraph, Certificate of conformance required
Welding consumables are defined by trade name, designation and relevant EN classification standard.
Inspection documents of welding consumables should give test results, for technical characteristics
according to designation and classification standard, such as:
 Chemical composition of welding filler metal or all-weld metal as appropriate
 Tensile properties of all-weld metal: tensile and yield strength, elongation
 Impact properties of all-weld metal at temperature according to designation. Test results are based on non
specific inspection and testing. They can be given for example as typical values based on quality control
tests.

67 DNV GL © 2013
Welding

Welding (joining) Procedures

 Welding procedures and personnel qualifications are normally to be in accordance


with Harmonized Standards, such as EN 287 (Qualification test of welders)/ EN
ISO 15614 (Specification and qualification of welding procedure), or equivalent
standards. (guideline 6/8)
 When Notified Body approval is required, the Notified Body is responsible to
determine the extent with which they must witness or conduct the appropriate
tests. (guideline 6/1)

Note: EN ISO 15614-1 replaced EN 288-3 (Specification and approval of welding procedures for metallic materials )
EN 287-1 was to be replaced by EN ISO 9606-1, but agreement could not be reached.

68 DNV GL © 2013
NDE

1. New Approach and Global Approach


2. EU Product Directive
3. Pressure Equipment Directive 97/23/EC (PED)
4. Scope and Definition
5. Classification
6. Materials
7. Welding
8. NDE
9. Final Assessment
10. Annex I – ESRs
11. Conformity Assessment Modules
12. Documentation – General Guideline
13. Questions and Answers

69 DNV GL © 2013
NDE

NDE Operator Qualification

 NDE Operators must be approved by a third-party organization recognized (RTPO)


by a Member State for Category III and IV equipment.
 EN ISO 9712: specifies qualification and certification requirements for NDE
personnel
 Harmonised standard for NDT operator qualification to PED: EN ISO 9712

NOTE: Operators with certificates from other schemes than EN ISO 9712 will in most cases not be approved by a RTPO

70 DNV GL © 2013
Final Assessment

1. New Approach and Global Approach


2. EU Product Directive/ CE Marking
3. Pressure Equipment Directive 97/23/EC (PED)
4. Scope and Definition
5. Classification
6. Materials
7. Welding
8. NDE
9. Final Assessment
10. Annex I – ESRs
11. Conformity Assessment Modules
12. Documentation – General Guideline
13. Questions and Answers

71 DNV GL © 2013
Final Assessment

Final Assessment: Inspection and Testing

Final Inspection
 Equipment must undergo a final inspection and documentation review. Final
inspection must be carried out internally and externally on every part of the
equipment (at the appropriate stage of manufacturing).

72 DNV GL © 2013
Final Assessment

Final Assessment: Inspection and Testing


Testing:
Final assessment of equipment must include be pressure testing:
 Hydrostatic testing
PT  1,43PS
and whichever is greater
fa
Pt  1,25 PS 
f ts
 If hydrostatic testing is harmful or impractical, other recognized tests may be
carried out, but may require additional NDE to be carried out. (e.g.. pneumatic
pressure test guideline 8/16)
Pt is the test pressure measured at the highest point of the vessel in test position;
Ps is the maximum allowable pressure of the vessel;
fa is the nominal design stress for normal operating load cases of the part at test temperature;
fts is the nominal design stress for normal operating load cases of the part at maximum allowable temperature;
Pt , Ps , fa and fts shall have consistent units.

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Final Assessment

Final Assessment: Applying harmonised standards

EN 13445 series: Unfired pressure vessels


EN 13445-5
Unfired pressure vessels — Part 5: Inspection and testing

EN 13480 series: Metallic industrial piping


EN 13480-5
Metallic industrial piping — Part 5: Inspection and testing

74 DNV GL © 2013
Annex I - ESRs

1. New Approach and Global Approach


2. EU Product Directive/ CE Marking
3. Pressure Equipment Directive 97/23/EC (PED)
4. Scope and Definition
5. Classification
6. Materials
7. Welding
8. NDE
9. Final Assessment
10. Annex I – ESRs
11. Conformity Assessment Modules
12. Documentation – General Guideline
13. Questions and Answers

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Annex I - ESRs

General Requirements

 Eliminate or reduce hazards


 Apply protective measures for hazards not eliminated
 Inform users of residual hazards and required special measures necessary
 Design to prevent danger from known or clearly foreseeable misuse

The manufacturer is under an obligation to analyse the hazards, in order to identify those which apply to his equipment;
the he must design and construct it taking account of his analysis.

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Annex I - ESRs

Hazard Analysis

Start

Determine
Equipment
Boundaries

Identification Risk Reduction


of Hazards

No

Is
Risk
Evaluation
Equipment
Safe? Yes
END

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Annex I - ESRs

General Design Requirements

Design for Adequate Strength: (loading appropriate to intended use, including):


 Internal/external pressure
 Ambient and operating temperatures
 Static pressure and mass of contents in operating and test conditions
 Traffic, wind, earthquake loading
 Reaction forces and moments which result from the supports, attachments,
piping, etc.
 Corrosion and erosion, fatigue, etc.
 Decomposition of unstable fluids
 Various loading which can occur at the same time must be considered

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Annex I - ESRs

Design Requirements
Two methods for adequate design strength:

Calculation Method: (ref. 2.2.3)


Allowable stresses must be limited having regard to reasonably foreseeable failure
modes under operating conditions. Safety factors must be applied. Requirements
may be met by applying one or more of the following methods:
 design by formula
 design by analysis
 design by fracture mechanics

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Annex I - ESRs

Design Requirements

Experimental Design Method (ref. 2.2.4)


Allowed when the PS x V is less that 6000 bar/L, or PS x DN is less than 3000 bar
Design may be validated all, or in part by an appropriate test program, carried out
on a representative sample of the equipment or category of the equipment. The
test program must include:
 A pressure strength test, at a pressure with a defined safety margin in relation to
MAP
 Appropriate tests when risk of creep or fatigue exists (determined on the basis of
service conditions)
 Additional factors identified in General Design Requirements (2.1.1)

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Annex I - ESRs

Design Requirements

 Adequate means of draining and venting (2.5)


 Adequate allowance for corrosions or chemical attack (2.6)
 Wear (2.7)
 Suitable components when used on assemblies (2.8)
 Provisions for filling and discharging (2.9)
 Protection against exceeding the allowable limits(2.10)

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Annex I - ESRs

Provisions to ensure safe handling and operation

Particular attention must be paid to:


 closures and openings
 dangerous discharge of pressure relief blow-off
 devices to prevent physical access while pressure or vacuum exists
 surface temperature taking into consideration the intended use
 decomposition of unstable fluids
 pressure equipment with an access door must be equipped with a device enabling
the user to easily ascertain that the opening will not present any hazards and, if
the device can be operated quickly, a device to prevent it being opened whenever
pressure or temperature of fluids presents a hazard.

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Annex I - ESRs

Safety Accessories

 Must be designed and constructed to be reliable and suitable for the intended
duty: SIL (safety integrity level)
 Be independent of other functions
 Comply with appropriate design principles, such as, fail-safe modes, redundancy,
diversity and self-diagnosis
 Pressure limiting devices must not allow the equipment to see short duration
pressure surge exceeding 10% of allowable working pressure.
 Temperature monitoring devices must have an adequate response time,
consistent with the measurement function.

Note: Safety Devices are normally Category IV. If purchased, should be CE marked by device manufacturer

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Annex I - ESRs

Marking and Labelling


Marking requirements:
 Manufacturer’s name, address
 Year of manufacture
 Identification according to it’s nature,(type, series, serial no., etc.)
 Essential min/max allowable limits

Further information as necessary for safe installation, operation, maintenance,


periodic inspection, etc.:
 Volume (in litre)
 Nominal size (for piping, piping accessories)
 test pressure
 Safety device set pressure
 Tare mass (in kg)
 Maximum filling mass (in kg)

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Annex I - ESRs

Operating Instructions

Equipment placed on the market must be accompanied by instructions for use,


including:
 Information necessary for safe, mounting/assembly of pressure equipment,
putting into service, use, maintenance
 Instructions must cover information affixed to the equipment, including drawing,
diagrams, etc. as need to understand the instructions
 Hazards arising from misuse, limitations, etc.
 Although not specifically mentioned in the Directive, the instructions must be in
an official EU language, and in the language of intended use.

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Conformity Assessment Modules

1. New Approach and Global Approach


2. EU Product Directive/ CE Marking
3. Pressure Equipment Directive 97/23/EC (PED)
4. Scope and Definition
5. Classification
6. Materials
7. Welding
8. NDE
9. Final Assessment
10. Annex I – ESRs
11. Conformity Assessment Modules
12. Documentation – General Guideline
13. Questions and Answers

87 DNV GL © 2013
Conformity Assessment Modules

Module for
Conformity Assessment Process
Type Pressure Equipment Category Conformity
per Annex III of the PED
Assessment
I A Internal Process Control
Internal Process Control with Monitoring
A1
Piping by Notified Body
II D1 Production Quality Assurance
E1 Product Quality Assurance
B1+D EC Design Production Quality Assurance
E.g.
Pressure B1+F Examination + Product Verification
and Breathing Equipment

Vessels, III B+E Product Quality Assurance


Portable Extinguishers

Pressure EC Type
Accessories, B+C1 Examination + Conformity to Type
Pressure
H Comprehensive Quality Assurance
Assemblies
B+D EC Type Production Quality Assurance
Examination +
Accessories

B+F Product Verification


Safety

IV G EC Individual Testing
Full Quality Assurance with Design Examination
H1 and Special Surveillance of the Final Product
examination

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Documentation – General Guideline

1. New Approach and Global Approach


2. EU Product Directive/ CE Marking
3. Pressure Equipment Directive 97/23/EC (PED)
4. Scope and Definition
5. Classification
6. Materials
7. Welding
8. NDE
9. Final Assessment
10. Annex I – ESRs
11. Conformity Assessment Modules
12. Documentation – General Guideline
13. Questions and Answers

89 DNV GL © 2013
TCF Content – Design Review

ESR-EVALUATION
RISK ANALYSIS
To be drawn up if non harmonised
standards are used
TECHNICAL SPECIFICATION
Description of the pressure equipment DRAWINGS
- Pressure (Highest/lowest) Shall contain information showing:
- Temperature (Highest/lowest) - All manufacturing details
- Volume - Joint efficiencies
- Fluid (Specification, Fluid group, Density) - Marking plate
Following information can be presented
on the drawings alternative on separate
documentation:
- WPS
- Forming procedures
CALCULATIONS - Heat treatment
Description of the relevant load cases: - Coating&Painting
- Fatigue (Number of/allowable number of load - Brazing
cycles) - Inspection schedule
- Creep (Max operation time in creep range) - Tests to be done
- Static loads - Materials
- Dynamic loads - Marking of welds
Design Standard and Method
Special regulations
Customer Specifications

90 DNV GL © 2013
TCF Content – Manufacture Control

MATERIAL CERTIFICATION INFORMATION SHOWING (IF WPS


Including welding NOT SHOWN ON DRAWINGS) Approved by
consumables - WPS NB/RTPO for Cat II,
- Forming procedures III and IV
- Heat treatment
- Coating & Painting
PMA
- Brazing LIST OF WELDERS
If non-harmonised
- Inspection schedule and Approved by
standard materials are
record NB/RTPO for Cat II,
used
- Tests to be done III and IV
- Materials
TEST REPORTS - Marking of welds
NDT-RECORDS
NDT-operators shall
be approved by RTPO
PROOF TEST REPORT for Cat III and IV
Inclusive proof test
procedure

OPERATION MANUAL

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Assemblies - Documentation

1. P & ID
 P & ID should as a minimum include:
– document number
– document revision
– tag on equipment
– flow direction
– reference to other P & ID
– specification on piping
– shutdown functions
– control system should be comprehensible
– position on valves in normal operation
– Legend/ symbol description
2. Piping specification/ design pressure and temperature for the piping used
3. Flexibility analysis of the piping system

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Assemblies - Documentation

5. Process datasheet for Pressure Relieving Devices or any other form which
includes information about required rate, set pressure and maximum allowable
overpressure
6. Risk analysis/ HAZOP/ Safety Analysis Tables
7. Vendor documentation on Pressure Relieving Device including relieving rate and
maximum allowable pressure
8. Line sizing calculation upstream and downstream of Pressure Relieving Devices
according to EN 764, Part 7, Section 8.2.2 and 8.2.3 or equivalent
9. If not shown on the P & ID the ESD system is needed and in addition the cause
and effect diagram
10.Functionality description of the system
11.Piping isometric drawings - composite & detailed

93 DNV GL © 2013
TCF Content

General condition on all documentation:

Traceability!

94 DNV GL © 2013
Questions

1. New Approach and Global Approach


2. EU Product Directive/ CE Marking
3. Pressure Equipment Directive 97/23/EC (PED)
4. Scope and Definition
5. Classification
6. Materials
7. Welding
8. NDE
9. Final Assessment
10. Annex I – ESRs
11. Conformity Assessment Modules
12. Documentation – General Guideline
13. Questions and Answers

95 DNV GL © 2013
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96 DNV GL © 2013

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