TAIEX workshop 12.4.05 Bratislava Implementation of the Pressure Equipment directive, PED PED - modules and WP- Guidelines Anja-Leena Tyry

SUB - topics: What PED, Why and Which modules ? Who decides, how ? Structure of modules, rules Guidelines: WPG, others Information …..

Techology Industries of Finland (MET), Standards 2005: Persons: 8 (9)+1: mostly in Helsinki, Finland secretary Tiia Ryhänen, Arne Hülphers (Piping), Carl-Gustaf Lindewald (NDT), Mika Vartiainen (Matr), Anja-Leena Tyry (PED, Tampere), Antti Karppinen (boss,Mater), Arto Kivirinta, Toivo Haatio, Jorma Railio, Aarre Viljanen (Brussels). We make and keep up this year: 100 standards in Finnish (SFS-ISO-EN...,etc) 2000 pages and 20 Handbooks e-publications, seminars e-delivered dokuments, netpages incl Internet-publications - OnLine database

P E D Pressure Equipment Directive.What,which module ?

CONFORMITY ASSESSMENT via MODULES PED Article 10 WHY AN ASSESSMENT SYSTEM IS NEEDED ? because it is so easy to interpret or understand wrongly because we ”interpret” in different ways (so called culture) < = > 200 Guidelines needed ! Because we in EU want to have safe products which can move freely. OK ?

CONFORMITY ASSESSMENT TO SELECT THE ”BEST” CONFORMITY ASSESSMENT PROCEDURE: You (manufacturer) must know the category of the product : BUT The customer (perhaps a Notified Body?) might have special needs and wants a certain other category to the product. Not OK ! ( local habits, traditions, inspectors guidance,…, easier for the futher production, special fluid.. )

PED, recital 19 (the pre-text in the directive): MODULES PED, recital 19 (the pre-text in the directive): ”…in view of the nature of hazards involved in the use of PE, it is necessary to establish procedures for assessing compliance with the basic requirements of the directive …” => MODULES ”…procedures must be devised (designed) in the light of (taking into consideration) the level of danger which is inherent (permanent) in the PE ” => CATEGORIES recital 26: ”…requirements laid down in Annexes…, to allow all users incl. SMS to comply with them easily.”

CATEGORIES & MODULES PED Annex III CATEGORY I MODULE A CATEGORY II D1 E1 CATEGORY III MODULE B1 +D B1+F B + F B + C1 H CATEGORY IV MODULE B+D B + F G H Cannot be changed like modules! OK TO USE A HIGHER CATEGORY´S MODULE => WPG 2/11

THE 13 MODULES of PED: 1 - 5 DC = declaration of conformity, FIAS = final assessment M = manufacturer, NB = notified body Procedure for Design for Manufacturing A Internal production control M makes tech. papers FIAS by M A1 =A+ monitrng of FIAS FIAS by M, NB monitors B EC-type examination NB examines the conformity of the type use C1, D , E or F B1 EC-design examination NB examines the conformity of the design use D or F C1 Conformity to type EC type-examination

THE 13 MODULES of PED: 6 - 9 DC = declaration of conformity, FIAS = final assessment M= manufacturer, NB=notified body Procedure for Design for Manufacturing D Production quality assurance EC type - (B) or design-examination (B1) M applies in production, testing and FIAS a Quality system, which is approved by accredited body and then approval by the NB D1 Production quality assurance M makes the tech.documentation - as above at D - E Product quality assurance EC type-examination (B) - as above at D, but not in production E1 Product quality assurance - as above at E -

THE 13 MODULES of PED: 10 -13 DC = declaration of conformity, FIAS = final assessment M= manufacturer, NB=notified body Procedure for Design for Manufacturing F Product verification EC type - (B) or design-examntion (B1) NB makes the FIAS of every product G EC unit verification NB makes the FIAS of the design and of the manufacturing H Full quality assurance M applies in design, production, testing and for FIAS a Quality system, which is approved and controlled by the NB H1 Product quality assurance - as above at H plus: the NB makes the design-examination and monitors FIAS

MODULES, text from PED, Annex III , e.g.: Module A (internal production control) This module describes the procedure whereby the manufacturer,or his authorized representative established within the Community, who carries out the obligations laid down in section 2, ensures and declares, that pressure equipment satisfies the requirements of the Directive which apply to it. The manufacturer, or his authorized representative established within the Community, must affix the CE marking to each item of pressure equipment and draw up a written declaration of conformity.

The manufacturer must: - draw up the technical documentation described in section 3 - and either the manufacturer or his authorized representative established within the Community must keep it at the disposal of the relevant national authorities for inspection purposes for a period of ten years after the last of the pressure equipment has been manufactured. Where neither the manufacturer nor his authorized representative is established within the Community, the obligation to keep the technical documentation available is the responsibility of the person who places the pressure equipment on the Community market.

3. The technical documentation must enable an assessment to be made of the conformity of the pressure equipment with the requirements of the Directive which apply to it. It must, as far as is relevant for such assessment, cover the design, manufacture and operation of the pressure equipment and contain: …

http://ped.eurodyn.com/

Guideline related to: Annex III, module B1 Guideline 4/5 Final version as adopted on 26 June 2001 Pressure equipment directive 97/23/EC Commission’s WGP page1/2 Guideline related to: Annex III, module B1 Question: Clauses 3 and 4 of module B1 in Annex III deal with information concerning qualifications or approvals of permanent joining that may not be available at the design stage. What are the minimum requirements in clause 3, last indent, and clause 4.1, 2nd and 3rd indents? Answer: Approval of operating procedures for permanent joining shall be made at the design stage, if not previously approved

page2/2 For the personnel performing permanent joining and non-destructive tests, the requirement at the design stage may be limited to the verification of the criteria for qualifications or approvals. The need to perform the personnel approval verification at a later date before start of production should be pointed out in the design examination certificate. See also guideline 4/4. Accepted by WPG on: 2001-04-23 Accepted by Working Group pressure on : 2001.06.26

Guideline related to : Article 10.2, Annex III Guideline 4/6 Final version as adopted on 7 November 2000, Pressure equipment directive 97/23/EC Commission’s Working Group ”Pressure” Guideline related to : Article 10.2, Annex III Question : Can an assembly be composed of pressure equipment dealt with using different conformity assessment modules ? Answer : Yes, by application of Article 10.2a). For example, the valves can have a module different from that applied to the vessel or the piping on which they are placed. Accepted by WPG on : 2000-08-25 Accepted by Working Group ” pressure ” on : 2000.11.07

Guideline related to: Annex III, B1, sections 4.2 and 4.3 Guideline 4/8 Final version as adopted on 26 June 2001 Pressure equipment directive 97/23/EC Commission’s WGP Guideline related to: Annex III, B1, sections 4.2 and 4.3 Question: Are tests by the notified body required for B1? Answer: No. In contrast to module B, module B1 consists solely of the examination of drawings, calculations and relevant information concerning manufacturing. The experimental design method may not be used in this module. There are no examinations or tests to be performed on a representative example of the production envisaged. See also guideline 4/5. NOTE : There is inconsistency in some language versions. Accepted by WPG on: 2001-04-23 Accepted by Working Group pressure on: 2001.06.26

Sources for PED- WPGuidelines e.g. : ORGALIME: also some which are not put into the Commission working group; www.orgalime.org Notified Bodies: originally for their own use, to ”level” the understanding of what is ok what is not ok. Some of these ”silent TRGs” will end up as WPG, - I belive ! National interpretations: eg. in Finland www.tukes.fi => Painelaitteet => Kysymyksiä ja vastauksia,( also WPGs are there ).

LINKS: SFS => EN 13445 MHD Issues-pages available http://www.techind.fi/standard/ => ISO , CEN and SFS => EN 13445 MHD Issues-pages available PED Text and Guidelines (hyperlinked) ,incl. Working party Guidelines: http://ped.eurodyn.com CEN - Standards: www.europa.eu.int/comm/enterprise/newapproach/standardization /harmstds/reflist/equippre.html CEN Website http://www.cenorm.be http://europa.eu.int/yourvoice/consultations/index_en.htm http:/www.cenorm.be/cenorm/workarea/sectorfora/ pressure+equipment/index.asp US ASME code: http://www.asme.org

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