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Standardisointi
TAIEX workshop 12.4.05 Bratislava
Implementation of the Pressure Equipment directive, PED
PED - modules and WP- Guidelines
Anja-Leena Tyry
StandardisointiA-L Tyry
SUB - topics:
• What PED, Why and Which modules ?
• Who decides, how ?
• Structure of modules, rules
• Guidelines: WPG, others
• Information …..
StandardisointiA-L Tyry
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
StandardisointiA-L TyryP E D Pressure Equipment Directive.What,which
module ?
StandardisointiA-L Tyry
CONFORMITY ASSESSMENT via MODULES
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 !
PED Article 10
Because we in EU want to have safe products which can move freely. OK ?
StandardisointiA-L Tyry
CONFORMITY ASSESSMENT
TO SELECT THE ”BEST” CONFORMITY ASSESSMENT PROCEDURE:
1 You (manufacturer) must know the category of the product :
BUT
2 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.. )
StandardisointiA-L Tyry
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.”
StandardisointiA-L Tyry
CATEGORIES & MODULES
CATEGORY I MODULE A
CATEGORY II MODULE A 1
D1E1
CATEGORY III MODULE B1 +DB1+FB + FB + C1H
CATEGORY IV MODULE B+DB + F
GH
PED Annex III
OK TO USE A HIGHER CATEGORY´S MODULE => WPG 2/11
Cannot be changed like modules!
StandardisointiA-L Tyry
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
M makes tech. papers 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 FIAS by M, NB monitors
StandardisointiA-L Tyry
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
M makes the tech.documentation
- as above at E -
StandardisointiA-L Tyry
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
StandardisointiA-L Tyry
MODULES, text from PED, Annex III , e.g.:
Module A (internal production control)
1. 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.
StandardisointiA-L Tyry
2. 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.
StandardisointiA-L Tyry
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: …
StandardisointiA-L Tyry
http://ped.eurodyn.com/
StandardisointiA-L Tyry
Guideline 4/5 Final version as adopted on 26 June 2001Pressure 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
StandardisointiA-L Tyry
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: 2001-04-23Accepted by Working Group pressure on : 2001.06.26
StandardisointiA-L Tyry
Guideline 4/6 Final version as adopted on 7 November 2000, Pressure equipment directive 97/23/ECCommission’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
StandardisointiA-L Tyry
Guideline 4/8Final version as adopted on 26 June 2001Pressure 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
StandardisointiA-L Tyry
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 ).
StandardisointiA-L Tyry
LINKS: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
StandardisointiA-L Tyry
Kiitos ! Kysyttävää?32 altsyys03
Kiitos ! Kysyttävää?GSM +358 40 545 9719