Information Leaflet On Coming Up Changes In The European Pressure . - DNV
Information leaflet on coming up changes in the European Pressure Equipment Directive (PED), version 201626 Pressure equipment for the European market This information leaflet is a common publication of the DNV GL Conformity Assessment Bodies (CAB) for PED: - 1 Conformity Conformity Conformity Conformity Conformity Assessment Assessment Assessment Assessment Assessment Body Body Body Body Body nr. nr. nr. nr. nr. 0097 2388 0496 0575 2099 UK The Netherlands Italy Norway Denmark Introduction on new PED 2014/68/EU The Pressure Equipment Directive (PED 97/23/EC) has been in place since the 29th May 2002. It will be replaced by PED 2014/68/EU as per 19 July 2016. Two main factors have enforced the new PED The basis for the determination of fluid group (1 or 2) in PED Article 9 (i.e. Directive 67/548/EEC) has been replaced by a new Classification, Labelling and Packaging Regulation as per 1st June 2015. The “New Legal Framework:” This is a larger initiative by the European Union to bring nine EC “New Approach” directives into alignment with the “New Legal Framework,” (NLF) which was adopted in 2008. The essentials of the current PED will not change The scope of the PED The essential safety requirements (annex I) The categorisation tables (annex II) The introduction of the new PED will not act in retrospect on certificates issued under the existing PED. Article 48 states, “Certificates and decisions issued by conformity assessment bodies under Directive 97/23/EC shall be valid under this Directive.” Not only the PED changes, but also a number of other EU directives has been changed or will change, due to the new NLF, like: DNV GL Headquarters, Veritasveien 1, P.O.Box 300, 1322 Høvik, Norway. Tel: 47 67 57 99 00. www.dnvgl.com 2016/26 – DNV GL P. 1 / 18 ILPED201468EU-201626
Directive Products Revision PED 97/23/EC Pressure Equipment New PED (2014/68/EU) in force 19 July 2016 LD 95/16/EC Lifts New LD (2014/68/EU) in force 20 April 2016 R&TTE 99/5/EC Radio Equipment Replaced by new Radio Equipment Directive 2014/53/EC in force 13 June 2016 EMC 2004/108/EC Electromagnetic Compatibility New EMC (2014/30/EU) in force 20 April 2016 LVD 2006/95/EC Low Voltage New LVD (2014/35/EU) in force 20 April 2016 ATEX 94/9/EC Devices in Explosive Atmosphere New ATEX (2014/34/EU) in force 20 April 2016 RCD 94/25/EC Recreational Crafts New RCD (2013/53/EU) in force 18 January 2016 MID 96/98/EU Measurements Instruments New MID (2014/32/EU) in force 30 October 2016 DNV GL Headquarters, Veritasveien 1, P.O.Box 300, 1322 Høvik, Norway. Tel: 47 67 57 99 00. www.dnvgl.com 2016/26 – DNV GL P. 2 / 18 ILPED201468EU-201626
2 New PED Transfer process The dates below show the two timeline steps for the introduction of the new PED. 1 June 2015 19 July 2016 Art.13 of the new PED applies (i.e.CLP) Full application of the new PED All EU member states are required to transpose the new PED 2014/68/EU in their national legislation before these dates. 3 3.1 Changes in brief Economic operators The new PED defines the term “economic operators” defining roles and responsibilities as below Manufacturer – unchanged Authorized representative – unchanged Importer - The importer is the economic operator established in the Union who places a product from a third country on the Union market. The importer must ensure that the manufacturer has correctly fulfilled his obligations. The importer is not a simple re-seller of products, but has a key role to play in guaranteeing the compliance of imported products. He is obliged to contact the manufacturer if the compliance with the PED requirements are doubted. He must mark the product with his name and address. He must ensure that, while a product is under his responsibility, storage or transport conditions do not jeopardise its compliance. He must keep a copy of the EU Declaration of Conformity for 10 years after the product has been placed on the market and ensure that the technical documentation can be made available to the competent national authority upon request. Distributor- juridical/physical person in the EU in the supply chain between any of the above defined (both Third Country and inside the EU) and the User. Retailers, wholesalers and other distributors in the supply chain are not required to have a direct agreement with the manufacturer like the authorised representative. A distributor acquires products for further distribution either from a manufacturer, from an importer, or from another distributor. However they have an obligation to be aware of the PED requirements and their responsibility. They must keep a copy of the manufacturer’s operation manual and the DoC. The revision of the PED also makes clear that if an importer or distributor places pressure equipment or assemblies on the market under their own name or trademark, or modifies the equipment in a certain way, they will be considered manufacturer and will therefore have to take legal responsibility for the product’s compliance including conformity assessment. In the Netherlands the Ministry of Social Affairs has decided that a user who assembles pressure equipment into an assembly is in effect a manufacturer. The ministry has deleted the option for “samenbouw onder verantwoording van de gebruiker” and the user/manufacturer shall now assemble his pressure equipment according to the new PED 2014/68/EU, have an Notified Body involved according to a suitable conformity assessment module and CE mark the assembly. DNV GL Headquarters, Veritasveien 1, P.O.Box 300, 1322 Høvik, Norway. Tel: 47 67 57 99 00. www.dnvgl.com 2016/26 – DNV GL P. 3 / 18 ILPED201468EU-201626
3.2 Conformity assessment modules The designation of some conformity assessment modules have changed ; The old 97/23/EC The new 2014/68/EU A1 A2 B1 B (design type) B B (production type) C1 C2 For each category, the following modules are available; (modules for a higher category may be used for lower category equipment) 3.3 Category I Module A Category II Modules A2, D1, E1 Category III Modules B (design type) D, B (design type) F, B (production type) E, B (production type) C2, H Category IV Modules B (production type) D, B (production type) F, G, H1 Fluid Classification Change The new fluid classification is effected on 1st of June 2015: Chapter 3, Article 13, “Classification of pressure equipment.” An impact assessment by the European Commission showed that very few substances would actually change groups in the PED because of this change. The only significant change concerns the definition of flammable fluids, where the CLP has considered the PED definition. The below figure from the EC study illustrates the new classification. DNV GL Headquarters, Veritasveien 1, P.O.Box 300, 1322 Høvik, Norway. Tel: 47 67 57 99 00. www.dnvgl.com 2016/26 – DNV GL P. 4 / 18 ILPED201468EU-201626
3.4 Impact on Manufacturers Beside the changes in the Conformity Assessment Modules and fluid classification as described above, the harmonized standards will increase in importance as solutions to meet the ESR must be stated by the manufacturer if non-harmonized standards are used. This is expressed in the risk analysis requirements, which can now be found in Annex III for each module. As indicated under para 3.1 the user assembling pressure equipment into an integrated whole (pressure system) will be seen as ‘manufacturer’. The content of a Declaration of Conformity in Annex IV is also expressed more in detail. 3.5 Impact on Conformity Assessment Bodies The new PED lists Notified Bodies, Recognised Third Party Organisations and User Inspectorates as ‘Conformity Assessment Bodies’ (CAB). The horizontal requirements on Conformity Assessment Bodies will be implemented in the new PED. This includes stricter connection to accreditation and more focus on personnel competences at the Conformity Assessment. 4 Changes in detail For those interested in a more detailed analysis of the consequences of the introduction of the new PED, a transfer list in the new PED provides guidance on how the PED 97/23/EC is transferred to the new PED 2014/68/EU. In appendix I of this leaflet a table is included showing which new PED articles were covered by the PED 97/23/EC, including a specification of the changes. Practical changes to the PED are covered in this chapter. 4.1 Changes in fluid categorisation (art 13) as per 1st June 2015 Fluid groups 1 and 2 of PED 97/23/EC will remain. However the base for Group classification will be changed as the old Dangerous Substances directive – 67/548/EEC - is being replaced by the new CLP legislation. In practice these changes only concerns some toxic fluids and flammable liquids with a flash point between 21 and 23 centigrade. Working Group Pressure Guideline WPG B-01 is providing some guidance as well. 4.2 Module A1 into new PED Module A2 Monitoring of final assessment is to be performed at random intervals. 4.3 Module C1 into new PED Module C2 Same change as for Module A1 into A2. 4.4 Module B into new Module B (production type) Same approach as under the old PED. Requirements to CAB have some modifications. 4.5 Module B1 into new Module B (design type) Most remarkable is that B1 is integrated with module B and the new module B is split up in B (production type) and B (design type). For the B (design type) certificate, no prototype testing is DNV GL Headquarters, Veritasveien 1, P.O.Box 300, 1322 Høvik, Norway. Tel: 47 67 57 99 00. www.dnvgl.com 2016/26 – DNV GL P. 5 / 18 ILPED201468EU-201626
required, the validity is ten years and the technical file is to be stored another 10 years. Modules B and B1 are both Type Examinations. 4.6 Other Product modules and Quality System Modules The content of the product modules F and G and the quality modules D, D1, E, E1, H and H1 do not contain noticeable changes. 4.7 EU Declaration of Conformity The minimum content of the EU Declaration of Conformity (DoC) is described in more detail in Annex IV of the PED. It is expected that a number of manufacturers should review the content of their DoC and update accordingly, in order to comply with PED 2014/68/EU requirements. This can be combined with the introduction of the new PED Directive number on the DoC. 4.8 Nameplate with CE marking The text of the new PED requires the full postal address of the manufacturer to be available on the nameplate. Please note that our Notified body number has changed to 2388 (see chapter 8) this number should follow the CE marking. 5 5.1 Consequences of the new PED on new and running projects New projects New PED art 13 has been in effect as per 1st of June 2015. 5.1.1 Quality System Modules Applications will be assessed according PED 97/23/EC until July 18th 2016 and, when not finished on July 19th 2016, will be continued and certified according PED 2014/68/EU. All reporting and assessments performed under PED 97/23/EC remain valid under PED 2014/68/EU. Issuing a Declaration of Conformity or Certificate of Conformity according 2014/68/EU before 19 July 2016 is not allowed. Issued Certificates according PED 97/23/EC before 19 July 2016 remain valid after this date for PED 2014/68/EU. 5.1.2 Product Modules Applications will be assessed according PED 97/23/EC until 18 July 2016 and, when not finished on 19 July 2016, will be continued and certified according PED 2014/68/EU. All reporting and assessments performed under PED 97/23/EC remains valid under PED 2014/68/EU. Issuing Declaration of Conformity (manufacturer) and Certificate of Conformity (by CAB) according 2014/68/EU before 19 July 2016 is not allowed. Issued Certificates according PED 97/23/EC (before 19 July 2016) remain valid after this date. Meaning old and New PED modules can be combined after 19 July 2016, i.e. Module B (97/23/EC) with module D (2014/68/EU). 5.1.3 Particular Material Appraisals PMA’s issued before 19 July 2016, based on PED 97/23/EC remain valid under the new PED. 5.1.4 Welding approvals An approval on WPQR’s and WPQ’s issued before 19 July 2016, based on PED 97/23/EC remain valid under the new PED. DNV GL Headquarters, Veritasveien 1, P.O.Box 300, 1322 Høvik, Norway. Tel: 47 67 57 99 00. www.dnvgl.com 2016/26 – DNV GL P. 6 / 18 ILPED201468EU-201626
5.2 5.2.1 Ongoing projects on 1 June 2015 and on 19 July 2016 Quality System Modules Applications will be assessed according PED 97/23/EC until 18 July 2016 and will be continued and certified according PED 2014/68/EU. All reporting and assessments performed under PED 97/23/EC remain valid under PED 2014/68/EU. Issuing Declaration of Conformity (manufacturer) and Certificate of Conformity (by CAB) according 2014/68/EU before 19 July 2016 is not allowed. Issued Certificates according PED 97/23/EC before 19 July 2016 remain valid after this date. 5.2.2 Product Modules Applications will be assessed according PED 97/23/EC until 18 July 2016 and will be continued and certified according PED 2014/68/EU. All reporting and assessments performed under PED 97/23/EC remains valid under PED 2014/68/EU. Issuing Declaration of Conformity (manufacturer) and Certificate of Conformity (by CAB) according 2014/68/EU before 19 July 2016 is not allowed. Issued Certificates according PED 97/23/EC before 19 July 2016 remain valid after this date. A Manufacturer issuing a Declaration of Conformity after the transfer should make a reference to Art.48 resp. Art.41 if the DoC is based on Certificates issued before the transfer. 6 Appendix on changes New/Old PED Appendix 1 to this leaflet provides cross references between the new and the old PED. 7 Disclaimer This leaflet is assembled by DNV GL to provide guidance to clients on the introduction of the new PED 2014/68/EU. Interpretation of the Directive itself is not the responsibility of DNV GL. DNV GL does not accept any liability or responsibility for loss or damages resulting from any use of this document. DNV GL holds all rights to this information leaflet, including copyright. 8 Transition of Conformity Assessment Body number (2388) By transition of the Notification for PED from Det Norske Veritas B.V. – PCNL to DNV GL Business Assurance B.V. and the introduction of the new PED 2014/68/EU the Conformity Assessment Body number will change from 0427 into 2388 as per 19 July 2016. 9 Your contact in DNV GL For further information please contact the respective DNV GL PED Conformity Assessment Bodies (CAB) in UK (CAB 0097), Netherlands (CAB 2388), Italy (CAB 0496), Norway (CAB 0575) and Denmark (CAB 2099). DNV GL Headquarters, Veritasveien 1, P.O.Box 300, 1322 Høvik, Norway. Tel: 47 67 57 99 00. www.dnvgl.com 2016/26 – DNV GL P. 7 / 18 ILPED201468EU-201626
For any question or comment or if you do not want to receive information by DNV GL please revert to: DNV GL Business Assurance B.V. Conformity Body for Pressure Equipment Directive no. 2388 Zwolseweg 1 NL - 2994 LB Barendrecht E-mail: RotterdamPED@dnvgl.com Contact person: Chris van den Berg – Technical Manager DNV GL Headquarters, Veritasveien 1, P.O.Box 300, 1322 Høvik, Norway. Tel: 47 67 57 99 00. www.dnvgl.com 2016/26 – DNV GL P. 8 / 18 ILPED201468EU-201626
Appendix I Pressure Equipment Directive PED 2014/68/EU versus 97/23/EC 2014/68/EU of 15 May 2014 97/23/EC of 29 May 1997 Art Preamble Art Preamble Lid Lid Text THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Article 114 thereof, Having regard to the proposal from the European Commission, After transmission of the draft legislative act to the national parliaments, Having regard to the opinion of the European Economic and Social Committee ( 1 ), Acting in accordance with the ordinary legislative procedure ( 2 ), etc, etc Text THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty establishing the European Community, and in particular Article 100a thereof, Having regard to the proposals from the Commission (1), Having regard to the Opinion of the Economic and Social Committee (2), Acting in accordance with the procedure laid down in Article 189b of the Treaty (3), in the light of the joint text approved by the Conciliation Committee on 4 February 1997, etc, etc Modification A number of preambule items are modified. Take notice of them. CHAPTER 1 - GENERAL PROVISIONS 1 1 1 2 Scope This Directive shall not apply to: Etc, etc 1 1 1 3 Scope and definitions The following are excluded from the scope of this Directive: Etc, etc Equal Text modified. Equal consequences 2 1-14 15-32 1 2 For the purposes of this Directive: [definitions] 3 Definitions Definitions Making available on the market and putting into service 2 Market surveillance Nearly equal New Text modified. Equal consequences 4 Technical requirements 3 Technical requirements Text modified. Equal consequences 5 1 Free movement 4 1 Free movement Text modified. Equal consequences 5 2 Free movement 14 2 Free movement User inspectorate specified here as well. Equal consequences 5 3 Free movement 4 2 Free movement Text modified. Equal consequences DNV GL Headquarters, Veritasveien 1, P.O.Box 300, 1322 Høvik, Norway. Tel: 47 67 57 99 00. www.dnvgl.com 2016/26 – DNV GL P. 9 / 18 ILPED201468EU-201626
CHAPTER 2 - OBLIGATIONS OF ECONOMIC OPERATORS 6 7 8 9 10 Obligations of manufacturers Authorised representatives Obligations of importers Obligations of distributors Cases in which obligations of manufacturers apply to importers and distributors 11 Identification of economic operators New New New New New New 5 6 8 Presumption of conformity Committee on technical standards and regulations Safeguard clause Removed Removed Removed CHAPTER 3 - CONFORMITY AND CLASSIFICATION OF PRESSURE EQUIPMENT AND ASSEMBLIES 12 12 13 1 2 1 Presumption of conformity Presumption of conformity Classification of pressure equipment 13 1a Classification of pressure equipment 13 13 14 1b 2 15 New, noted. Rewritten Revised. Removed New. I.c.w. Regulation 1272/2008. Revised. Nearly equal Modified. Several Modules have new name and are modified:A2, B, C2. See Annex III for the modification of the Modules itself. Text modified. Equal consequences 11 9 9 4 1 2 European approval for materials Classification of pressure equipment Classification of pressure equipment Classification of pressure equipment Classification of pressure equipment Conformity assessment procedures 9 9 10 2 3 Classification of pressure equipment Classification of pressure equipment Conformity assessment 1 European approval for materials 11 1 European approval for materials 15 2 European approval for materials 11 2 European approval for materials Text modified. Equal consequences 15 3 European approval for materials 11 3 European approval for materials 15 15 4 5 European approval for materials European approval for materials 11 5 European approval for materials 15 6 European approval for materials 1 Notified bodies Recognized third-party organizations User inspectorates Text modified. Equal consequences New Text modified. Equal consequences New Removed Removed Text modified. Equal consequences 16 1 User inspectorates 12 13 14 DNV GL Headquarters, Veritasveien 1, P.O.Box 300, 1322 Høvik, Norway. Tel: 47 67 57 99 00. www.dnvgl.com 2016/26 – DNV GL P. 10 / 18 ILPED201468EU-201626
16 2-7 User inspectorates 14 3-8 User inspectorates Text modified. Equal consequences 14 9-10 User inspectorates Removed New New 15 1 CE marking Removed 17 EU Declaration of conformity 18 General principles of the CE marking CHAPTER 4 - NOTIFICATION OF CONFORMITY ASSESSMENT BODIES 19 1 Rules and conditions for affixing the CE marking 15 2 CE marking Text modified. Equal consequences 19 2 Rules and conditions for affixing the CE marking 15 3 CE marking Text modified. Equal consequences 15 4-5 CE marking 19 20 21 22 23 24 3-6 Rules and conditions for affixing the CE marking Notification Notifying authorities Requirements relating to notifying authorities Information obligation on notifying authorities Requirements relating to notified bodies and recognised thirdparty organisations Removed New New New New New New. Requirements to Notified Bodies are made more explicit. New New. Definition of Presumption of Conformity. New. Requirements to subcontract at Notified Bodies are made more explicit. New. Application requirements(Renewal application!). Accrediation or evidence compliance with accreditation standard is a prerequisite. New. Procedure. New, noted. New, noted. 25 26 Requirements relating to user inspectorates Presumption of conformity of conformity assessment bodies 27 Subsidiaries of and subcontracting by conformity assessment bodies 28 Application for notification 29 30 31 Notification procedure Identification numbers and lists of notified bodies Lists of recognised third-party organisations and user inspectorates 32 33 Changes to notifications Challenge of the competence of notified bodies, recognised third party organisations and user inspectorates DNV GL Headquarters, Veritasveien 1, P.O.Box 300, 1322 Høvik, Norway. Tel: 47 67 57 99 00. www.dnvgl.com 2016/26 – DNV GL P. 11 / 18 ILPED201468EU-201626 New, noted. New, noted.
34 Operational obligations of notified bodies, user inspectorates and recognised third party organisations New. Requirements to obligation at Notified Bodies are made more explicit. New. Requirements on Appeal at Notified Bodies are made more explicit. New. Some additional info to be provided to Notifying authorities. 35 Appeal against decisions of notified bodies, recognised third party organisations and user inspectorates 36 Information obligation on notified bodies, recognised third party organisations and user inspectorates 37 Exchange of experience New. For member states 38 Coordination of notified bodies, recognised third-party organisations and user inspectorates New. For Commission and Member states 16 17 18 Unduly affixed CE marking Member States Decisions entailing refusal or restriction Removed Removed Removed CHAPTER 5 - UNION MARKET SURVEILLANCE, CONTROL OF PRESSURE EQUIPMENT AND ASSEMBLIES ENTERING THE UNION MARKET, AND UNION SAFEGUARD PROCEDURE 39 Union market surveillance and control of pressure equipment and assemblies entering the Union market New. For Commission and Member states New. For Member states 40 Procedure for dealing with pressure equipment or assemblies presenting a risk at national level 41 Union safeguard procedure New. For Commission and Member states 42 Compliant pressure equipment or assemblies which present a risk New. For Commission and Member states 43 Formal non-compliance New. For Commission and Member states CHAPTER 6 - COMMITTEE PROCEDURE AND DELEGATED ACTS 44 1 Committee procedure 44 2-5 Committee procedure 44 5,1stp Committee procedure 7 2 Committee on Pressure Equipment DNV GL Headquarters, Veritasveien 1, P.O.Box 300, 1322 Høvik, Norway. Tel: 47 67 57 99 00. www.dnvgl.com 2016/26 – DNV GL P. 12 / 18 ILPED201468EU-201626 Text modified. Equal consequences New. For Commission New. For Commission
44 5,2ndp Committee procedure 7 4 Committee on Pressure Equipment 45 Delegated power 7 1 Committee on Pressure Equipment 7 3 Committee on Pressure Equipment 46 Exercise of the delegation 1-2 3 Repeal Transposition and transitional provisions Transposition and transitional provisions Text modified. Equal consequences Text modified. Equal consequences Removed New. For Commission CHAPTER 7 - TRANSITIONAL AND FINAL PROVISIONS 47 48 48 49 Penalties 1 2-3 Transitional provisions Transitional provisions Transposition 50 Repeal 51 Entry into force and application 52 Addressees ANNEX I - ESSENTIAL SAFETY REQUIREMENTS 0 1 2 2.1 19 20 20 21 Addressees of the Directive New Removed Removed Revised, noted. New, noted New. - Article 13 to be implemented 28 February 2015 in National Legislation by Member states, entrance date 1 June 2015. - New PED 2014/68/EU to be implemented July 18th 2016 in National Legislation by Member States, entrance date July 19th 2016 . New. Confirmation of repeals old PED parts. New. Entrance date new PED Directive (17 July 2014). Noted Addressed to member states as PED to be implemented in National Legislations. ANNEX I - ESSENTIAL SAFETY REQUIREMENTS PRELIMINARY OBSERVATIONS GENERAL DESIGN General DNV GL Headquarters, Veritasveien 1, P.O.Box 300, 1322 Høvik, Norway. Tel: 47 67 57 99 00. www.dnvgl.com 2016/26 – DNV GL P. 13 / 18 ILPED201468EU-201626 No relevant changes No relevant changes No relevant changes
2.2 2.3 2.4 2.5 2.6 2.7 2.8 2.9 2.10 Design for adequate strength Provisions to ensure safe handling and operation Means of examination Means of draining and venting Corrosion or other chemical attack Wear Assemblies Provisions for filling and discharge Protection against exceeding the allowable limits of pressure equipment Safety accessories External fire 3 MANUFACTURING 3.1 Manufacturing procedures 3.2 Final assessment 3.3 Marking and labelling 3.4 Operating instructions 4 MATERIALS 4.1 Materials for pressurised parts 4.2 The pressure equipment manufacturer 4.3 Materials used SPECIFIC PRESSURE EQUIPMENT REQUIREMENTS 5 FIRED OR OTHERWISE HEATED PRESSURE EQUIPMENT WITH A RISK OF OVERHEATING AS REFERRED TO IN ARTICLE 4(1) 6 PIPING AS REFERRED TO IN ARTICLE 4(1) 7 SPECIFIC QUANTITATIVE REQUIREMENTS FOR CERTAIN PRESSURE EQUIPMENT 7.1 Allowable stresses 7.2 Joint coefficients 7.3 Pressure limiting devices, particularly for pressure vessels 7.4 Hydrostatic test pressure 7.5 Material characteristics ANNEX II - CONFORMITY ASSESSMENT TABLES No relevant changes No relevant changes No relevant changes No relevant changes No relevant changes No relevant changes No relevant changes No relevant changes No relevant changes 2.11 2.12 1 Modules 2 Safety Accessories 3 Pressure Accessories 4 Tables (9x) ANNEX III - CONFORMITY ASSESSMENT PROCEDURES Introductory wording No relevant changes No relevant changes No relevant changes No relevant changes No relevant changes No relevant changes No relevant changes No relevant changes No relevant changes No relevant changes No relevant changes No relevant changes No relevant changes No relevant changes No relevant changes No relevant changes ANNEX II - CONFORMITY ASSESSMENT TABLES No relevant changes No relevant changes No relevant changes No relevant changes ANNEX III - CONFORMITY ASSESSMENT PROCEDURES Introductory wording DNV GL Headquarters, Veritasveien 1, P.O.Box 300, 1322 Høvik, Norway. Tel: 47 67 57 99 00. www.dnvgl.com 2016/26 – DNV GL P. 14 / 18 ILPED201468EU-201626 No relevant changes
1 1 2 3 4 5 2 1 2 3 4 5 6 3 3.1 MODULE A: (INTERNAL PRODUCTION CONTROL) Procedure Technical documentation Manufacturing CE marking and EU declaration of conformity Authorised representative MODULE A2: INTERNAL PRODUCTION CONTROL PLUS SUPERVISED PRESSURE EQUIPMENT CHECKS AT RANDOM INTERVALS Procedure Technical documentation Manufacturing Final assessment and pressure equipment checks CE marking and EU declaration of conformity Authorised representative MODULE B: EU-TYPE EXAMINATION EU-Type examination – Production Type 1 2 3 4 5 6 7 8 9 Explanation Procedure Manufacturer Notified Body Notified Body Evaluation Report EU Type-Examination Certificate Remain Type-Examination valid Inform Notifying Authority Archiving Application and Certification documents by Notified Body 10 Authorised representative EU-Type examination – Design Type 3.2 1 2 3 4 5 6 7 8 MODULE A: (INTERNAL PRODUCTION CONTROL) No relevant changes No relevant changes No relevant changes No relevant changes No relevant changes MODULE A1: internal manufacturing checks with monitoring of the final assessment) Revised Revised Revised Revised Revised Revised MODULE B: EU-TYPE EXAMINATION Revised Revised Revised Revised Revised Revised Revised Revised Revised Revised MODULE B1: EC design-examination Explanation Procedure Manufacturer Notified Body Notified Body Evaluation Report EU Type-Examination Certificate - 10 years Remain Type-Examination valid Inform Notifying Authority DNV GL Headquarters, Veritasveien 1, P.O.Box 300, 1322 Høvik, Norway. Tel: 47 67 57 99 00. www.dnvgl.com 2016/26 – DNV GL P. 15 / 18 ILPED201468EU-201626 Revised Revised Revised Revised Revised Revised Revised Revised
9 Archiving Application and Certification documents by Notified Body 10 Authorised representative MODULE C2: CONFORMITY TO TYPE BASED ON INTERNAL PRODUCTION CONTROL PLUS SUPERVISED PRESSURE EQUIPMENT CHECKS AT RANDOM INTERVALS 4 1 2 3 4 5 5 1 2 3 4 5 6 7 8 6 1 2 3 4 5 6 7 8 9 10 7 1 2 3 4 5 Procedure Manufacturing Final assessment and pressure equipment checks CE marking and EU declaration of conformity Authorised representative MODULE D: CONFORMITY TO TYPE BASED ON QUALITY ASSURANCE OF THE PRODUCTION PROCESS Procedure Manufacturing Quality system Surveillance under the responsibility of the notified body CE marking and EU declaration of conformity Archiving by manufacturer Inform Notifying Authority Authorised representative MODULE D1: QUALITY ASSURANCE OF THE PRODUCTION PROCESS Procedure Technical documentation Archiving by manufacturer Manufacturing Quality system Surveillance under the responsibility of the notified body CE marking and EU declaration of conformity Archiving by manufacturer Inform Notifying Authority Authorised representative MODULE E: CONFORMITY TO TYPE BASED ON PRESSURE EQUIPMENT QUALITY ASSURANCE Revised Revised MODULE C1: conformity to type) Revised Revised Revised Revised Revised MODULE D: production quality assurance No relevant changes No relevant changes No relevant changes No relevant changes No relevant changes No relevant changes Revised No relevant changes MODULE D1: production quality assurance No relevant changes No relevant changes No relevant changes No relevant changes No relevant changes No relevant changes No relevant changes No relevant changes Revised No relevant changes MODULE E: product quality assurance Procedure Manufacturing Quali
The Pressure Equipment Directive (PED 97/23/EC) has been in place since the 29th May 2002. It will be replaced by PED 2014/68/EU as per 19 July 2016. Two main factors have enforced the new PED The basis for the determination of fluid group (1 or 2) in PED Article 9 (i.e. Directive
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