Directive 97/23/EC on Pressure Equipment (PED) --- Baltic Pressure Equipment Workshop Riga, 27-28 November 2003 1
Fundamentals Roots at the times of the Industrial revolution Technically one of most complex areas Involves severe hazards Highly regulated Rather heterogenious legislation Economically substantial (approx( 90 bio ) Need to have a harmonized regulatory framework 2
New Approach Technical harmonisation to support the Common Market 19 sectors to date Define Essential Safety Requirements (ESRs) Establish hazard categories List Conformity Assessment Procedures Self certification / Notified Bodies Assessment Affix CE-mark Free movement within EEA Harmonised Standards to provide presumtion of conformity 3
Pressure Equipment Directive Ensures free movement of goods (PE), for products which fall within its scope, which meet the ESR, having completed Conformity Assessment or are Art 3.3 (SEP) equipment. PED harmonises the previously fragmented European PE market 4
Scope Pressure vessels Piping Pressure accessories Safety Accessories and Assemblies Limited to: - pressure hazard - pressure greater than 0.5 bar - equipment placed on the market OR put into service - assemblies placed on the market AND put into service 5
Assemblies Several pieces of pressure equipment, provided 1. the result is integrated 2. the result is functional 3. they are a whole 4. they are assembled by one manufacturer NOTE : a- the assembly can be built in a workshop or on-site b- there is no upper limit to an assembly c- an assembly can be composed of smaller assemblies and items of pressure equipment d- when not placed on the market, assemblies are not covered 6
Assemblies: Examples Pressure cookers Fire extinguisher Bottles for breathing apparatus Autoclaves Valve systems Pressure regulators Pressure safety devices etc. Gas storage tanks Boilers Steam generators Destillation columns Heat exchangers Refrigeration systems Air conditioning systems Turn-key plants etc. 7
Essential Safety Requirements (ESRs) -General obligations for manufacturer - e.g. to carry out hazard analysis incl. reasonably foreseeable misuse - to establish technical documentation file - Design and calculation - Manufacturing - manufacturers capabilities - manufacturing/joining procedures - Materials - Specific requirements - for fired or otherwise heated pressure equipment - for piping - Specific quantitative requirements (general rule) 8
Conformity Asessement Category I : Manufacturer Self Assessment Category II, III, IV : Notified Body Assessment Categories established depending on Hazard Level 13 different CA Modules available Simplified assessment when using Harmonized Standards Specific provisions for the application of a QMS 9
Determination of applicable category Classification Group I fluid Group II fluid vessels gaseous Table 1 Table 2 liquid Table 3 Table 4 piping gaseous Table 6 Table 7 liquid Table 8 Table 9 Pressure accessories Safety accessories volume DN general specific according to table 1-41 according to table 6-96 Category IV Category of respective equipment Assemblies According to highest element (except safety acc.) 10
Conformity assessment tables (A) Vessels for dangerous gases Vessels for non-dangerous liquids (Table 1) (Table 4) 11
Conformity assessment tables (B) Piping for dangerous gases Piping for non-dangerous liquids Table 6 Table 9 12
Conformity assessment for assemblies Global procedure - assessment of each item making up the assembly (when not CE-marked) - proper integration of these items - essential requirements 2.3, 2.8 and 2.9 of Annex I - protection against exceeding permissible operating limits - essential requirements 2.10 and 3.2.3 of Annex I 13
Harmonized Standards Developed following Mandate /071 from the EC to CEN Designated by CEN as Candidate for Harmonization Substantiating/providing technical solutions to the Essential Safety Requirements of the PED Providing a means of fulfilling at least one ESR Containing an Annex ZA to provide a reference between the pertaining section of the EN and the ESRs of the PED Giving Presumption of Conformity to the adressed ESRs of the PED when published in the OJEU 14
Sound engineering practice For Article 3.3 (SEP) products (i.e. below category I), the manufacturer must ensure the safe use of the equipment : - design and manufacture must take into account all relevant factors, influencing safety during intended lifetime (safe to be used) - adequate instructions for use - identification of manufacturer or authorized representative No Declaration of Conformity, Compliance Statement recommended 15
Formal/documentation requirements Always Perform hazard analysis Compile technical file Perform conformity assessment Obtain material certificate Produce instructions for use For higher categories Involve Notified Body Have welding methods/ welders approved by TPO Have NDT personnel approved by TPO Certificate of specific product control for materials 16
Legal aspects 1. Transposition into national Law by MSs 2. Notification of NBs and TPOs by MSs 3. Publication of Harmonized Standards in the Official Journal of the European Community 4. Obligation to MSs not to prohibit, restrict or impede placing on the market of complying PE 5. Obligation to manufacturer, not to place non-compliant compliant, unsafe or unduly CE-marked products on the market 6. Safeguard clause procedure against unsafe products 7. Formal objection of non-complying Harmonized Standards 8. Obligation to MSs to do Market Surveillance 17
Potential pitfalls Inappropriate expectation of authorization of deviations e.g. for economic reasons History oriented rules for in-service inspection periods Following short-cutting advice Abreviated hazard analysis Sole reliance on previous procedures ==> maintain professional proportionality 18
Hierarchy of Terms Defined in PED Example Materials No Steel plates, seamless tubes Components of Pressure Equipment Pressure Equipment No Yes Welded tubes, dished ends LPG tank, safety valve Assemblies Yes Boiler, chemical plant PED-ESRs applicable Yes Yes Yes Only if assembled by manufacturer CEmarked No No Yes Only if assembled by manufacturer NB: The table should illustrate the general situation and therefore provides a simplified picture without any details and exceptions. 19
PED: Hot Topics Interface of placing on the market and operation European versus national responsibility New concepts of New Approach legislation Integration of SPVD in PED User Inspectorates : future scope & tasks Promotion of European Standardisation Trade aspects of pressure equipment European Approvals for Materials 20
European Approval for Materials First Set of EAMs on Nickel 201 published in OJ 2003/C 233/10, see reference list at http://europa.eu.int/comm/enterprise/pressure_equipment/index.htm Guiding Principles and standard form downloadable at http://ped.eurodyn.com/materials/materials.html ped.eurodyn.com/materials/materials.html Orgalime support facilitating drafts of EAMs (EU contract): http://www.orgalime.org/positions/eam.htm 21
Further information Commission web-site : http://ped.eurodyn.com ped.eurodyn.com PED WGP Guidelines National Authorities Euro Info Centers Industry Associations Notified Bodies Directive text itself 22