Summary

The Directive 97/23/EC issued by the European Parliament and the Council

The Directive 97/23/EC, adopted by the European Parliament and the Council on 29 May 1997 (>> consolidated text in English), known with the acronym PED (Pressure Equipment Directive), was published on the European Official Journal L 181, 9.7.1997, p. 1 and has come into force on 29 November 1999.

The transitory period, during which the manufacturers had a choice between applying the pressure equipment directive or continuing with the application of the existing national legislation, was concluded on 29 May 2002. From 30 May 2002 the pressure equipment directive is obligatory throughout the entire EU.

Current legislation

The current status of the legislation is provided by the web site EUR-Lex (>>) and by the web site Pressure equipment and gas appliances of the European Commission.

Amendments and errata corrige

1. M1, 32003R1882: Regulation (EC) No 1882/2003 of the European Parliament and of the  Council of 29 September 2003 (OJ L 284, p.1-53, 31.10.2033) (read >>): modified Articles 7.2 e 7.3.
2. M2, 32012R1025: Regulation (CE) n. 1025/2012 of the European Parliament and the Council of 25 October 2012 (OJ L 316, p.12, 14.11.2012) (read >>): abolition Article 6 from 01/01/2013.

1. 31997L00223R(01): Corrigendum C1 to Directive 97/23/EC, OJ L 265, 27.9.1997, p.110 (97/23/CE) (read >>).
2. 31997L00223R(02): Corrigendum C2 to Directive 97/23/EC, OJ L 250, 23.9.1999, p. 14-14 (web page >>).
3. 31997L00223R(02): Corrigendum C3 to Directive 97/23/EC (this corrigendum does not concern the English version).
4. 31997L00223R(04): Corrigendum C4 to Directive 97/23/EC, OJ L 93, 7.4.2011, p. 38 (97/23/EC) (read >>).

Activities in progress

1. Study (conducted in 2012-2013) of the changes required to Article 9 of the PED, to align it to the Classification, Labelling and Packaging (CLP) Regulation (>> Regulation EC No 1272/2008 of 16.12.2008) regarding the Dangerous Substances (>> read the Study Report). This Regulation, over a transitional period that will end on 31 May 2015, will replace the Dangerous Substances Directive or DSD No. 67/548/EEC (>> read text of the Directive 67/548/EEC of 27.6.1967).
2. Legislative proposal (>> read the proposal) to align the PED to the New Legislative Framework (NLF) established with the Decision No. 768/2008 (>> read the text of the Decision No. 768/2008 of 9.7.2008) and to the CLP Regulation.

To this purpose, the page Enterprise and Industry of the European Commission web site highlights the article “Fairer, safer, simpler: New rules for pressure equipment” of the Enterprise & Industry Magazine (>> read the article) of 4/10/2013.

Directive evaluation

An independent evaluation of the Pressure Equipment Directive was performed in 2011-2012. As described in the page “Pressure Equipment Directive (PED): overview” (>>), the purpose of the evaluation has been to assess how, and to what extent, the Directive has met its objective of guaranteeing free circulation of stationary pressure equipment within the EU while ensuring a high degree of safety.

The outcomes of this evaluation are provided in two reports, both available in the web page aforementioned: a) Evaluation of the Pressure Equipment Directive: Final Report (>>), October 2012; b) Evaluation of the Pressure Equipment Directive: Executive Summary (>>), October 2012.

Implementation in Italy

The Directive 97/23/CE has been acknoweledged and implented in Italy with the Legislative Decree no. 93 of 25 February 2000 (>> read text of D.Lgs. no. 93).

Later on the Italian Government issued Legislative Decree no. 23 of 2 February 2002, “Regarding the accomplishment of the Directives 1999/36/EC, 2001/2/EC and the Decision 2001/107/EC regrading the transportable pressure equipment“ (>> read). Note: presently this Decree is almost entirely repealed (>> text).

Operation and service of pressure equipment being not regulated by the PED, since the European Union directive refer only to the product, is delegated to the national regulation.

On this respect, the Ministry of Production Activities issued the Decree no. 329 of 1 December 2004, “Regulation providing norms to put into service and using pressure equipment and the assemblies defined by the Article 19 of the Legislative Decreeno. 93 of  25 February 2000” (>> read Decree 1 December 2004, no. 329).

The Ministry of Production Activities on 23 May 2005 issued the Ministerial Memorandum “Check of putting into service and following checks, as per the Ministerial Decree no. 329 of 1 December 2004“ (>> text).

The Ministry of Production Activities on 2 March 2005 issued the Ministerial Memorandum no. 2117, “Technical reference norm for pressure equipment and the assemblies according to the Directive 97/23/EEC and on the simple pressure equipment as per the Directives 87/404/EEC and 90/488/EEC.” (>> text).

Harmonised standards

On a periodic basis, the European Commission updates the list of the European standards harmonised with the PED, whose application provides presumption of conformity to the Directive.

The last available update (from the page Enterprise and Industry of the European Commisison web site >>) was published on the European Union Official Journal 24.01.2014 (OJ 2014/C 22/01) (>> read the updated list of the harmonised standards). [Note: the previous list was published on 4.5.2013 (OJ 2013/C 128/1) (>> read the previous list of the harmonised standards)].

WGP guidelines

The working group “Pressure” (acronym WGP) appointed by the European Commission developed and continues to develop a set of guidelines that, even though are not legally binding, represent, however, a reference for ensuring a consistent application of the directive.

They are subdivided into ten sections related to different subjects; namely:

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. Interpretazione dei requisiti essenziali di sicurezza attinenti ai materiali
8. Interpretation of the essential requirements on materials
9. Miscellaneous
10. General / Horizontal issues

The current updated version of the guidelines is the 14^th which includes all the guidelines issued by the WGP till the meeting of 7/3/2013.

Information on the guidelines are available in the proper page of the European Commission web site (in English, French and German only): “Pressure Equipment Directive (PED): guidelines”. This page is linked to the complete set (>>) of the 14^th version (255 pages).

Orgalime fiche

Orgalime (European Engineering Industries Association) issued  some PED application guidelines that can be downloaded upon free registration at the page Orgalime Guides (>>):

1. Orgalime Guide Assembly under PED;
2. Pressure Equipment Directive – Orgalime Guide, May 1999, updated April 2008 (available also at the web site www.anima.it).

Orgalime issued the following PED fiches : 3/4, 4/1, 5/2, 6/1, 15/1, 19/1, 22/1, 30/1, 31/1, 37/1, 46/1, 52/3, 60/2, 64/2, 75/3, 76/1, 80/2, 83/3, 87/2, 146/0, 149/0, 154/2, 155/1, 156/2, 158/2, 159/1, 173/1, 175/1, 177/1, 179/1, 182/1, 193/1; where, the first digit indicates the fiche serial number and the second digit indicates the current version. In red are shown the fiches that are still valid and are included in the Orgalime Guide issued on April 2008.

Italian technical guides

The market surveillance in Italy is upon the Ministry of Economic Development (MiSE) which, as technical-scientific authority, makes use of INAIL in order to perform the evaluation of the conformity to the safety and health requirements of the products used by the workers. The law 30 July 2010, no. 122, assigned to INAIL the responsibility in the past attributed to ISPESL (Advanced institute for prevention and safety on the work). ISPESL, besides operating as Notified Body for the PED, perform the certification and the acknowledgment of the laboratories and certification bodies provided for by the community directives.

ISPESL in 2003 issued the following guide on PED:  “Practical guide to the PED Directive on pressure systems” (>> Part 1; >> Part 2). [Note: available in Italian only].

Since the present Italian legislation assigns to them the function to perform the first check before putting in service a system, ISPESL issued on this respect the following technical documents:

• “Examples of piping systems and pressure equipment subject to the art. 16 of D.M. 329/04 related to operating plants”, 20/04/2007 (>> text) [Note: available in Italian only];
• “The visual examination of pressure equipment, for the purpose of the construction and operation checks”, ISPESL, Department of Homologation and Certification, Department Safety Technologies, January 2006 (>> text) [Note: available in Italian only];
• Memorandum n. 14/05: “Application of D.M. 329/04 for the accomplishment of art. 19 del D. Lgs. 93/2000 – Clarifications and specifications regarding the Repair”, 06/12/2005 (>> text) [Note: available in Italian only];
• ISPESL, Brescia territorial Department, Natale Palumbo, “Competences and duties of the Notified Bodies, of the inspectors and those resulting for the users, D.M. 1 December 2004, n. 329“ (>> text) [Note: available in Italian only].

The Conference of Regions issued the following document:

• “Operating procedure for the application of the decree 1 December 2004 no. 329, regulation providing norms for putting into service and using the pressure equipment and the assemblies covered by Article 19 of the legislative decree 25 February 2000 no. 93” (>> text) [Note: available in Italian only].

Many technical guides were, in addition, developed and issued by companies and bodies involved on pressure equipment.

Among them, for information only and with no intention of completeness, the following ones are mentioned:

• Baglioni, Guide to D.M. 329/2004 (>>)
• Gruppo Fiorini, Guide to P.E.D. (>>);
• Tenaris, information booklet on PED (>>);
• Fisher, Bullettin 71:009 (PED), Guide to the classification of regulators based on the Pressure Equipment Directive (PED) (>>);
• Italcert, Pressure equipment – PED (>>);
• Health Project, Guidelines for the evaluation of the conformity of pressure equipment (>>);
• TÜV Italy, Inspections and certifications according to PED (>>);
• G. Fiori International Srl, PED Directive (>>);
• Bureau Veritas, About service inspections (>>);
• Gi.efFFE.M., D.M. 1 December 2004, no. 329 (>>).

International technical guides

A number of international bodies working on the certification of pressure equipment issued technical guides for the PED implementation.

Among them, for information only and with no intention of completeness, are mentioned the following ones:

• DTI, Product Standards, Pressure Equipment, Guidance Notes on the UK Regulations, April 2005, URN 05/1074 (>> text).
• Blackmonk Engineering Ltd – Simon Learman, A Process Engineer’s Guide to the Pressure Equipment Directive, 2 April 2009 (>> text).
• HSB Global Standards – PED Selection Guide – 4 Easy Steps – 20010302 (>> text).
• HSB Global Standards – Quick Reference Guide - PED Selection Guide (>> text).
• Force Certification, PED – Guide (>> text).
• Fisher/Emerson, Bulletin MCK 2132 (PED), Pressure Equipment Directive (PED), Classification Guide for LP Gas Products, September 2005 (>> text).
• USA, NIST GCR 04-870, A Guide to the EU Pressure Equipment Directive, October 2003 (>> text).
• Cyprus Republic, Guide to the implementation of Directive 97/23/EC on Pressure Equipment, May 2004 (>> text).
• ECE Global, LLC – Particular Material Appraisals (>> text).
• United Kingdom, HSE-Health and Safety Executive, The Law on Pressure Equipment Directive (Directive 97/23/EC) ((PED) (>> text).
• Meyer International Conformity Assessment Services Co. Ltd., Turkey, A practical guide to 97/23/EC PED: EU Pressure Equipment Directive (>> text).

Comparative studies with ASME BPVC

The American Society of Mechanical Engineers (ASME) published two guides for the ASME stamp-holders in order to explain how fulfilling the PED requirements when the ASME Boiler and Pressure Vessel Code (BPVC) is used for construction:

• ASME Section I PED Guide, Supplement to Guide for ASME Stamp Holders Use of ASME Section I to Meet the EC Pressure Equipment Directive (97/23/EC), ASME doc. STP/PT-002, 2005 (can be purchased on ASME web site: >> text);
• Comparison of Pressure Vessel Codes ASME Section VIII and EN 13445 – Technical, Commercial, and Usage Comparison – Design fatigue Life Comparison, ASME doc. STP-PT-007, 2006 (the pdf can be downloaded form the ASME web site: >> text).

The ASME STP-PT-007 is essentially aimed at replying to the study committed by the European Commission, prepared by TÜV Austria and CEC (Italy) and issued in July 2004:

• Summary “Comparative Study on Pressure Equipment Standards”, July 2004. The pdf can be downloaded from the page “Enterprise and Industry - Comparative Study” of the European Commision web site (in English only): >> Comparative Study Summary.

In 2008, the working group PED/SPV of the “Conformity Assessment Body Forum“ (CABF, see page Conformity assessment bodies in the European Commission web site) published in the proceedings of the 32^nd meeting CIRCA held in Brussels on 4/3/2008 an informal technical report regarding the ASME STP/PT-002 document:

• Review of Supplement to Guide for ASME Stamp Holders in the use of ASME Section I to meet the EC Pressure Equipment Directive 97/23/EC.

In 2011 and 2013 the ASME Italy Section on this subject organized two international Conferences, where the main sectorial experts described how fulfilling the PED requirements by making use of the ASME BPVC:

• 2011 Conference on PED Requirements and ASME Code, 20-21 October 2011, Genoa, Italy (>> web site);
• 2013 Conference on PED Requirements and ASME Code, 14-15 November 2013, Genoa, Italy (>> web site).

Attention to this argument was given also by the Convention SAFAP 2010, Sicurezza ed affidabilità delle attrezzature a pressione, Venice, 13-14 May 2010, whose proceedings are available in the ISPESL web site (>>).

Main technical aspects

Background

Based on Article 1, clause 1, the directive 97/23/EC applies to pressure equipment or assemblies with a maximum allowable pressure (PS) greater than 0,5 bar.

“Pressure equipment” means vessels, piping, safety accessories and pressure accessories, in addition all the elements attached to pressurized parts, such as flanges, nozzles, couplings, supports, lifting lugs, etc.

Based on Article 9, pressure equipment are classified into four categories (three for piping) depending upon the pressure value, the size (internal volume or nominal diameter for piping only) and the fluid content (liquid or gas, dangerous or not dangerous). The level of hazard is increasing with ascending category.

A different module of conformity assessment applies to each category from I to IV. All equipment or assemblies classified into category I through IV shall have affixed the CE mark.

Any equipment that, even though subject to a pressure value greater than 0,5 bar, have size and fluid content such that do not enter into category I, shall not have affixed the CE mark and are not subject to any specific module of conformity assessment (Art. 3.3).

Materials

1. Materials following a harmonised standard;
2. Materials covered by an European approval for materials (EAM);
3. Materials subject to a particular appraisal (PMA).

For the first family, reference is made to the harmonised standards whose list is published in the European Union Official Journal.

To the second family belong the materials ruled by the Articles 1.2.9 (Scope and definitions) and 11 (European approval for materials). The document PE-01-01 (version approved by the WGP on 17 March 2004), Guiding principles for the contents of EAM drafts (>>) provides the requirements of an EAM. This subject is dealt with by some guidelines: in Heading 7 (>>) and Heading 9 (>>). The above recalled web page provide also with the links to the list of EAMs currently submitted (>>) and List of published EAM (>>).

For the material subject to a particular appraisal (PMA), the above mentioned web page provides with the link to the document PE 03-28 (version approved by the WGP on 21 November 2006), Guiding principles for the content of PMA (>>), which describes the requirements for the PMAs.

On this subject interesting is the following web page (in Italian only): materials in PED directive (http://www.claudiotomasoni.it/wordpress/?p=117).

The Technical File

One the most relevant aspects of the directive 97/23/EC is the preparation of the Technical File cared by the manufacturer. Each product put on the marked is to be provided with a Technical File kept by the manufacturer (or his authorized representative established within the Community as per the directive statement) at the disposal of the Safety Authorities for a period of ten years after the last of the pressure equipment has been manufactured

1. DESIGN DATA AND EQUIPMENT DESCRIPTION
2. REFERENCE DOCUMENTS
3. HAZARD ANALYSIS
4. CHECK OF THE ESSENTIAL SAFETY REQUIREMENTS
5. DESIGN REPORT AND DRAWINGS
6. USE AND MAINTENANCE MANUAL FOR THE USER
7. MATERIALS
8. MANUFACTURING PROCEDURE
9. PERMANENT JOINTS
10. QUALITY CONTROL PLAN
11. NON-DESTRUCTIVE EXAMINATIONS
12. FINAL INSPECTION REPORT
13. MANUFACTURER'S DECLARATION OF CONFORMITY

The design report, the drawings (assembly and detail), the use and maintenance manual, the applied procedures, the quality control plan, etc., will in general be separate documents referred by and attached to the Technical File.

Hazard analysis

The hazard analysis is a fundamental part of the Technical documentation, being a clear requirements of the directive 97/23/EC. The list of the standards harmonized with the PED does not include any standard dealing with the hazard analysis as, it occurs for the Machine Directive (2006/42/EC). Performing the hazard analysis is one of the essential safety requirements (ESR) of the PED, as it is mentioned by the clause 1.1 of the Annex I.

Since there is no harmonised standard for the PED hazard analysis, there is no definitive reference for it- A useful reference is, anyhow, the standard EN 12100:2010 harmonised with the Machine Directive, which provides the necessary conceptual tools.

The hazard analysis for pressure equipment is in general based on aWhat-if approach (adopted for situations where the dangerous events tree is relatively simple). The starting point is a list of possible failures and the dangerous events that they can raise. For each fault the severity of the caused damage is evaluated and the frequency of the fault and the related hazard. Based on them the level of the risk, as product of severity times frequency of the hazard, is then evaluated. If the risk level index is not acceptable, the measures taken to remove or reduce the related hazard are described. When not possible taking any measures to remove or reducing the hazard, suitable information to the users are provided (information on the residual hazards).

The safety essential requirements

The identification of the essential safety requirements (acronym ESR), which, under the public interest protection standpoint (health and safety of the users, protection of property and environment), have to be fulfilled by the product, is the fundamental new element of the New Approach Directives, including PED. These requirements apply to homogenous products for which is possible identifying a horizontal risk, i.e. common hazards. The essential safety requirements are usually listed in the Annex I of each New Approach Directive, as it is for the PED, too.

The ESR are generally of qualitative type, since the New Approach Directives are not aimed at providing a technical specification, such as a construction technical norm, but leave to the manufacturer to select the preferred solution to fulfill them. Usually, they are in the form of the general principles that have to be fulfilled by the product in order to meet the minimum safety level required to allow the free movement within the European market. They are written in order to allow the conformity assessment even in case there is no applicable harmonized standard or the manufacturer chooses not using any harmonized standard.

1. The allowable stress calculation;
2. The joint coefficients;
3. The pressure peak temporarily admitted when using pressure limiting devices;
4. The hydrostatic test pressure; and,
5. The material characteristics, in terms of elongation after rupture and the bending rupture energy.

The analysis of the fulfilment of the essential safety requirements is necessarily coordinated with the hazard analysis which, through the identification of the product limits, the possible failures and the consequent hazards, allows identifying what essential safety requirements apply to the product. The process is of iterative type, since the detail analysis of the essential safety requirements has a potential to highlight hazards initially not considered and, therefore, the need of removing or reducing them. The essential safety requirements shall be applied depending upon the hazards pertaining to a given product.

Web sites

European Commission

• European Commission, Enterprise and Industry, page “Pressure equipment and gas appliances”: http://ec.europa.eu/enterprise/sectors/pressure-and-gas/index_it.htm
• Pressure equipment sector: http://ec.europa.eu/enterprise/sectors/pressure-and-gas/pressure-equipment/index_en.htm
• Magazine Enterprise & Industry: http://ec.europa.eu/enterprise/magazine/index_it.htm
• European standards: http://ec.europa.eu/enterprise/policies/european-standards/index_it.htm
• Harmonised standards: http://ec.europa.eu/enterprise/policies/european-standards/harmonised-standards/index_en.htm
• European Union: http://ec.europa.eu/enterprise/sectors/pressure-and-gas/documents/ped/
• CIRCABC (Communication and Information Resource Centre for Administrations, Business and Citizens): PED – Workshops in Pressure Equipment

Italian Public Authorities

• Ministry of Economic Development (MSE): http://www.sviluppoeconomico.gov.it/

• Ministry of Health: http://www.salute.gov.it/
• INAIL (National Institute for Insurance against Work Accidents): http://www.inail.it/internet_web/appmanager/internet/home
• Former-ISPESL (Advanced Institute for Prevention and Safety on Work): http://www.ispesl.it/
• ACCREDIA – The Accreditation Italian Body: http://www.accredia.it/

Standardization bodies

• CEN (Comité Européen de Normalisation): http://www.cen.eu/cen/pages/default.aspx; >> page on PED
• UNI (Ente Nazionale Italiano di Unificazione): http://www.uni.com/
• DIN (Deutsches Institut für Normung): http://www.din.de/cmd?level=tpl-home&contextid=din
• BSI (British Standards Institute): http://www.bsigroup.com/en-GB/
• AFNOR (Association Française de Normalisation): http://www.afnor.org/

Italian manufacturers associations

• ANIMA (Federation of National Associations of Mechanical Industry): http://www.anima.it/; >> page on PED
• AICARR (Italian Association  Air Conditioning, Heating and Cooling): www.aicarr.org; >> page on PED
• ANIE (National Federation of Electrotechnical and Electronic Enterprises): http://www.anie.it/; >> page on PED

Notified Bodies

• International Confederation of Inspection and Certification Organisations, CEOC International: http://www.ceoc.com/Default.aspx
• Bureau Veritas Italia: http://www.bureauveritas.it/wps/wcm/connect/bv_it/local; >> page on PED
• Consorzio Pascal: http://www.pascal-it.it/; >> page on PED
• HSB Global Standards (Hartford Steam Boiler): http://www.hsbglobalstandards.com/index.aspx; >> page on PED
• IIS (Istituto Italiano Saldatura): http://www.iis.it/, http://www.iiscert.it/; >> page on PED
• Lloyd’s Register: http://www.lr.org/; >> page on PED
• RINA: http://www.rina.org/IT/; >> page on PED
• TÜV SÜD Italia: http://www.tuv.it/it-it; >> page on PED

Other interesting portals

• NECSI – Ambiente Igiene Sicurezza
• www.marcaturace.com
• CEJN (quick connectors): http://www.cejn.it/; >> page on PED
• AriaCompressa, The rules for pressure equipment: http://www.ariacompressa.it/normative/A01.asp
• interFred (the Cooling portal): http://www.interfred.it/; >> page on PED
• United Kingdom, Heat Transfer Society (HTS): http://www.hts.org.uk/standards.htm
• UK-HSE: http://www.hse.gov.uk/pressure-systems/law.htm
• United Kingdom, DTI: http://www.dti.gov.uk/strd/pressure.html
• United Kingdom, Department for Business, Innovation & Skills: Pressure equipment manufacturers and their responsibilities: https://www.gov.uk/pressure-equipment-manufacturers-and-their-responsibilities
• INSTRKTIV, Pressure Equipment Directive (2014/68/UE) - Certification and CE Marking Guide: https://instrktiv.com/en/ped-pressure-equipment-directive/ 

Publications and Courses (in Italian only)

- Politecnico di Bari: Il rischio derivante dai fluidi in pressione - Politecnico di Bari: Esempio di un insieme PED - Maciga – Fossati, The “ped” directive for pressure equipment, obligations and implications for the maintenance, 2004 (>> text) - Management of pressure equipment and assemblies further to the related European Directive and the National laws, Course on organization and management of the company safety, Insubria University.