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European Pressure Equipment Directive – 97/23/EC

Pressure equipment is vital in containing energy for use in all manner of technologies. Look around you, electrical generation, food processing, brewing, and numerous other processes which we take for granted all impact on our every day existence.

Experience has taught us that pressure equipment is dangerous and expensive in terms of human life and loss of property should it fail in a catastrophic manner. Industrial history is littered with tragic events relating to explosions and sudden releases of pressure from such equipment.

Down the years economics has driven the need to develop higher pressures and reduce the scale of plant. Statistically speaking, failures from pressure equipment are inevitable. Consequently, when failures do occur, they may be catastrophic unless proper consideration has been given to hazard control.

 

Different countries countered the potential hazards from pressure equipment in different ways. However, the principal general method was to introduce rules for the design, construction and testing of new pressure equipment together with rules for in-service operation and periodic testing. As might be expected, these rules developed differently from country to country based on their individual culture and experiences. The technology of pressure equipment is complex and has been distilled in terms of national codes of practice and standards. Some countries cite their codes of practice and who is responsible for ensuring their compliance in terms of the law, whilst other countries rely on the voluntary adoption of such best practice.

It follows, that whilst pressure equipment technology remained similar, considerable difficulties, or indeed impossibilities, were experienced in exporting pressure equipment made in one country for use in another. The Pressure Equipment Directive [PED] has provided a harmonised approach to resolving this problem within the European Economic Area, “EU”, thereby removing barriers to trade.

The PED is an agreement between European Member States to enact National legislation on manufacturer’s producing new pressure equipment. The PED does not set rules for the design and construction of pressure equipment per se, but affords a framework based on the hazard presented by the equipment due to pressure and fluid danger, on which applicable Essential Safety Requirements are to be met. These essential requirements are no more onerous than a competent pressure equipment manufacturer would have to address in designing, manufacturing, inspecting and testing in the normal course of events. However, the obligations are now placed on the manufacturer and not the user to ensure the safety of new equipment.

PED Requirements:

When the design pressure of the equipment exceeds 0,5 bar (note that there are some exceptions), the legislation obliges:

the Manufacturer to:

  • apply the requirements of the directive as applicable to the design, manufacture, final inspection and testing of their pressure equipment products
  • be subjected as applicable to the surveillance of a Notified Body such as Moody International.
  • draw up technical documentation which enables others to assess the conformity of the pressure equipment with the requirements of the Directive which apply to it
  • apply “CE” marking to each item of pressure equipment following certification by the Notified Body
  • draw up a written declaration of conformity
  • retain the technical documentation and declaration of conformity for a period of ten years
  • take all necessary measures to ensure that ongoing design, manufacture, final inspection and testing complies with the provisions of the Directive.

The legislation obliges the Notified Body (Moody International) to:

  • be appointed by a Member State (Moody International ID No. = 1277 )
  • be listed in the official Journal of European Communities with identification number for the tasks so Notified.
  • be independent of marketing, design, manufacture, supply, installation, use and maintenance of the pressure equipment
  • carry out assessments and verifications according to the PED with the highest degree of professional integrity and technical competence free of financial inducements and pressures
  • have at its disposal the necessary resources to carry out inspections and surveillance
  • have responsible inspection personnel with sound and vocational training, knowledge and experience of the inspections to be performed, the ability to draw-up certification and reports demonstrating that the inspections have been performed
  • be impartial
  • hold relevant liability insurance
  • observe strict confidentiality, except with respect to the Member State enforcing authority
  • provide exchanges of technical information with the manufacturer so as take account of the state of the art and current practice, as well as technical and economic considerations which are consistent with a high degree of health and safety

It must be noted that there are criminal penalties involved for manufacturers failing to comply with the legislation. Similarly, the liability may extend to persons other than the principal offender, particularly the Notified Body unless the defence of due diligence can be established.

Further, it is to be noted that:

  • “CE” marking is not a quality mark, but a European Safety Mark, taking the initials from “Conformite Europeene”.
  • The application of such marking requires that the manufacturer shall have assessed the simultaneous application of other European Directives as applicable to the product or assembly.

Already Purchasers outside the European Economic Area are specifying that products shall bear “CE” marking to better define the level of safety they require.

Internal Training in order to offer PED Notified Body Services:

Moody International currently hold the following accreditation from the Department of Trade and Industry as assessed by the United Kingdom Accreditation Service (UKAS) under identification No. 1277.:

Product :
Pressure equipment and assemblies except for portable fire extinguishers and bottles for breathing apparatus
Procedures Annexes
Approval of permanent joining personnel Annex I, 3.1.2
Approval of permanent joining procedures Annex I, 3.1.2
Conformity to type Annex III - Module C1
EC Type-examination Annex III - Module B
EC design-examination Annex III - Module B1
EC unit verification Annex III - Module G
Full quality assurance Annex III - Module H
Full quality assurance with design examination and special surveillance of the final assessment Annex III - Module H1
Internal manufacturing checks with monitoring of the final assessment Annex III - Module A1
Product quality assurance Annex III - Module E
Product quality assurance Annex III - Module E1
Product verification Annex III - Module F
Production quality assurance Annex III - Module D
Production quality assurance Annex III - Module D1

Moody International is a worldwide quality organisation with over 80 office’s worldwide providing comprehensive certification and Notified Body / CE Mark / PED services in addition to ISO 9001, ISO 14001, TS 16949, OHSAS & HACCP certification.

The following table compares PED versus ASME - Approximate Comparison

PED

ASME

  • European Directive 97/23/EC
  • Federal Law
  • Member State Law

(e.g. UK, Germany, France etc.) Pressure Equipment Regulations.

  • State Law
  • European harmonised Standards ? Norms

Give presumption of conformity for Essential Safety Requirements (ESR) of PED Annex I

(e.g. EN 12952 ? Water Tube Boilers

EN 13445 - Unfired Pressure Vessels)

  • Other Standards may be adopted provided that it is demonstrated that the PED ESRs are met.
  • Codes recognised by Law

e.g. ASME Section I

ASME Section VIII/1

  • Member State Department responsible for Notification
    • Accrediting Body assesses potential Conformity Assessment Bodies (CAB?s i.e. Moody International) against PED requirements.
      • Accreditation against EN 45 000 Standards covers:
        • Management Structure
        • Quality System
        • Personnel ? Design Examination, Inspection, Welding, NDT, etc.
        • Laboratory and testing equipment, etc.
  • NBPV Inspectors
    • Certifies Inspection Agencies
    • Qualifies Inspectors
  • Notified Bodies (Conformity Assessment Body ? CAB)
    • Certifies Manufacturers PED Quality Systems for production under the quality conformity assessment procedure routes.
    • On-going surveillance of Manufacturers Quality Systems
    • Unexpected visits
    • Witness final assessments for Cat. IV equipment and one offs.
  • NBPV Inspectors
    • Certifies Manufacturers
    • Issues Stamps
  • Notified Bodies
    • Performs Design Examinations
    • Performs Inspections for production under the inspection conformity assessment routes.
    • Issues Certificates of Conformity
  • Code Inspection Agencies
    • Perform Inspections
    • Endorse Manufacturers Certification
  • Notified Bodies or Recognised Third Parties
    • Certify Welding Procedures and Welders
    • Certify NDT Personnel
  • Manufacturers
    • Approve Welders
    • Approve NDT Personnel
  • Manufactures apply ?CE? Marking and Notified Body unique identification (Moody International = 1277) number following issue of Notified Body certification of conformity.
  • Manufacturer applies Code Stamp
  • Manufacturer draws up a Declaration of Conformity
  • Manufacturers Draws up Certification
  • Manufacturers retain documentation for at least ten years at the disposal of Member State authorities.
  • Manufacturers compile data dossier.

Inspection & Procurement Support Services

 

 


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