This document gives a summary of the structure and the contents of the Pressure Equipment Directive. The full text including the annexes can be found at the following sections of the site. References and links are provided to facilitate use Please also note that the Pressure Equipment Directive was published in the Official Journal and can be ordered from the Publications Office of the European Communities via the EUR-LEX site. -Consolidated text INTRODUCTION
The Pressure Equipment Directive (97/23/EC) was adopted by the European Parliament and the European Council in May 1997. It has initially come into force on 29 November 1999. From that date until 28 May 2002 manufacturers have a choice between applying the pressure equipment directive or continuing with the application of the existing national legislation. From 29 May 2002 the pressure equipment directive will be obligatory throughout the European Union. The directive provides, together with the directives related to simple pressure vessels (87/404/EC), transportable pressure equipment (99/36/EC) and Aerosol Dispensers (75/324/EEC), for an adequate legislative framework on European level for equipment subject to a pressure hazard. The Directive arises from the European Community's Programme for the elimination of technical barriers to trade and is formulated under the "New Approach to Technical Harmonisation and Standards". Its purpose is to harmonise national laws of Member States regarding the design, manufacture, testing and conformity assessment of pressure equipment and assemblies of pressure equipment. It therefore aims to ensure the free placing on the market and putting into service of the equipment concerned within the European Union and the European Economic Area. Formulated under the New Approach the directive provides for a flexible regulatory environment that does not impose any detailed technical solution. This approach allows European industry to develop new techniques thereby increasing international competitiveness. The pressure equipment directive is one of a series of technical harmonisation directives for machinery, electrical equipment, medical devices, simple pressure vessels, gas appliances etc. The Directive concerns manufacturers of items such as vessels pressurised storage containers, heat exchangers, steam generators, boilers, industrial piping, safety devices and pressure accessories. Such pressure equipment is widely used in the process industries (oil & gas, chemical, pharmaceutical, plastics and rubber and the food and beverage industry), high temperature process industry (glass, paper and board), energy production and in the supply of utilities, heating, air conditioning and gas storage and transportation. Under the Community regime of the Directive, pressure equipment and assemblies above specified pressure and/or volume thresholds must: - be safe;
- meet essential safety requirements covering design, manufacture and testing;
- satisfy appropriate conformity assessment procedures; and
- carry the CE marking and other information.
Pressure equipment and assemblies below the specified pressure / volume thresholds must: - be safe;
- be designed and manufactured according to sound engineering practice; and
- bear specified markings (but not the CE marking).
The introduction of the new legislation related to pressure equipment concerns a large number of industries ranging from small and middle-sized manufacturers to the big chemical industries. Their total European market is estimated at more than 65 billions EURO per year. Both, manufacturers and users will benefit from the new regulatory environment as it will open up markets and, at the same time, facilitate the application of new technologies. The adaptation to the new directive will however necessitate considerable efforts by the manufacturers concerned. To ensure that the directive is understood and applied in a coherent manner the results of important work carried out on a European level need to be made available to economic operators and in particular to manufacturers. TERM USED
Essential safety requirements (ESRs) (Annex I) lay down the necessary safety elements for protecting public interest. Essential safety requirements for design, manufacture, testing, marking, labelling, instructions and materials, usually written in general terms, are mandatory and must be met before products may be placed on the market in the European Community. Conformity Assessment (Article 10) must be undertaken by the manufacturer or notified body, depending on the category of the equipment, in order to demonstrate that the essential safety requirements are met. Conformity Assessment Modules )(Annex III) The New Approach has introduced a modular approach to conformity assessment, thereby subdividing it into a number of independent activities. Modules differ according to the type of assessment (e.g. documentary checks, type approval, design approval, quality assurance) and the organisation carrying out the assessment (i.e. the manufacturer or a third party). Sound Engineering Practice (Article 3.3) applies to equipment that is not subject to conformity assessment but must be designed and manufactured in accordance with the sound engineering practice of a Member State in order to ensure safe use. That equipment must ensure that design and manufacture takes into account all relevant factors influencing safety during the intended lifetime. The equipment must be accompanied with adequate instructions for use and must bear the identification of the manufacturer. The responsibility for compliance with the PED lies solely with the manufacturer. Notified Body (Article 12) is a semi-official or private technical orgnisation appointed by Member States, either for approval and monitoring of the manufacturers' quality assurance system or for direct product inspection. A Notified Body may be specialised for certain products/product categories or for certain modules. Recognised Third Party Organisations (Article 13) are appointed by Member States to carry out the approval of welding procedures and personnel and non-destructive testing personnel User Inspectorates (Article 14) are appointed by Member States to carry out the tasks of notified bodies within their own companies under Modules A1, C1, F and G only. (The CE marking should not be affixed to pressure equipment and assemblies assessed by user inspectorates). CE Marking (Article 15 ) declares the completion of conformity assessment and that the equipment or assembly complies with the provisions of the Directive and meets the essential safety requirements. Published Harmonised (European) Standards (Article 5.2), list are a specific subset of European Standards (EN, produced by CEN and available from the national Standards Institutes) with particular consideration of the Essential Safety Requirements the reference number of which is published in the Official Journal of the European Commission. The use of a Published Harmonised Standard in the design and manufacture of a product will give the presumption of conformity (Article 5.1) to those ESRs listed in Annex ZA of the particular Harmonized Standard.
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