Sound Engineering Practice Requirements

[Sean Vaidhyanathan]

Whenplacing on the market pressure equipment or assemblies of several pressure equipment connected by a manufacturer to form a coherent functional unit , covered by Article 4 (3) (good engineering practice), what information should be supplied to indicate that it complies with the provisions of Article 4 (3)?

However, the manufacturer must include sufficient instructions for use and affix a marking enabling the manufacturer or his authorised representative established within the Community to be identified.

Manufacturers should be aware that it is likely to be helpful if they accompany the product with a reference to the PED indicating that the requirements of good engineering practice in force in a Member State have been met.

The pressure equipment directive, sound engineering practice, and CE markings are all part of the European Union's Pressure Equipment Directive 97/23/EC (PED). Following several directives that dealt with pressure instruments, the European Union instated the PED 97/23/EC to set a common standard in design, production, testing, marking, and labelling of the pressurised equipment for manufacturers and operators.

PED is both aimed at ensuring all pressure equipment, and related equipment, is safe for use across the European Economic Area. The equipment subjected to the directive may include pressure vessels, pipes, safety components, and pressure accessories such as flange and nozzles.

Depending upon the type of fluid or gas, maximum allowable pressure, volume, and hazard level of the fluid or gas, pressure measuring components were subjected to different requirements, different in each country of the EU. This caused a wide range of trade difficulties with manufacturers having to seek multiple approvals to ensure local manufacturing and safety standards.

The Pressure Equipment Directive provides a common legal framework for pressure equipment manufacturers across the EU. The directive sets the common standard in the design, production, testing, marking, and labeling of the pressurized equipment and consists of:

The least hazardous is SEP, and the most hazardous is Category 4. With increasing hazards, quality assurance during design, manufacture, and testing will become more extensive. Following the quality assurance process, categories 1 to 4 will be marked with the CE mark. SEP products do not require the CE mark, it is also expressly forbidden to mark SEP-products with the CE mark.

Our introduction to the pressure equipment directive sets out the requirements and steps to be taken to assess whether or not a product should go through a quality assurance program for a CE marking, or whether the product is covered under SEP. PED is not intended for use in the United States. In the US, the ASME BPVC (American Society of Mechanical Engineers Boiler and Pressure Vessel Code) regulates the construction and design of pressure equipment.

The CE marking is required only for those products for which the EU specifications exist and must not be used for products that do not require it, such as SED-type products. The directive for each category specifies whether a third-party assessment is required or not for obtaining a CE marking. The equipment itself does not require any license to get the CE marking but must conform to the following rules:

Once the United Kingdom left the European Union in 2020, the PED entered a transitional phase in the United Kingdom that will see the introduction of the UK Conformity Assessed marking (UKCA). The CE mark will no longer be accepted on goods put on the market in Great Britain (England, Wales, Northern Ireland, and Scotland) after the 31st of December 2021.

UK companies that plan on placing pressure equipment in the European market will still need to put the CE mark on their products. However, these products must be approved by a body established in the European Union.

Sound Engineering Practice (SEP) (Art. 3, 3). Pressure equipment whose design or operating parameters fall below those of Category I must be designed and manufactured in accordance with the sound engineering practice of a Member State. SEP is indicated in the charts in Annex II. SEP equipment must not be CE marked.

Note: This information was obtained from the European Pressure Equipment Directive of the European Commission web site. The Inspectioneering Journal is not responsible for nor does it warrant the accuracy, completeness or validity of information contained in this article. It is the responsibility of readers to confirm the information with their jurisdictional regulatory bodies prior to use.

This document gives an overview about the structure and the contents of the Pressure Equipment Directive. The full text including Annexes is presented in the next sub-sections of the site. References and links are given for easier usability. It should be noted that the Pressure Equipment Directive has been published in the Official Journal of the European Communities and can be ordered from the Office for the official publications of the European Communities via the EUR-LEX site.

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 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.

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.

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.

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).

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.

The Directive applies to the design, manufacture and conformity assessment of pressure equipment and assemblies of pressure equipment with maximum allowable pressure greater than 0.5 bar above atmospheric pressure (i.e. 1,5 bar of absolute pressure)

Definitions (Article 1)

The term pressure equipment includes vessels, piping, safety accessories and pressure accessories. Where applicable, pressure equipment includes elements attached to pressurised parts, such as flanges, nozzles, couplings, supports, lifting lugs etc.

Member States of the EU may not, on the grounds of hazards due to pressure, prohibit, restrict or impede the placing on the market and putting into service of pressure equipment and assemblies which comply with the provisions of the PED. Member States are to presume that pressure equipment and assemblies bearing the CE marking and accompanied by the EC declaration of conformity satisfy the provisions of the PED.

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