MARKING EC Directive 97/23 PED (Pressure Equipment Directive)

Transcription

1 MARKING EC Directive 97/23 PED (Pressure Equipment Directive)

2 Field of application The Directive applies to the design, manufacturing and conformity assessment of the pressure equipment and of their groups submitted to a maximum pressure greater than 0.5 bar. Coming into effect The Directive is in effect since November 1999 and envisages a transient period of two years and a half (optional application). On May 30th, 2002 the application of the Directive shall become compulsory within the EU and shall replace any national regulation/law currently in force in the single member states

3 Pressure equipment Containers Piping Safety accessories Pressure equipment Field of application: Assessment procedures: The Directive applies to the design, manufacturing and conformity assessment of the pressure equipment and of their groups submitted to a maximum pressure greater than 0.5 bar. The modules for assessing the conformity of the PED product are 13 (enclosure III) and describe the activities, tasks and responsibilities of the various parts involved, in particular, manufacturer and notified body, of each module: - Modules A and A1: internal manufacturing control and supervision of the final test - Module B and B1: EC examination of the type and EC examination of the design

4 THE DUTIES TO BE CARRIED OUT DEPEND ON: - TYPE OF FLUID (dangerous and non dangerous) - SYSTEM SPECIFICATIONS (pressure, volume, diameter) - FLUID NATURE (gas, steam or liquid) - TYPE OF EQUIPMENT (container, piping, safety device, etc ) The combination of these specifications grades the equipment in 4 different categories (I, II, III, IV)

5 EXAMPLE

6 The modules that can be used for each type of product under pressure must be provided among the four categories (I, II, III, IV) defined in 23/97 enclosure II: - Category I = Module A - Category II= Modules A1, D1, E1 - Category III= Modules B1+D, B1+F, B+E, B+C1, H - Category IV= Modules B+D, B+F, G, H1

7 Module A A1 B B1 C1 D D1 Description Internal manufacturing control (this is actually a self-certification of the container and of the manufacturing process) Internal manufacturing control and supervision of the final test (the previous rules apply; a notified body checks the final tests and the equipment without notice) EC examination of the type (a notified body checks the proper realisation of a specimen it also partially checks the manufacturing methods, like for example the qualification of the welders, the procedures used for the manufacturing processes, ) EC examination of the project (a notified body checks only the technical file of the project it also partially checks the manufacturing methods, like for example the qualification of the welders, the procedures used for the manufacturing processes, ) Type conformity (the manufacturer makes sure that the manufacturing process ensures the compliance of the produced tanks with what is certified in point B; a notified body checks the final control without notice) Production quality assurance (ISO9002 by a notified body; the competent body can make inspections without notice; in this way, the conformity of the production with the model examined in points B/B1 is guaranteed) Production quality assurance (ISO9002 by a notified body; the competent body can make inspections without notice; the design documentation is also examined during the inspection)

8 E E1 F G H H1 Product quality assurance (ISO9003 by a notified body; the competent body can make inspections without notice; in this way, the conformity of the production with the model examined in points B/B1 is guaranteed) Product quality assurance (ISO9003 by a notified body; the competent body can make inspections without notice; the design documentation is also examined during the inspection) Product verification (a notified body checks each product in order to establish its conformity with the prototype examined according to B/B1) EC verification of a single product (this examination is carried out by a competent body on each equipment produced) Total quality assurance (ISO 9001 by a notified body) Total quality assurance with design control and special supervision of the final test (apart from ISO 9001 by a notified body, the design must be examined by a notified body and the notified body checks the final test without notice).

9 The equipment forming the Categories from I to IV are subject: > to the procedures of risk assessment (grading the equipment) > to the declaration of conformity by the manufacturer > to the EC marking

10 CONFORMITY ASSESSMENT PROCEDURES IN THE COMMUNITY REGULATIONS Design Production A. Internal manufacturing control Keeps the technical document. at the disposal of the nation. authorities A. bis Intervention of the notified body A. - declares the conformity with the essential requirements A. bis - carries out tests on specific aspects of the product - checks the product at random intervals B. Standardisation The manufacturer submits to the notified body: - the technical documentation - the type The notified body: - assesses the conformity of the essential requirements - carries out the tests if necessary - issues the standardisation certificate C. Type Conformity -declares the conformity with the approved type - carries out tests on specific aspects of the product - checks the product at random intervals D. Production QA UNI EN ISO 9002 (9001:2000) - uses a quality system (QS) for production and testing -declares the conformity with the approved type - affixes the QS - checks the QS E. Production QA UNI EN ISO 9003 (9001:2000) - authorises a QS) approved for inspection and testing - declares the conformity with the type or with the essential requirements - affixes the QS - checks the QS F. Product verification -declares the conformity with the approved type or with the essential requirements - checks the conformity - issues the certificate of conformity G. Checking a single specimen - presents the technical documentation - presents the product - declares the conformity - checks the conformity with the essential requirements - issues the certificate of conformity H. Complete QA UNI EN ISO 9001 (9001:2000) - uses a QS system approved for the design - checks the QS - checks the conformity of the design - issues the EC certificate - uses a QS for production and testing - declares the conformity - affixes the EC brand - checks the QS system