KAN Report 33
|Standardization pursuant to Directive 94/9/EC (ATEX), 09/2004, EXAM BBG Prüf- und Zertifizier GmbH (1008 KB)|
Bookmarks in the pdf file link directly to the individual chapters.
|Report of the project contractor (741 KB)|
The object of the study is the examination of possible deficits in standards pur-suant to Directive 94/9/EC of the European Parliament and of the Council on the approximation of the laws of the Member States concerning equipment and protective systems intended for use in potentially explosive atmospheres.
The Contractor is EXAM BBG Prüf- und Zertifizier GmbH, Bochum
On 30 June 2003, the transitional period expired for transposition of Directive 94/9/EC concerning equipment and protective systems intended for use in potentially explosive atmospheres. Since this date, equipment and protective systems may be placed on the market and put into service only if they meet the essential health and safety requirements set out in Annex II of the directive (in conjunction with the conformity assessment procedures under Article 8). One result of a survey commissioned by KAN in 1998 was that a random analysis revealed deficits in standards and draft standards. A need for systematic analysis from an occupational health and safety perspective was thus perceived.
The examination was conducted over a period of six months as follows:
- survey of the current state of European standardization pursuant to Direc-tive 94/9/EC;
- description of the existing level of safety in Germany;
- structured interviews with users of standards and with experts;
- comparison between the essential requirements of Annex II of the directive and the content of standards in their present form;
- identification of duplicate provisions, overlap and contradictions;
- comparison of the content of the standards with the existing level of safety in Germany;
- identification of areas not supported by standards projects;
- discussion of results in the project support group.
For examination of these potential deficits, over 70 CEN and CENELEC standards (refer to the annex of the study) were evaluated as far as possible against check-lists for their compliance with Annex II of Directive 94/9/EC, experts and users of standards were consulted, and literature surveys and database searches were conducted.
Overall, the requirements of the directive were found on the whole to have been implemented in the harmonized standards under consideration, and the existing level of safety in Germany to be preserved by European standards. Full imple-mentation of the essential requirements under consideration could not however be confirmed in any of the evaluated standards. Yet it should be pointed out that the deficits resulting in a lower evaluation result for the standards were frequently minor. Of particular note is that certain requirements exist which as yet have been poorly detailed in standards: examples include misuse, marking, and the aspect of instructions as part of the manufacturer/operator interface, the concept of lifetime (for example the ageing of materials (plastics)), etc.
Furthermore, a whole range of deficits exist in individual standards with respect to the directive and between the standards themselves.
Greater attention should therefore be paid to the claim of a harmonized standard to the presumption of conformity. A situation must at all costs be avoided in which the essential requirements falling within the scope of a standard but not supported or addressed by it are overlooked or neglected by the user of the standard; this is to be achieved through reference to the requirements not ad-dressed in the standard by the inclusion of relevant information in the introduc-tion, scope, or appropriate sections of the standard. Annex ZA is favoured for this purpose by the users of standards and by certain experts as an informative supplement to a standard by which the latter can be related correctly to Directive 94/9/EC and implementation of the essential requirements of Annex II 94/9/EC facilitated. Care should however be exercised in the creation of this annex, and the standards committees should be provided with a suitably well prepared model document. This problem is not exclusive to Directive 94/9/EC, however, but probably concerns all New Approach directives.
Standards frequently appear at first sight not to correspond to the first essential requirement under Annex II No. 1.0.1. of the directive concerning observance of the ranking of explosion protection principles. This aspect in fact frequently lies outside the scope of a standard, as for example in the case of standards governing the avoidance of explosion hazards. At the same time, stan-dards are expected to detail the ranking of protective measures according to the principle of integrated explosion safety. This deficit could at least be alleviated by a suitable comment, as with the claim of a harmonized standard to give rise to the presumption of conformity.
Altogether, the body of standards in the non-electrical sphere is incomplete, and detailed examination reveals contradictions or errors. Considerable standardization activity (development of standards and first revision) thus remains to be completed in this area. The interviews repeatedly revealed that an insufficient number of experts (in particular manufacturers) are involved in the drafting of standards. For this reason, and owing to its novelty and complexity, the body of standards in the non-electrical sphere is considered very poorly structured. This is the view not only of manufacturers, but also of test bodies.
The body of standards in the electrical sphere exhibits far fewer contradictions or detail errors. With the exception of the absence of requirements for safety devices for example of pressurized apparatus or protective motor switches, the provisions correspond very closely to the requirements of Directive 94/9/EC. The majority of electrical standards have a long history, through which they have acquired a safety status which is broadly accepted. Since precursory arrangements to Directive 94/9/EC exhibit comparable provisions for many areas of electrical explosion protection, for example regarding obligatory testing by notified bodies, the continuity to Directive 94/9/EC in the sphere of electrical explosion protection is high. The new requirements formulated by the directive concerning quality assurance further assure a high quality standard among manufacturers and should for this reason be regarded as progress.
The results of the checklist evaluation of the harmonized standards and standards projects are presented in the table.