Principles, Standards and Implementation

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Regulations

Conformity Assessment

The designer or other responsible body must be able to show evidence that proves conformity with the EHSRs. This file should include all relevant information such as test results, drawings, specifications, etc., as shown below.

Figure 3: Document Assessment Results

A harmonized European (EN) Standard that is listed in the Official Journal of the European Union (OJ) under the Machinery Directive, and whose date of cessation of presumption of conformity has not expired, confers a presumption of conformity with certain of the EHSRs. (Many recent standards listed in the OJ include a cross-reference identifying the EHSRs covered by the standard.)

Therefore, where equipment complies with such current harmonized European standards, the task of demonstrating conformity with the EHSRs is greatly simplified, and the manufacturer also benefits from the increased legal certainty. These standards are not legally required, however, their use is strongly recommended since proving conformity by alternative methods can be an extremely complex issue. These standards support the Machinery Directive and are produced by CEN (the European Committee for Standardization) in cooperation with ISO, and CENELEC (the European Committee for Electrotechnical Standardization) in cooperation with IEC.

A thorough, documented risk assessment must be conducted to ensure all potential machine hazards are addressed. Similarly, it is the responsibility of the machine manufacturer to ensure all EHSRs are satisfied, even those that are not addressed by harmonized EN Standards.