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Rules - MDD European Harmonized StandardsToday there are almost a hundred European, harmonized standards for medical devices which reflect the requirements of the Directives in a more specific and detailed way.These standards have been prepared by the European standardization bodies CEN and CENELEC and follow a mandate issued by the European Commission. Provided that the manufacturer complies with these standards the requirements in the Directive, which the standards concern, are automatically fulfilled. Examples of these harmonized standards for the products are EN 60601 on Electric Security, EN 60601-1-2 on Electromagnetic Compatibility (EMC) and the series EN 550/54/56 on Sterility. However, it is up to the manufacturers to decide if they wish to follow the standards or if they in another way are able to prove that the requirements have been fulfilled. Back to index |
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