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EVS-EN 45502-1:2000

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Active implantable medical devices - Part 1: General requirements for safety, marking and information to be provided by the manufacturer

This part of EN 45502 specifies requirements that are generally applicable to ACTIVE IMPLANTABLE MEDICAL DEVICES. For particular types of ACTIVE IMPLANTABLE MEDICAL DEVICES, these essential requirements are supplemented or modified by the requirements of particular standards which form additional parts of this European Standard.

Although the standard’s status is withdrawn, it still has the presumption of conformity in the meaning of directive 90/385/EEC and conformance with the directive’s requirements can be guaranteed by using the withdrawn version of the standard. The presumption of conformity is valid until a corresponding amendment is published in the Official Journal of the European Union.
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