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Active implantable standards in EU OJ (Official Journal):

This article was originally published in Clinica

Executive Summary

The European Commission has published a near-comprehensive list of standards in the Official Journal of the European Union that companies can use to aid compliance with the Active Implantable Medical Devices Directive (AIMDD). These are all standards with which compliance is assumed to mean that the manufacturer has met the relevant essential requirements of the AIMDD. Many of the standards, or parts of them, published in the OJ (C153) on June 24 supersede previous standards. The OJ notes that publication of the references does not imply that the standards are available in all Community languages.

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