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EN 45502-1:1997 Standard

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  Keywords:

#medical #active #implantable #particular #devices

  Directive

Active implantable medical devices Directive (90/385/EEC)

  Last Official Journal reference

Wednesday 14th of April 2021

  Description:

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

  Purpose

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.

  Publication

Friday 17th of November 2017

  Related Standards

EN ISO 11737-2:2009

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EN 60601-1:2006/A1:2013

Active implantable medical devices Directive (90/385/EEC)

Medical electrical equipment - Part 1: General requirements for basic safety and essential performanceIEC 60601-1:2005

EN ISO 13485:2016

Active implantable medical devices Directive (90/385/EEC)

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)

EN ISO 14155:2011

Active implantable medical devices Directive (90/385/EEC)

Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2011)

EN ISO 14155:2011/AC:2011

Active implantable medical devices Directive (90/385/EEC)

Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2011)

EN ISO 14937:2009

Active implantable medical devices Directive (90/385/EEC)

Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, vali...

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