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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

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Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products (...

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Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging sy...

EN ISO 14155:2020

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Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020)

EN ISO 11607-2:2020

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Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes ...

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