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EN ISO 10993-1:2009/AC:2010 Standard

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  Keywords:

#corrigendum #process #management #risk #testing

  Directive

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

  Last Official Journal reference

Wednesday 14th of April 2021

  Description:

Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2009)

  Purpose

Corrigendum to EN ISO 10993-1:2009.

  Publication

Friday 17th of November 2017

  Correction

This standard is a correction for "EN ISO 10993-1:2009"

  Related Standards

EN 556-1:2001

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

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EN ISO 13408-2:2018

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Aseptic processing of health care products - Part 2: Sterilizing filtration (ISO 13408-2:2018)

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 ...

EN ISO 14155:2020

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

EN ISO 11607-1:2020

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

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

EN ISO 10993-18:2020

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

Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management...

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