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EN 556-1:2001/AC:2006 Standard

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  Keywords:

#devices #medical #european #standard #specifies

  Directive

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

  Last Official Journal reference

Wednesday 14th of April 2021

  Description:

Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices

  Purpose

This European Standard specifies the requirements for a terminally-sterilized medical device to be designated 'STERILE': Part 2 of this European Standard specifies the requirements for an aseptically processed medical device to be designated "STERILE".

  Publication

Friday 17th of November 2017

  Correction

This standard is a correction for "EN 556-1:2001"

  Related Standards

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Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2002, including Amd...

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EN ISO 10993-1:2009

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

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

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