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EN 556-1:2001 Standard

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  Keywords:

#medical #devices #european #standard #specifies

This standard can be totally or partially supervised by:
  •   EN 556-1:2001/AC:2006
  •   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

      Reference

    This standard supersedes the "EN 556:1994 + A1:1998"

    Anyway is still possible use the "EN 556:1994 + A1:1998" until April 30th, 2002

      Related Standards

    EN 556-1:2001/AC:2006

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

    Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminal...

    EN 556-2:2015

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

    Sterilization of medical devices - Requirements for medical devices to be designated ''STERILE" - Part 2: Requirements for aseptic...

    EN 1041:2008

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

    Information supplied by the manufacturer of medical devices

    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)

    EN ISO 10993-1:2009/AC:2010

    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)

    EN ISO 10993-3:2014

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

    Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:...

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