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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

    In vitro diagnostic medical devices Directive (98/79/EC)

      Last Official Journal reference

    Thursday 15th 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

    In vitro diagnostic medical devices Directive (98/79/EC)

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

    EN 556-2:2015

    In vitro diagnostic medical devices Directive (98/79/EC)

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

    EN ISO 11137-1:2015

    In vitro diagnostic medical devices Directive (98/79/EC)

    Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a ster...

    EN ISO 11137-2:2015

    In vitro diagnostic medical devices Directive (98/79/EC)

    Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013)

    EN ISO 11737-2:2009

    In vitro diagnostic medical devices Directive (98/79/EC)

    Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation an...

    EN 12322:1999

    In vitro diagnostic medical devices Directive (98/79/EC)

    In vitro diagnostic medical devices - Culture media for microbiology - Performance criteria for culture media

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