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EN 556-1:2001 Standard

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  Keywords:

#devices #medical #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

    Wednesday 25th of March 2020

      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 superseed the "EN 556:1994 + A1:1998"

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

      Related Standards

    EN ISO 18113-4:2011

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

    In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents ...

    EN ISO 13408-4:2011

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

    Aseptic processing of health care products - Part 4: Clean-in-place technologies (ISO 13408-4:2005)

    EN 13612:2002/AC:2002

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

    Performance evaluation of in vitro diagnostic medical devices

    EN 13612:2002

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

    Performance evaluation of in vitro diagnostic medical devices

    EN 13532:2002

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

    General requirements for in vitro diagnostic medical devices for self-testing

    EN ISO 13485:2016/AC:2016

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

    Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)

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