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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

    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 ISO 11607-1:2009

    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 45502-2-3:2010

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

    Active implantable medical devices - Part 2-3: Particular requirements for cochlear and auditory brainstem implant systems

    EN ISO 13485:2016

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

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

    EN ISO 14155:2011

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

    Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2011)

    EN ISO 14155:2011/AC:2011

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

    Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2011)

    EN ISO 14937:2009

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

    Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, vali...

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