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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

    Medical devices Directive (93/42/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 12342:1998+A1:2009

    Medical devices Directive (93/42/EEC)

    Breathing tubes intended for use with anaesthetic apparatus and ventilators

    EN ISO 10524-2:2006

    Medical devices Directive (93/42/EEC)

    Pressure regulators for use with medical gases - Part 2: Manifold and line pressure regulators (ISO 10524-2:2005)

    EN ISO 9713:2009

    Medical devices Directive (93/42/EEC)

    Neurosurgical implants - Self-closing intracranial aneurysm clips (ISO 9713:2002)

    EN ISO 10079-1:2009

    Medical devices Directive (93/42/EEC)

    Medical suction equipment - Part 1: Electrically powered suction equipment - Safety requirements (ISO 10079-1:1999)

    EN ISO 10079-2:2009

    Medical devices Directive (93/42/EEC)

    Medical suction equipment - Part 2: Manually powered suction equipment (ISO 10079-2:1999)

    EN ISO 10079-3:2009

    Medical devices Directive (93/42/EEC)

    Medical suction equipment - Part 3: Suction equipment powered from a vacuum or pressure source (ISO 10079-3:1999)

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