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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

    Friday 17th of November 2017

      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 15193:2009

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

    In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for content and pre...

    EN ISO 17511:2003

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

    In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values assign...

    EN 13612:2002/AC:2002

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

    Performance evaluation of in vitro diagnostic medical devices

    EN 13641:2002

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

    Elimination or reduction of risk of infection related to in vitro diagnostic reagents

    EN 13975:2003

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

    Sampling procedures used for acceptance testing of in vitro diagnostic medical devices - Statistical aspects

    EN 14136:2004

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

    Use of external quality assessment schemes in the assessment of the performance of in vitro diagnostic examination procedures

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