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EN ISO 11137-1:2015 Standard

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  Keywords:

#devices #medical #process #sterilization #control

This standard is superseded by:
  •   EN ISO 11137-1:2015/A2:2019
  • This standard can be totally or partially supervised by:
  •   EN ISO 11137-1:2015/A2:2019
  •   Directive

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

      Last Official Journal reference

    Monday 19th of July 2021

      Description:

    Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006, including Amd 1:2013)

      Purpose

    Amendment for EN ISO 11137-1:2015

      Publication

    Friday 17th of November 2017

      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 ISO 11137-1:2015/A2:2019

    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 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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