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EN ISO 14155:2011/AC:2011 Standard

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  Keywords:

#corrigendum #devices #practice #clinical #good

This standard is superseded by:
  •   EN ISO 14155:2020
  •   This standard is no longer addressed in the last official Journal publication of the "2021-04-14 ". This standard is addressed for the last time in the official journal publication of the "2020-03-25"

      Directive

    Medical devices Directive (93/42/EEC)

      Last Official Journal reference

    Wednesday 25th of March 2020

      Description:

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

      Purpose

    Corrigendum to EN ISO 14155:2011.

      Publication

    Friday 17th of November 2017

      Cessation

    This standard has been withdrawn on 2021-04-14

      Correction

    This standard is a correction for "EN ISO 14155:2011"

      Related Standards

    EN ISO 10993-7:2008

    Medical devices Directive (93/42/EEC)

    Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008)

    EN ISO 14937:2009

    Medical devices Directive (93/42/EEC)

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

    EN ISO 11607-1:2020

    Medical devices Directive (93/42/EEC)

    Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging sy...

    EN ISO 11607-2:2020

    Medical devices Directive (93/42/EEC)

    Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes ...

    EN ISO 11737-2:2020

    Medical devices Directive (93/42/EEC)

    Sterilization of health care products - Microbiological methods - Part 2: Tests of sterility performed in the definition, validati...

    EN ISO 14155:2020

    Medical devices Directive (93/42/EEC)

    Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020)

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