Need help?

EN ISO 11137-1:2015 Standard

wave
Save  

  Keywords:

#devices #medical #process #sterilization #control

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

    In vitro diagnostic medical devices Regulation ((EU) 2017/746)

      Last Official Journal reference

    Wednesday 28th of January 2026

      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

    Tuesday 20th of July 2021

      Related Standards

    EN ISO 14971:2019/A11:2021

    In vitro diagnostic medical devices Regulation ((EU) 2017/746)

    Medical devices - Application of risk management to medical devices (ISO 14971:2019)

    EN ISO 13485:2016/A11:2021

    In vitro diagnostic medical devices Regulation ((EU) 2017/746)

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

    EN ISO 11737-2:2020

    In vitro diagnostic medical devices Regulation ((EU) 2017/746)

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

    EN ISO 13408-1:2024

    In vitro diagnostic medical devices Regulation ((EU) 2017/746)

    Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2023)

    EN ISO 20916:2024

    In vitro diagnostic medical devices Regulation ((EU) 2017/746)

    In vitro diagnostic medical devices - Clinical performance studies using specimens from human subjects - Good study practice (ISO ...

    EN ISO 17511:2021

    In vitro diagnostic medical devices Regulation ((EU) 2017/746)

    In vitro diagnostic medical devices - Requirements for establishing metrological traceability of values assigned to calibrators, t...

      Stay up to date

      ACCESS

    Search for a standard
    GO

    Register

    Already a member?
    Login

      OTHER APPLICATIONS

    If you are interested in DO160 tests, you can give a try to our other free of charge software:
    CE-Marking assistant, Version: 1.3.0