Need help?

EN ISO 11135:2014 Standard

wave
Save  

  Keywords:

#eu #relationship #essential #directive #performance

This standard can be totally or partially supervised by:
  •   EN ISO 11135:2014/A1:2019
  •   Directive

    Medical devices Regulation ((EU) 2017/745)

      Last Official Journal reference

    Thursday 11th of June 2026

      Description:

    Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 11135:2014)

      Purpose

    ISO 11135 describes requirements for the ethylene oxide sterilization process for medical devices in both industrial and healthcare facility settings. Compliance with ISO 11135 ensures products that meet the defined requirements for sterile products with a high degree of confidence. EN ISO 11135:2014/A1:2019 modifies the European standard EN ISO 11135:2014. The main text and the amendment can be found in the standard’s history. In this amendment you can find the following: — Relationship between EN ISO 11135 and the Essential Requirements of EU Directive 90/385/EEC on active implantable medical devices,— Relationship between EN ISO 11135 and the Essential Requirements of EU Directive 93/42/EEC on medical devices,— Relationship between EN ISO 11135 and the Essential Requirements of EU Directive 98/79/EC on in vitro diagnostic medical devices,— Relationship between EN ISO 11135 and the General Safety and Performance Requirements of Regulation (EU) 2017/745,— Relationship between EN ISO 11135 and the General Safety and Performance Requirements of Regulation (EU) 2017/746,— Annex E (which specifies the release of a product from a single batch sterilization process).

      Publication

    Monday 19th of July 2021

      Related Standards

    EN ISO 11607-2:2020

    Medical devices Regulation ((EU) 2017/745)

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

    EN 13795-1:2025

    Medical devices Regulation ((EU) 2017/745)

    Surgical clothing and drapes - Requirements and test methods - Part 1: Surgical drapes and gowns

    EN ISO 21535:2024

    Medical devices Regulation ((EU) 2017/745)

    Non-active surgical implants - Joint replacement implants - Specific requirements for hip-joint replacement implants (ISO 21535:20...

    EN ISO 18562-4:2024

    Medical devices Regulation ((EU) 2017/745)

    Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 4: Tests for leachables in condensate (ISO...

    EN ISO 18562-3:2024

    Medical devices Regulation ((EU) 2017/745)

    Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 3: Tests for emissions of volatile organic...

    EN ISO 18562-2:2024

    Medical devices Regulation ((EU) 2017/745)

    Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 2: Tests for emissions of particulate matt...

      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