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EN ISO 11135:2014 Standard

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  Keywords:

#eu #relationship #essential #directive #performance

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

    Tuesday 20th of July 2021

      Related Standards

    EN ISO 11135:2014/A1:2019

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

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    EN ISO 14971:2019/A11:2021

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    EN ISO 14971:2019

    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

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

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