Final Draft
International Standard
ISO/FDIS 11135
Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices
Reference number
ISO/FDIS 11135
Edition 3
© ISO 2026
Final Draft International Standard
Under development
This draft is in the approval phase.
Will replace ISO 11135:2014

Abstract

ISO 11135:2014 specifies requirements for the development, validation and routine control of an ethylene oxide sterilization process for medical devices in both the industrial and health care facility settings, and it acknowledges the similarities and differences between the two applications.

General information

  • Status
     : Under development
    Stage
    : Final text received or FDIS registered for formal approval [50.00]
  • Edition
     : 3
  • Technical Committee :
    ISO/TC 198
    ICS :
    11.080.01 
  • RSS updates

Life cycle

Sustainable Development Goals

This standard contributes to the following Sustainable Development Goal

3
Good Health and Well-being

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