Committee Draft
ISO/CD 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/CD 11135
Edition 3
Committee Draft
ISO/CD 11135
90088
A draft is being reviewed by the committee.
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

  •  : Under development
    : CD approved for registration as DIS [30.99]
  •  : 3
  • ISO/TC 198
    11.080.01 
  • RSS updates

Sustainable Development Goals

This standard contributes to the following Sustainable Development Goal

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