Approved Work Item
ISO/AWI TS 25462
Sterilization of health care products — Ethylene oxide — Guidance on the validation and routine processing of sterilization processes using alternative approach to parametric release
Reference number
ISO/AWI TS 25462
Edition 1
© ISO 2025
Approved Work Item
Under development
A working group has prepared a draft.

Abstract

This document provides guidance on an alternative approach to parametric release which would be supplemental to the method described in the requirements of ISO 11135:2014 that apply when parametric release is used to release the product after exposure to the ethylene oxide sterilization process It provides a path for transition of existing ethylene oxide sterilization cycles, as well as a path for the development and implementation of a parametric release specification for a new ethylene oxide sterilization cycle. Additionally, it highlights the advantages/disadvantages of this method versus the existing ISO 11135 requirements and the application of risk assessment.

General information

  • Status
     : Under development
    Stage
    : New project registered in TC/SC work programme [20.00]
  • Edition
     : 1
  • Technical Committee :
    ISO/TC 198
  • 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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