Reference number
ISO 11135:2014
© ISO 2025
International Standard
ISO 11135:2014
Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices
Edition 2
2014-07
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Published (Edition 2, 2014)
This publication was last reviewed and confirmed in 2024. Therefore this version remains current.

ISO 11135:2014

Language
Format
CHF 199
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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
     : Published
    Publication date
     : 2014-07
    Stage
    : International Standard to be revised [90.92]
  • Edition
     : 2
    Number of pages
     : 78
  • Technical Committee :
    ISO/TC 198
    ICS :
    11.080.01 
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 Amendments

Amendments are issued when it is found that new material may need to be added to an existing standardization document. They may also include editorial or technical corrections to be applied to the existing document.

Amendment 1

Revision of Annex E, Single batch release

Edition 2018

Language
Format
CHF 18
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Life cycle

Sustainable Development Goals

This standard contributes to the following Sustainable Development Goal

3
Good Health and Well-being

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