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.

Begin

2024-07-23

WI

00204094

Planned document number

FprEN ISO 11135

Responsible national committee

NA 176-03-09 AA - Sterilization and processing of medical devices  

Responsible european committee

CEN/TC 204 - Sterilization of medical devices  

draft standard

Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO/FDIS 11135:2026)
2026-09
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previous edition(s)

Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices - Amendment 1: Revision of Annex E, Single batch release (ISO 11135:2014/Amd 1:2018)
2019-11

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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)
2014-07

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