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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 ISO/FDIS 11135

General information

50.00   Final text received or FDIS registered for formal approval   May 12, 2026

ISO

ISO/TC 198 Sterilization of health care products

International Standard

11.080.01   Sterilization and disinfection in general

Scope

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.

Life cycle

PREVIOUSLY

PUBLISHED
ISO 11135:2014

PUBLISHED
ISO 11135:2014/Amd 1:2018

NOW

IN_DEVELOPMENT
ISO/FDIS 11135
50.00 Final text received or FDIS registered for formal approval
May 12, 2026




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