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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

General information

50.00     May 12, 2026

ISO

ISO/TC 198

International Standard

11.080.01  

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

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

National adoptions

naSRPS EN ISO 11135:2024  
ISS

Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO/DIS 11135:2025)

40.60   Close of voting

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