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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

Publication date:   Jul 7, 2014

General information

90.92 Standard to be revised   Jul 22, 2024

ISO

ISO/TC 198 Sterilization of health care products

International Standard

11.080.01   Sterilization and disinfection in general

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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

WITHDRAWN
ISO 11135-1:2007

WITHDRAWN
ISO/TS 11135-2:2008

NOW

PUBLISHED
ISO 11135:2014
90.92 Standard to be revised
Jul 22, 2024

CORRIGENDA / AMENDMENTS

PUBLISHED
ISO 11135:2014/Amd 1:2018

REVISED BY

ABANDON
ISO/DIS 11135

IN_DEVELOPMENT
ISO/CD 11135