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

Current stage: 90.92 Effective date: Jul 22, 2020

Originator: ISO

Owner: ISO/TC 198

Type: International Standard

ICS: 11.080.01

Languages: English French

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Status: Published

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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

Revises
ISO 11135-1:2007

Revises
ISO/TS 11135-2:2008

NOW

PUBLISHED
ISO 11135:2014
90.92 Standard to be revised
Jul 22, 2020

CORRIGENDA / AMENDMENTS

Amended by
ISO 11135:2014/Amd 1:2018

REVISED BY

IN_DEVELOPMENT
ISO/DIS 11135

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