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ISO 11135-1:2007

Sterilization of health care products — Ethylene oxide — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices

95.99 Withdrawal of Standard   Jul 7, 2014

General information

95.99     Jul 7, 2014

ISO

ISO/TC 198

International Standard

11.080.01  

Scope

ISO 11135-1:2007 specifies requirements for the development, validation and routine control of an ethylene oxide sterilization process for medical devices.
Sterilization processes validated and controlled in accordance with the requirements of ISO 11135-1:2007 are not assumed to be effective in inactivating the causative agents of spongiform encephalopathies such as scrapie, bovine spongiform encephalopathy and Creutzfeld Jacob disease. Specific recommendations have been produced in particular countries for the processing of materials potentially contaminated with these agents.

Life cycle

PREVIOUSLY

Revises
ISO 11135:1994

Revises
ISO 11135:1994/Cor 1:1994

NOW

WITHDRAWN
ISO 11135-1:2007
95.99 Withdrawal of Standard
Jul 7, 2014

REVISED BY

PUBLISHED
ISO 11135:2014

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