ISO 11135-1:2007Withdrawn

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

Stérilisation des produits de santé — Oxyde d'éthylène — Partie 1: Exigences de développement, de validation et de contrôle de routine d'un processus de stérilisation pour des dispositifs médicaux

This edition has been replaced by ISO 11135:2014.

Abstract / 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

Replaces

ISO 11135:1994WithdrawnMedical devices — Validation and routine control of ethylene oxide sterilizationInternational Standard · Published 27 Jan 1994 · ISO/TC 198 ISO 11135:1994/Cor 1:1994WithdrawnMedical devices — Validation and routine control of ethylene oxide sterilization — Technical Corrigendum 1International Standard · Published 27 Oct 1994 · ISO/TC 198

Replaced by

ISO 11135:2014PublishedSterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devicesInternational Standard · Published 7 Jul 2014 · ISO/TC 198