ISO/FDIS 11135Under development

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

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

Abstract / 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

Replaces

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 ISO 11135:2014/Amd 1:2018PublishedSterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices — Amendment 1: Revision of Annex E, Single batch releaseInternational Standard · Published 15 Oct 2018 · ISO/TC 198