ISO 11135:2014

International Standard   Current Edition · Approved on 07 July 2014

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

ISO 11135:2014 Files

English 78 Pages
Current Edition
OMR 98.33

ISO 11135:2014 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.

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