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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

General information
Valid from 07.07.2014
Directives or regulations
None

Standard history

Status
Date
Type
Name
15.10.2018
Amendment
07.07.2014
Main
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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