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EVS-EN 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 (ISO 11135:2014)

General information
Valid from 04.08.2014
Base Documents
ISO 11135:2014; EN ISO 11135:2014
Standard history
Status
Date
Type
Name
02.12.2019
Amendment
04.08.2014
Main
07.05.2009
Corrigendum
09.01.2009
Main
04.07.2007
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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Standard monitoring
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