ISO-11135 › Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices

ISO-11135 - 2ND EDITION - CURRENT
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 2ND EDITION - July 7, 2014
 FOR 2ND EDITION AMENDMENT 1 SEE - Oct. 1, 2018

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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Document Number

ISO 11135:2014

Revision Level

2ND EDITION

Status

Current

Publication Date

July 7, 2014

Committee Number

ISO/TC 198