ISO-11135 › Historical Revision Information
Amendment 1: Revision of Annex E, Single batch release

ISO-11135 - FOR 2ND EDITION AMENDMENT 1 SEE - CURRENT
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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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11.080.01 (Sterilization and disinfection in general Including sterilization methods, air quality of surgery rooms, etc.)

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Document Number

ISO-11135

Revision Level

FOR 2ND EDITION AMENDMENT 1 SEE

Status

Current

Publication Date

Oct. 1, 2018

Committee Number

ISO/TC 198