DS/CEN ISO/TS 11135-2/AC:2009 ( Withdrawn )

Sterilization of health care products - Ethylene oxide - Part 2: Guidance on the application of ISO 11135-1

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This Technical Specification provides guidance for the requirements in ISO 11135-1:2007. It does not repeat the requirements and is not intended to be used in isolation.
The exclusions in ISO 11135-1 apply also to this Technical Specification.
For ease of reference, the clause numbering in this Technical Specification corresponds to that in
ISO 11135-1:2007. Further guidance for the requirements given in ISO 11135-1 is also included in Annex C of ISO 11135-1:2007 and should be used in conjunction with this Technical Specification.
This guidance document is intended for people who have a basic knowledge of the principles of EO
sterilization but may need help in determining how to best meet the requirements contained in ISO 11135-1.
This document is not intended for people lacking a basic knowledge of the principles of EO sterilization.

Number of pages: 8

Published: 2009-05-29

Date of approval: 2009-05-11

Date of withdrawal: 2017-07-31

International relationships : CEN ISO/TS 11135-2:2008/AC:2009 IDT ISO/TS 11135-2:2008/Cor 1:2009 IDT

ICS: 11.080.01 - Sterilization and disinfection in general

Item number: M239505



  • CEN/TC 204
  • ISO/TC 198/WG 1

Danish committee