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BSI DD CEN ISO/TS 11135-2:2008

Sterilization of health care products. Ethylene oxide -- Guidance on the application of ISO 11135-1
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BSI DD CEN ISO/TS 11135-2:2008

Sterilization of health care products. Ethylene oxide -- Guidance on the application of ISO 11135-1

PUBLISH DATE 2011
PAGES 48
BSI DD CEN ISO/TS 11135-2:2008

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.

SDO BSI: British Standards Institution
Document Number CISO/TS 11135-2
Publication Date Sept. 30, 2011
Language en - English
Page Count 48
Revision Level
Supercedes
Committee CH/198
Publish Date Document Id Type View
Sept. 30, 2011 DD CEN ISO/TS 11135-2:2008 Consolidated