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CAN/CSA-Z11135-2-09 (R2014)

Sterilization of health care products - Ethylene oxide - Part 2: Guidance on the application of ISO 11135-1 (Adopted ISO/TS 11135-2:2008, first edition, 2008-08-01)

SKU: 2419583 Published by CSA Group Publication Year 2009 Reaffirmed in 2014 58 pages Withdrawn

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Preface/Scope

Preface

This is the first edition of CAN/CSA-Z11135-2, Sterilization of health care products - Ethylene oxide - Part 2: Guidance on the application of ISO 11135-1, which is an adoption without modification of the identically titled ISO (International Organization for Standardization) Technical Specification 11135-2 (first edition, 2008-08-01).

Scope

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.

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