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CSA - CAN/CSA-Z11135-2-09

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

inactive
Organization: CSA
Publication Date: 1 March 2009
Status: inactive
Page Count: 58
ICS Code (Sterilization and disinfection in general): 11.080.01
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.

Document History

CAN/CSA-Z11135-2-09
March 1, 2009
Sterilization of health care products - Ethylene oxide - Part 2: Guidance on the application of ISO 11135-1
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...
January 1, 2009
Sterilization of health care products - Ethylene oxide - Part 2: Guidance on the application of ISO 11135-1
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...

References

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