CSA 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.
| Edition : | 1st |
| File Size : | 1
file
, 1.1 MB |
| ISBN(s) : | 9781554910793 |
| Note : | This product is unavailable in Russia, Ukraine, Belarus |
| Number of Pages : | 58 |
| Product Code(s) : | 2419584, 2419584, 2419583 |
| Published : | 03/01/2009 |
