DS/CEN ISO/TS 11135-2
Sterilization of health care products - Ethylene oxide - Part 2: Guidance on the application of ISO 11135-1 (ISO/TS 11135-2:2008)
| Organization: | DS |
| Status: | inactive |
| Page Count: | 50 |
| 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.
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