Sterilization of health care products. Ethylene oxide -- 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 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 | |
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| Supercedes | |
| Committee | CH/198 |
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