ISO/TS 11135-2:2008
Sterilization of health care products - Ethylene oxide - Part 2: Guidance on the application of ISO 11135-1
- Standard No.
- ISO/TS 11135-2:2008
- Release Date
- 2008
- Published By
- International Organization for Standardization (ISO)
- Status
- Replace By
- ISO/TS 11135-2:2008/Cor 1:2009
- Latest
- ISO/TS 11135-2:2008/Cor 1:2009
- 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.
ISO/TS 11135-2:2008 history
- 2009 ISO/TS 11135-2:2008/Cor 1:2009 Sterilization of health care products - Ethylene oxide - Part 2: Guidance on the application of ISO 11135-1; Technical Corrigendum 1
- 2008 ISO/TS 11135-2:2008 Sterilization of health care products - Ethylene oxide - Part 2: Guidance on the application of ISO 11135-1
