ISO 11137-2:2006
Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose
- Standard No.
- ISO 11137-2:2006
- Release Date
- 2006
- Published By
- International Organization for Standardization (ISO)
- Status
- Replace By
- ISO 11137-2:2006/Cor 1:2009
- Latest
- ISO 11137-2:2013/Amd 1:2022
- Scope
- This part of ISO 11137 specifies methods of determining the minimum dose needed to achieve a specified requirement for sterility and methods to substantiate the use of 25 kGy or 15 kGy as the sterilization dose to achieve a sterility assurance level, SAL, of 10–6. This part of ISO 11137 also specifies methods of dose auditing in order to demonstrate the continued effectiveness of the sterilization dose. This part of ISO 11137 defines product families for dose establishment and dose auditing.
ISO 11137-2:2006 history
- 2022 ISO 11137-2:2013/Amd 1:2022 Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose — Amendment 1
- 2013 ISO 11137-2:2013 Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose
- 2012 ISO 11137-2:2012 Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose
- 2009 ISO 11137-2:2006/Cor 1:2009 Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose; Technical Corrigendum 1
- 2006 ISO 11137-2:2006 Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose
