This part of ISO 11137 specifies methods for determining the minimum dose needed to achieve a specifiedrequirement for sterility and methods to substantiate the use of 25 kGy or 15 kGy as the sterilization dose toachieve a sterility assurance level, SAL, of 10–6.This part of ISO 11137 also specifies methods of sterilizationdose audit used to demonstrate the continued effectiveness of the sterilization dose.
EN ISO 11137-2:2012 history
2023EN ISO 11137-2:2015/A1:2023 Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose - Amendment 1 (ISO 11137-2:2013/Amd 1:2022)
2021EN ISO 11137-2:2015/prA1:2021 Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose - Amendment 1 (ISO 11137-2:2013/DAmd 1:2021)
2015EN ISO 11137-2:2015 Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose
2013EN ISO 11137-2:2013 Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose
2012EN ISO 11137-2:2012 Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose
2007EN ISO 11137-2:2007 Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose