Describes methods that can be used to determine the minimum dose necessary to achieve the specified requirement for sterility, including methods to substantiate 25 kGy as the sterilization dose.
ANSI/AAMI/ISO 11137-2:2012 history
2013ANSI/AAMI/ISO 11137-2:2013 Sterilization of health care products.Radiation .Part 2: Establishing the sterilization dose
2012ANSI/AAMI/ISO 11137-2:2012 Sterilization of health care products.Radiation .Part 2: Establishing the sterilization dose