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.
AAMI/ISO 11137-2:2006 history
2012AAMI/ISO 11137-2:2012 Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose
2009AAMI/ISO 11137-2:2006 Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (Corrected 21 April 2009)