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 sterilization assurance level, SAL, of a log of minus six. It also specifies methods of dose auditing in order to demonstrate the continued effectiveness of the sterilization dose.
SANS 11137-2:2007 history
2007SANS 11137-2:2007 Sterilization of health care products - Radiation Part 2: Establishing the sterilization dose