Sterilization of health care products Radiation Part 2: Establishing the sterilization dose
|Publication Date:||15 April 2006|
|ICS Code (Sterilization and disinfection in general):||11.080.01|
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.