ISO 11137-2:2006 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. It also specifies methods of dose auditing in order to demonstrate the continued effectiveness of the sterilization dose.
ISO 11137-2:2006 defines product families for dose establishment and dose auditing.
Status: WithdrawnPublication date: 2006-04
Corrected version (en): 2006-07
Corrected version (fr): 2006-07
Edition: 1Number of pages: 60
Technical Committee: ISO/TC 198 Sterilization of health care products