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:Sterilization of health care products