EVS-EN ISO 11137-2:2015

ISO 11137-2 specifies methods for determining the minimum dose needed to achieve a specified requirement for sterility. It also provides 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.

ISO 11137-2 describes methods of sterilization dose audit used to demonstrate the continued effectiveness of the sterilization dose. This standard defines product families for sterilization dose establishment and sterilization dose audit.

The text of ISO 11135:2014 has been approved in Europe as EN ISO 11137-2:2015 without any changes.