Publikuar
ISO 11137-2:2013 specifies methods for 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. ISO 11137-2:2013 also specifies methods of sterilization dose audit used to demonstrate the continued effectiveness of the sterilization dose.
ISO 11137-2:2013 defines product families for sterilization dose establishment and sterilization dose audit.
Directives related to this standards.
WITHDRAWN
SSH EN ISO 11137-2:2013
PUBLISHED
SSH EN ISO 11137-2:2015
60.60
Standard published
29 mar 2016