Withdrawn
ISO 11137-2:2011 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. ISO 11137-2:2011 also specifies methods of sterilization dose audit used to demonstrate the continued effectiveness of the sterilization dose.
ISO 11137-2:2011 defines product families for sterilization dose establishment and sterilization dose audit.
Directives related to this standards.
WITHDRAWN
SSH EN ISO 11137-2:2012
95.99
Withdrawal of Standard
May 6, 2014
WITHDRAWN
SSH EN ISO 11137-2:2013