<p>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<sup>-6</sup>. ISO 11137-2:2011 also specifies methods of sterilization dose audit used to demonstrate the continued effectiveness of the sterilization dose.</p>
<p>ISO 11137-2:2011 defines product families for sterilization dose establishment and sterilization dose audit.</p>
Registration number (WIID)
51238
Scope
<p>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<sup>-6</sup>. ISO 11137-2:2011 also specifies methods of sterilization dose audit used to demonstrate the continued effectiveness of the sterilization dose.</p>
<p>ISO 11137-2:2011 defines product families for sterilization dose establishment and sterilization dose audit.</p>
