<p>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<sup>-6</sup>. It also specifies methods of dose auditing in order to demonstrate the continued effectiveness of the sterilization dose.</p>
<p>ISO 11137-2:2006 defines product families for dose establishment and dose auditing.</p>
Registration number (WIID)
33953
Scope
<p>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<sup>-6</sup>. It also specifies methods of dose auditing in order to demonstrate the continued effectiveness of the sterilization dose.</p>
<p>ISO 11137-2:2006 defines product families for dose establishment and dose auditing.</p>
