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<p>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<sup>−6</sup>. ISO 11137-2:2013 also specifies methods of sterilization dose audit used to demonstrate the continued effectiveness of the sterilization dose.</p>
<p>ISO 11137-2:2013 defines product families for sterilization dose establishment and sterilization dose audit.</p>
Reģistrācijas numurs (WIID)
90093
Darbības sfēra
<p>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<sup>−6</sup>. ISO 11137-2:2013 also specifies methods of sterilization dose audit used to demonstrate the continued effectiveness of the sterilization dose.</p>
<p>ISO 11137-2:2013 defines product families for sterilization dose establishment and sterilization dose audit.</p>
