AAMI TIR35:2016

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Describes approaches to the selection and auditing of a sterilization dose that may reduce the number of product items required while maintaining assurance of attaining the desired sterility assurance level (SAL). This approach addresses sampling plans for verification dose experiments and sterilization dose audits. In addition the approaches to adopting a product into an established product family are defined.

Product Details

Published:
06/05/2016
ISBN(s):
157020618X
File Size:
1 file , 640 KB

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