PDF Standards AAMI TIR35:2016 (R2021)

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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:

06/04/2016

ISBN(s):

157020618X

File Size:

1 file , 720 KB

Note:

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