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AAMI TIR35:2016 (R2021)

Sterilization of health care products - Radiation sterilization - Product adoption and alternative sampling plans for verification dose experiments and sterilization dose audits

standard by Association for the Advancement of Medical Instrumentation , 06/04/2016

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Full Description

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 , 700 KB
Note:
This product is unavailable in Russia, Ukraine, Belarus
 

Document History

  1. AAMI TIR35:2016 (R2021)

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    Sterilization of health care products - Radiation sterilization - Product adoption and alternative sampling plans for verification dose experiments and sterilization dose audits

    • Most Recent

  2. AAMI TIR35:2006


    Sterilization of health care products - Radiation sterilization - Alternative sampling plans for verification dose experiments and sterilization dose audits

    • Historical Version

  3. AAMI TIR 15843


    Sterilization of health care products-Radiation sterilization-Product families, sampling plans for verification dose experiments and sterilization dose audits, and frequency of sterilization dose audits

    • Historical Version