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Full Description

Describes approaches to the selection and auditing of a sterilization dose that economize in relation to the number of product units 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.
 

Document History

  1. 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

    • Most Recent
  2. AAMI TIR35:2006

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    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