AAMI TIR35:2016/(R)2021

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

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AAMI TIR35:2016/(R)2021

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

PUBLISH DATE 2021
AAMI TIR35:2016/(R)2021
This technical information report 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.
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