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AAMI TIR35

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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Organization: AAMI
Publication Date: 1 January 2016
Status: active
Page Count: 36
scope:

This TIR 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. Additionally, guidance for adopting a product into an existing product family and maintenance of product families is provided.

Document History

AAMI TIR35
January 1, 2016
Sterilization of health care products- Radiation sterilization- Product adoption and alternative sampling plans for verification dose experiments and sterilization dose audits
This TIR 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...
January 1, 2006
Sterilization of health care products - Radiation sterilization - Alternative sampling plans for verification dose experiments and sterilization dose audits
This TIR describes approaches to the selection and auditing of a sterilization dose that may reduce the number of product units required while maintaining assurance of attaining the desired sterility...

References

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