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AAMI TIR35:2016

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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Publication date: 2016-06-05
Price: 200 vnd

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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.
Document identifier
AAMI TIR35:2016
Title
Sterilization of health care products - Radiation sterilization - Product adoption and alternative sampling plans for verification dose experiments and sterilization dose audits
AAMI Category
Diagnostic and Monitoring, General and Miscellaneous
Publication date
2016-06-05
Status
Effective
International Relationship
Cross references
Latest version
AAMI TIR35:2016
Sterilization of health care products - Radiation sterilization - Product adoption and alternative sampling plans for verification dose experiments and sterilization dose audits
Document identifier AAMI TIR35:2016
Publication date 2016-06-05
Classification
Status Effective
*
History of version
AAMI TIR35:2016 * AAMI TIR35:2006 * AAMI TIR 15843
Keywords
Classification
Pages
Price 200 vnd