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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
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Assoc. for the Advancement of Medical Instrumentation Logo

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.
SDO AAMI: Assoc. for the Advancement of Medical Instrumentation
Document Number TIR35
Publication Date Sept. 9, 2021
Language en - English
Page Count 36
Revision Level
Supercedes
Committee
Publish Date Document Id Type View
Sept. 9, 2021 Revision