AAMI TIR35:2006

Sterilization of health care products - Radiation sterilization - Alternative sampling plans for verification dose experiments and sterilization dose audits

Association for the Advancement of Medical Instrumentation , 01/16/2007

Publisher: AAMI

File Format: PDF

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Description

Standard By:Association for the Advancement of Medical Instrumentation , 01/16/2007

Published:01/16/2007

Pages:25

ISBN(s):1570202788

File Size:1 file , 170 KB

Language:English

Note:This product is unavailable in Belarus, Russia, Ukraine

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.