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AAMI TIR35:2006

M00002729

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AAMI TIR35:2006 Sterilization of health care products - Radiation sterilization - Alternative sampling plans for verification dose experiments and sterilization dose audits

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

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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.