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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

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). Supercedes ANSI/AAMI/ISO TIR 15843:2000.

Content Provider
Association for the Advancement of Medical Instrumentation [aami]

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