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ANSI/AAMI/ISO TIR13004:2013 (R2016)

Sterilization of health care products - Radiation - Substantiation of a selected sterilization dose: Method VDmaxSD

This Technical Specification describes a method for substantiating a selected sterilization dose of 17.5, 20, 22.5, 27.5, 30, 32.5 or 35 kGy that achieves a sterility assurance level (SAL) of 10-6 or less for radiation sterilization of health care products. This Technical Specification also specifies a method of sterilization dose audit used to demonstrate the continued effectiveness of the substantiated sterilization dose.

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Association for the Advancement of Medical Instrumentation [aami]

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