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AAMI TIR76:2021

Sterilization of health care products - Radiation - Substantiation of a selected sterilization dose at a specified sterility assurance level: Method Vdmax SD-S

This technical information report describes a method for substantiating a selected sterilization dose that achieves maximally a selected sterility assurance level (SAL) for radiation sterilization of healthcare products and 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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