Historical
AAMI/ISO TIR 13409:1996
Sterilization of health care products - Radiation sterilization - Substantiation of 25 kGy as a sterilization dose for small or infrequent production batches
Describes a method of substantiating the suitability of 25 kGy as a sterilization dose for radiation sterilization of products with an average bioburden of less than 1,000 colony forming units (cfu) that are manufactured in small quantities (less than 1,000 product units).
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Association for the Advancement of Medical Instrumentation [aami]