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ANSI/AAMI/ISO 11137-1:2006 (R2010)/A1:2013

Amendment 1 - Sterilization of health care products - Radiation - Part 1: Requirements for development, validation, and routine control of a sterilization process for medical devices

Amendment 1 to ANSI/AAMI/ISO 11137-1:2006 (R2010). Specifies requirements for validation, process control and routine monitoring in the radiation sterilization for health care products.

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Association for the Advancement of Medical Instrumentation [aami]

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