ANSI/AAMI/ISO 11137-1:2006

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

AAMI/ISO 11137-1 specifies requirements for validation, process control and routine monitoring in the radiation sterilization for health care products. Supercedes ANSI/AAMI/ISO TIR 15843:2000.

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Association for the Advancement of Medical Instrumentation [aami]

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

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ANSI/AAMI/ISO 11137-1:2006

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

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