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ANSI/AAMI/ISO 11137-1:2006 (R2015) and A1:2013

Sterilization of health care products-Radiation-Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices, 2ed and Amendment 1.

Specifies requirements for validation, process control, and routine monitoring in the radiation sterilization for health care products. It applies to continuous and batch type gamma irradiators using the radionuclides 60 Co and 137 Cs, and to irradiators using a beam from an electron or X-ray generator.

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Association for the Advancement of Medical Instrumentation [aami]

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