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ANSI/AAMI/ISO 11137-1:2006 (R2015) and A1:2013 and A2:2019

(Consolidated Text)

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. Consolidation of standard and amendments 1 and 2.

Association for the Advancement of Medical Instrumentation [aami]

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