AAMI Products
ANSI/AAMI/ISO 11137-1:2006/(R)2015 & A1:2013 & A2:2019 (PDF)
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This document 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.
Date of Publication: 1 May 2019
Pages: 54
ISBN: 1–57020–253–2