AAMI ANSI/AAMI/ISO 11137-1:2006/(R)2015 & A1:2013 & A2:2019

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

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AAMI ANSI/AAMI/ISO 11137-1:2006/(R)2015 & A1:2013 & A2:2019

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

PUBLISH DATE 2019
AAMI ANSI/AAMI/ISO 11137-1:2006/(R)2015 & A1:2013 & A2:2019
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.
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