ANSI/AAMI/ISO 11137-2:2013/(R)2019
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ANSI/AAMI/ISO 11137-2:2013/(R)2019

Sterilization of health care products—Radiation—Part 2: Establishing the sterilization dose

Summary

This document describes methods that can be used to determine the minimum dose necessary to achieve the specified requirement for sterility, including methods to substantiate 25 kGy as the sterilization dose. This 2013 edition incorporates minor revisions, which are noted in the ISO foreword. It was reaffirmed in 2019. Annex 2

Technical characteristics

Publisher Association for the Advancement of Medical Instrumentation (AAMI)
Publication Date 01/01/2013
Confirmation Date 01/01/2019
Page Count 0
Themes Sterilization—Industrial
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