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

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

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

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

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