DS/EN ISO 11137-2:2015/A1:2023
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Sterilization of health care products – Radiation – Part 2: Establishing the sterilization dose – Amendment 1
Amendment of
Published date
04-25-2023
Publisher
This part of ISO 11137 specifies methods of determining the minimum dose needed to achieve a specified requirement for sterility and methods to substantiate the use of 25 kGy or 15 kGy as the sterilization dose to achieve a sterility assurance level, SAL, of 10–6.
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