ÖNORM EN ISO 11137-2:2023 10 01
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Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose (ISO 11137-2:2013)
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German - English
01-10-2023
This part of ISO 11137 specifies methods for 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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