ÖNORM EN ISO 13004:2023 11 01
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Sterilization of health care products - Radiation - Substantiation of selected sterilization dose: Method VDmax SD (ISO 13004:2022
Available format(s)
Hardcopy
Language(s)
German - English
Published date
01-11-2023
This document describes a method for substantiating a selected sterilization dose of 17,5 kGy, 20 kGy, 22,5 kGy, 27,5 kGy, 30 kGy, 32,5 kGy or 35 kGy that achieves a sterility assurance level (SAL) of 10^(-6) or less for radiation sterilization of health care products.
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