DS/EN ISO 13004:2023
Current
Current
The latest, up-to-date edition.
Sterilization of health care products– Radiation– Substantiation of selected sterilization dose: Method VDmaxSD (ISO 13004:2022)
Published date
04-07-2023
Publisher
This document describes a method for substantiating a selected sterilization dose of 17,5kGy, 20kGy, 22,5kGy, 27,5kGy, 30kGy, 32,5kGy or 35kGy that achieves a sterility assurance level (SAL) of 10−6or less for radiation sterilization of health care products.
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