Name: SS-EN ISO 13004:2023 - Sterilization of health care products - Radiation - Substantiation of selected sterilization dose: Method VDmaxSD (ISO 13004:2022)
Brand: Standardiserings-Kommissionen I Sverige

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Sterilization of health care products - Radiation - Substantiation of selected sterilization dose: Method VDmaxSD (ISO 13004:2022)

Published date

04-07-2023

Publisher

Standardiserings-Kommissionen I Sverige

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This document describes a method for substantiating a selected sterilization dose of 17,5, 20, 22,5, 27,5, 30, 32,5 or 35 kGy that achieves a sterility assurance level (SAL) of 10-6 or less for radiation sterilization of health care products.