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DS/EN ISO 13004:2023
Sterilization of health care products - Radiation - Substantiation of selected sterilization dose: Method VDmaxSD (ISO 13004:2022)
Adoption of ISO 13004:2022 – This is currently in FDIS and will be publishing in October 2022. ****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. This Technical Specification also specifies a method of sterilization**dose audit used to demonstrate the continued effectiveness of the substantiated sterilization dose.****NOTE – Selection and substantiation of the sterilization dose is used to meet the requirements for establishing**the sterilization dose within process definition in ISO 11137-1.
Danish Standards [ds]