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DIN EN ISO 13004:2023
Sterilization of health care products - Radiation - Substantiation of selected sterilization dose: Method VD<(Index)max><(hoch)SD> (ISO 13004:2022); German version EN ISO 13004:2023
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. This document also specifies a method of sterilization dose audit used to demonstrate the continued effectiveness of the substantiated sterilization dose. The responsible national standards body is the working committee NA 176-03-09 AA "Sterilization and reprocessing of medical devices" in the DIN Standards Committee on Health Technologies (NAGesuTech). This document is the adoption of a published ISO standard for the development of Annex ZA for conformity to the Medical Devices Regulation.
Deutsches Institut für Normung [din]