GSO ISO/TS 13004:2021
ISO/TS 13004:2013
Gulf Standard
Current Edition
·
Approved on
01 July 2021
Sterilization of health care products — Radiation — Substantiation of selected sterilization dose: Method VDmaxSD
GSO ISO/TS 13004:2021 Files
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GSO ISO/TS 13004:2021 Scope
ISO/TS 13004:2013 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. ISO/TS 13004:2013 also specifies a method of sterilization dose audit used to demonstrate the continued effectiveness of the substantiated sterilization dose.
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