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.