ISO/TS 13004:2013

Sterilization of health care products — Radiation — Substantiation of selected sterilization dose: Method VDmaxSD ISO/TS 13004:2013

Publication date:   May 6, 2013

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.