BSI PD CEN ISO/TS 13004:2014

Withdrawn Consolidated
Sterilization of health care products — Radiation — Substantiation of selected sterilization dose: Method VD<sub>max</sub>SD

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A newer publication replaces it: BSI BS EN ISO 13004


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BSI PD CEN ISO/TS 13004:2014

Sterilization of health care products — Radiation — Substantiation of selected sterilization dose: Method VD<sub>max</sub>SD

PUBLISH DATE 2014
PAGES 68
BSI PD CEN ISO/TS 13004:2014

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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