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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
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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.
SDO BSI: British Standards Institution
Document Number CISO/TS 13004
Publication Date July 31, 2014
Language en - English
Page Count
Revision Level
Supercedes
Committee CH/198
Publish Date Document Id Type View
July 31, 2014 PD CEN ISO/TS 13004:2014 Consolidated