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

ISO/TS 13004

Sterilization of health care products — Radiation — Substantiation of selected sterilization dose: Method VDmaxSD

CURRENCY
202.81 €
Označení normy:ISO/TS 13004
Počet stran:57
Vydání:1
Vydáno:2013
Jazyk:Anglicky
DESCRIPTION

ISO/TS 13004


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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