
Sterilization of Health Care Products - Radiation - Substantiation of Selected Sterilization Dose: Method Vd[max][sd] (iso/ts 13004:2013)
出版:National Standards Authority of Ireland

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Defines 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.
CEN ISO/TS 13004 : 2014 - Identical
ISO TS 13004 : 2013(R2017) - Identical
ISO TS 13004 : 2013(R2017) - Identical