DS CEN ISO/TS 13004:2014现行
Sterilization Of Health Care Products - Radiation - Substantiation Of Selected Sterilization Dose: Method Vd[Max][Sd]
出版：Danish Standards
专家解读视频
Explains 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. Also specifies a method of sterilization dose audit used to demonstrate the continued effectiveness of the substantiated sterilization dose.
CEN ISO/TS 13004:2014 - Identical
ISO TS 13004 : 2013(R2017) - Identical
ISO TS 13004 : 2013(R2017) - Identical
CEN ISO/TS 13004 : 2014 - Identical
