Sterilization of health care products — Radiation — Substantiation of selected sterilization dose: Method VDmaxSD
Sterilization of health care products — Radiation — Substantiation of selected sterilization dose: Method VDmaxSD
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What is ISO/TS 13004 - VDmaxSD for substantiation of selected sterilization dose about?
ISO/TS 13004 is a European standard that discusses the sterilization of health care products. ISO/TS 13004 outlines 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 outlines a method of sterilization dose audit used to demonstrate the continued effectiveness of the substantiated sterilization dose. Note: Selection and substantiation of the sterilization dose are used to meet the requirements for establishing the sterilization dose within process definition in ISO 11137-1 .
Who is ISO/TS 13004 - VDmaxSD for substantiation of selected sterilization dose for?
ISO/TS 13004 o...
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