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Technische Regel
ISO/TS 13004:2013
Issue date: 2013 05 06
Sterilization of health care products — Radiation — Substantiation of selected sterilization dose: Method VDmaxSD
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 leve...
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Withdrawn
: 2022 10 07
Publisher:
International Organization for Standardization
Format:
Digital | 57 Pages
Language:
English
Currently valid:
ICS
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.
ISO 13004:2022
2022 10 07
Sterilization of health care products — Radiation — Substantiation of selected sterilization dose: M...
Norm
ISO/TS 13004:2013
2013 05 06
Sterilization of health care products — Radiation — Substantiation of selected sterilization dose: M...
Technische Regel
↖
Norm
ISO 13004:2022
Issue date :
2022 10 07
Sterilization of health care products — Radiation — Substantiation of selected sterilization dose: Method VDmaxSD