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Technische Regel
ONR CEN ISO/TS 13004
Issue date: 2014 10 01
Sterilization of health care products - Radiation - Substantiation of selected sterilization dose: Method VDmaxSD (ISO/TS 13004:2013)
This Technical Specification 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 ass...
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Withdrawn
: 2023 11 01
Publisher:
Austrian Standards International
Format:
Digital | 69 Pages
Language:
German
| English
| Download GER/ENG
Currently valid:
Optionally co-design standards:
ICS
This Technical Specification 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. This Technical Specification also specifies a method of sterilization dose audit used to demonstrate the continued effectiveness of the substantiated sterilization dose.
ÖNORM EN ISO 13004
2023 11 01
Sterilization of health care products - Radiation - Substantiation of selected sterilization dose: M...
Norm
ONR CEN ISO/TS 13004
2014 10 01
Sterilization of health care products - Radiation - Substantiation of selected sterilization dose: M...
Technische Regel
↖
ONR CEN ISO/TS 13004
2014 04 01
Sterilization of health care products - Radiation - Substantiation of selected sterilization dose: M...
Technische Regel Entwurf
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ISO 11737-2:2019
Issue date :
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Sterilization of health care products — Microbiological methods — Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
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ÖNORM EN ISO 13004
Issue date :
2023 11 01
Sterilization of health care products - Radiation - Substantiation of selected sterilization dose: Method VDmaxSD (ISO 13004:2022)
Technische Regel
ISO/TS 13004:2013
Issue date :
2013 05 06
Sterilization of health care products — Radiation — Substantiation of selected sterilization dose: Method VDmaxSD