Superseded
Standard
Historical
CEN ISO/TS 13004:2014
Sterilization of health care products - Radiation - Substantiation of selected sterilization dose: Method VDmaxSD (ISO/TS 13004:2013)
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Summary
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.
Technical characteristics
| Publisher | Bureau de Normalisation Belge (NBN) |
| Publication Date | 05/01/2014 |
| Cancellation Date | 06/28/2023 |
| Page Count | 67 |
| EAN | --- |
| ISBN | --- |
| Weight (in grams) | --- |
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