ISO/TS 13004:2013 PDF Download
Standard EN Sample
Sterilization of health care products — Radiation — Substantiation of selected sterilization dose: Method VDmaxSD
Also Known As:
SKU145396932
Published by
International Organization for Standardization
ISO
Publication Date2013-05
Pages CountPages64
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.
Details
| Edition | 1 |
| ICS Codes | 11.080.01 - Sterilization and disinfection in general |
| Language(s) | English |
| File Size | 481.3 KB |
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