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ANSI/AAMI/ISO TIR13004:2013/(R)2016 [HISTORICAL]
Sterilization of health care products - Radiation - Substantiation of a selected sterilization dose: Method VDmaxSD
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Summary
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. Annex 3
Technical characteristics
| Publisher | Association for the Advancement of Medical Instrumentation (AAMI) |
| Publication Date | 01/01/2013 |
| Confirmation Date | 01/01/2016 |
| Page Count | 0 |
| Themes | Sterilization—Industrial |
| EAN | --- |
| ISBN | --- |
| Weight (in grams) | --- |
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Previous versions
01/01/2013
Superseded
, Confirmed
Historical