This standard has been revised by ISO 13004:2022
Abstract
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.
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Status: WithdrawnPublication date: 2013-05
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Edition: 1Number of pages: 57
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- ICS :
- 11.080.01 Sterilization and disinfection in general
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