BAS CEN ISO/TS 13004:2015
Sterilization of health care products - Radiation - Substantiation of selected sterilization dose: Method VDmaxSD
General Information
Status: Published
No. of pages: 60
Language: English
Edition: 1.
Adoption method: Endorsment
Publication date: 10.06.2015
Technical committee:
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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.
Lifecycle
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Original document and degree of correspondence
- CEN ISO/TS 13004:2014, identical
- ISO/TS 13004:2013, identical