ISO-13004 Sterilization of health care products - Radiation - Substantiation of selected sterilization dose: Method VDmaxSD

ISO-13004 - 1ST EDITION - CURRENT


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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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11.080.01 (Sterilization and disinfection in general Including sterilization methods, air quality of surgery rooms, etc.)

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Document Number

ISO/TS 13004:2013

Revision Level

1ST EDITION

Status

Current

Publication Date

May 1, 2013

Committee Number

ISO/TC 198