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ISO/TS 13004:2013

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

General information

Withdrawn from 07.10.2022
Directives or regulations
None

Standard history

Status
Date
Type
Name
07.10.2022
Main
06.05.2013
Main
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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