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ISO/TS 13004:2013

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

Publication date:   May 6, 2013

95.99   Withdrawal of Standard   Oct 7, 2022

General information

95.99   Withdrawal of Standard   Oct 7, 2022

ISO

ISO/TC 198 Sterilization of health care products

Technical Specification

11.080.01   Sterilization and disinfection in general

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Scope

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.

Life cycle

NOW

WITHDRAWN
ISO/TS 13004:2013
95.99 Withdrawal of Standard
Oct 7, 2022

REVISED BY

PUBLISHED
ISO 13004:2022