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DS CEN ISO/TS 13004:2014

Sterilization of health care products - Radiation - Substantiation of selected sterilization dose: Method VDmaxSD (ISO/TS 13004:2013)

Nov 27, 2015
95.99 Withdrawal of Standard   Apr 8, 2025

General information

95.99     Apr 8, 2025

DPS

DPS/KT 316

Technical Specification

11.080.01  

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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WITHDRAWN
DS CEN ISO/TS 13004:2014
95.99 Withdrawal of Standard
Apr 8, 2025

REVISED BY

PUBLISHED
SSH EN ISO 13004:2023

Related project

Adopted from CEN ISO/TS 13004:2014