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CEN ISO/TS 13004:2014

Sterilization of health care products - Radiation - Substantiation of selected sterilization dose: Method VDmaxSD (ISO/TS 13004:2013) CEN ISO/TS 13004:2014

Publication date:   Jul 17, 2014

General information

99.60 Withdrawal effective   Jun 28, 2023

CEN

CEN/TC 204 Sterilization of medical devices

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WITHDRAWN
CEN ISO/TS 13004:2014
99.60 Withdrawal effective
Jun 28, 2023

REVISED BY

PUBLISHED
EN ISO 13004:2023

Relations

Adopted from ISO/TS 13004:2013 IDENTICAL