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SRPS CEN ISO/TS 13004:2015

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

Jun 22, 2015
95.99   Withdrawal of Standard   Oct 31, 2023

General information

95.99     Oct 31, 2023

ISS

Z076

Technical Specification

11.080.01  

English  

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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WITHDRAWN
SRPS CEN ISO/TS 13004:2015
95.99 Withdrawal of Standard
Oct 31, 2023

REVISED BY

PUBLISHED
SRPS EN ISO 13004:2023

Related project

Adopted from CEN ISO/TS 13004:2014

Adopted from ISO/TS 13004:2013 IDENTICAL