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EN ISO 13004:2023

Sterilization of health care products - Radiation - Substantiation of selected sterilization dose: Method VDmaxSD (ISO 13004:2022) EN ISO 13004:2023

Publication date:   Oct 16, 2023

General information

60.60 Standard published   Jun 28, 2023

CEN

CEN/TC 204 Sterilization of medical devices

European Norm

11.080.01   Sterilization and disinfection in general

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Scope

Adoption of ISO 13004:2022 – This is currently in FDIS and will be publishing in October 2022.

This document 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. This Technical Specification also specifies a method of sterilization
dose audit used to demonstrate the continued effectiveness of the substantiated sterilization dose.

NOTE Selection and substantiation of the sterilization dose is used to meet the requirements for establishing
the sterilization dose within process definition in ISO 11137-1.

Life cycle

PREVIOUSLY

WITHDRAWN
CEN ISO/TS 13004:2014

NOW

PUBLISHED
EN ISO 13004:2023
60.60 Standard published
Jun 28, 2023

Relations

Adopted from ISO 13004:2022 IDENTICAL