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IEC 61223-3-8:2024

Evaluation and routine testing in medical imaging departments - Part 3-8: Acceptance and constancy tests - Imaging performance of X-ray equipment for radiography and radioscopy

Edition date: 2024-03-26
In Force
Available languages: English, French
Summary: IEC 61223-3-8:2024 applies to evaluation of the imaging performance and related quality control parameters of X‑ray equipment for radiography and radioscopy that conform to IEC 60601-2-54:2022 or IEC 60601-2-43:2022.
This document applies to the evaluation of the imaging performance of the entire imaging chain from image acquisition, image processing and image display.
This document applies to acceptance tests and constancy tests, which are part of the quality assurance program in medical imaging departments and are intended to be performed by or under the responsibility of the responsible organization. A detailed discussion of the position of these tests within the medical radiological equipment lifecycle is provided in Clause A.2. The methods included rely mainly on non-invasive measurements that use appropriate test equipment and are performed after the installation is completed in accordance with the manufacturer’s installation instructions.
IEC 60601-2-54:2022 and IEC 60601-2-43:2022 require information to be provided to the responsible organization with respect to quality control. This document provides guidance to manufacturers regarding the acceptance and constancy tests for the X‑ray equipment in a manufacturer supplied quality control manual. Annex G provides guidance for such a manual.

L'IEC 61223-3-8:2024 s’applique à l’évaluation des performances et des paramètres de contrôle de la qualité associés d’imagerie des appareils à rayonnement X pour la radiographie et la radioscopie conformes à l’IEC 60601‑2‑54:2022 ou l’IEC 60601-2-43:2022.
Le présent document s’applique à l’évaluation des performances d’imagerie de l’ensemble de la chaîne d’imagerie qui va de l’acquisition de l’image à son affichage, en passant par son traitement.
Le présent document s’applique aux essais d’acceptation et aux essais de constance, qui font partie du programme d’assurance de la qualité dans les services d’imagerie médicale et qui sont destinés à être réalisés par ou sous la responsabilité de l’organisme responsable. L’Article A.2 de l’Annexe A présente une discussion détaillée de la place de ces essais dans le cycle de vie des appareils radiologiques médicaux. Les méthodes incluses reposent principalement sur des mesurages non invasifs, exécutés à l’issue de l’installation, en utilisant des équipements d’essai appropriés conformément aux instructions d’installation du fabricant.
L’IEC 60601-2-54:2022 et l’IEC 60601-2-43:2022 exigent que des informations soient fournies à l’organisme responsable en ce qui concerne le contrôle de la qualité. Le présent document fournit des recommandations aux fabricants en ce qui concerne les essais d’acceptation et de constance pour les appareils à rayonnement X pris en considération dans le manuel de contrôle de la qualité d’un fabricant. L’Annexe G fournit des recommandations pour un tel manuel.
ICS: 11.040.50-Radiographic equipment
CTN: TC 62/SC 62B - 1361

Otras Relaciones

Acuerdo de Frankfurt FprEN IEC 61223-3-8:2023

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