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IEC 61223-3-8:2024

(Main)

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

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

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.

Essais d'évaluation et de routine dans les services d'imagerie médicale - Partie 3-8: Essais d'acceptation et de constance - Performance d'imagerie des appareils à rayonnement X pour la radiographie et la radioscopie

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.

General Information

Status
Published
Publication Date
25-Mar-2024
ICS
11.040.50 - Radiographic equipment
Technical Committee
SC 62B - Medical imaging equipment, software, and systems
Drafting Committee
WG 37 - TC 62/SC 62B/WG 37
Current Stage
PPUB - Publication issued
Start Date
12-Apr-2024
Completion Date
26-Mar-2024
Ref Project

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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 Released:3/26/2024 Isbn:9782832285657IEC 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 Released:3/26/2024 Isbn:9782832285657
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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 Released:3/26/2024 Isbn:9782832285657
English and French language
199 pages
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IEC 61223-3-8 ®
Edition 1.0 2024-03
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
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

Essais d'évaluation et de routine dans les services d'imagerie médicale –
Partie 3-8: Essais d'acceptation et de constance – Performance d'imagerie des
appareils à rayonnement X pour la radiographie et la radioscopie
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form
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IEC 61223-3-8 ®
Edition 1.0 2024-03
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
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

Essais d'évaluation et de routine dans les services d'imagerie médicale –

Partie 3-8: Essais d'acceptation et de constance – Performance d'imagerie des

appareils à rayonnement X pour la radiographie et la radioscopie

INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 11.040.50  ISBN 978-2-8322-8565-7

– 2 – IEC 61223-3-8:2024 © IEC 2024
CONTENTS
FOREWORD . 8
INTRODUCTION . 10
1 Scope and object . 11
2 Normative references . 11
3 Terms, definitions, symbols and abbreviated terms . 12
3.1 Terms and definitions . 12
3.2 Symbols and abbreviated terms . 21
4 General aspects of ACCEPTANCE TESTING . 21
4.1 General . 21
4.2 Levels of requirements . 22
4.2.1 General . 22
4.2.2 Local regulatory requirements . 22
4.2.3 Contractual requirements . 22
4.2.4 MANUFACTURER specifications . 22
4.3 General conditions in test procedures . 22
4.4 Documents and data for the tests . 22
4.5 Test conditions . 23
4.6 Scope of tests . 25
4.7 Test equipment including PHANTOMS and TEST DEVICES . 26
4.7.1 General . 26
4.7.2 Analysis software. 26
4.7.3 Viewing conditions . 26
4.7.4 High-voltage measuring instrument . 26
4.7.5 DOSIMETER . 26
4.7.6 PHANTOMS, TEST DEVICES and their application . 26
4.8 Evaluating the test results . 29
5 Specific aspects of CONSTANCY TESTING . 29
5.1 General . 29
5.2 Establishment of BASELINE VALUES . 29
5.3 CONSTANCY TESTING and SIMPLE CHECKS . 30
5.4 Frequency of CONSTANCY TESTS . 30
6 Summary of tests for X‑RAY EQUIPMENT . 30
7 Requirements and test methods . 32
7.1 General . 32
7.2 Functional properties . 33
7.2.1 Test requirements . 33
7.2.2 Test method for ACCEPTANCE TEST . 33
7.2.3 Test method for CONSTANCY TEST . 33
7.3 IMAGE DISPLAY DEVICE performance . 33
7.3.1 Test requirements . 33
7.3.2 Test method for ACCEPTANCE TEST . 33
7.3.3 Test method for CONSTANCY TEST . 34
7.4 X‑RAY TUBE VOLTAGE . 34
7.4.1 Test requirements . 34
7.4.2 Test method for ACCEPTANCE TEST . 34
7.4.3 Test method for CONSTANCY TEST . 35

7.5 X‑RAY TUBE CURRENT or CURRENT TIME PRODUCT . 35
7.5.1 Test requirements . 35
7.5.2 Test method for ACCEPTANCE TEST . 35
7.5.3 Test method for CONSTANCY TEST . 35
7.6 HALF-VALUE LAYER of the X‑RAY SOURCE ASSEMBLY . 35
7.6.1 Test requirements . 35
7.6.2 Test method for ACCEPTANCE TEST . 36
7.6.3 Test method for CONSTANCY TEST . 36
7.7 * QUALITY EQUIVALENT FILTRATION of ADDED FILTERS . 36
7.7.1 Test requirements . 36
7.7.2 * Test method for ACCEPTANCE TEST . 36
7.7.3 Test method for CONSTANCY TEST . 36
7.8 * ATTENUATION EQUIVALENT of materials between the PATIENT and the X‑RAY
IMAGE RECEPTOR . 36
7.8.1 Test requirements . 36
7.8.2 * Test method for ACCEPTANCE TEST . 37
7.8.3 Test method for CONSTANCY TEST . 37
7.9 FOCAL SPOT of the X‑RAY TUBE . 37
7.9.1 Test requirements . 37
7.9.2 Test method for ACCEPTANCE TEST . 37
7.9.3 Test method for CONSTANCY TEST . 37
7.10 Assessing geometrical properties of the X-RAY EQUIPMENT . 37
7.10.1 Test requirements . 37
7.10.2 Test method for ACCEPTANCE TEST . 37
7.10.3 Test method for CONSTANCY TEST . 37
7.11 AUTOMATIC CONTROL SYSTEM ─ Performance . 38
7.11.1 Tes
...

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