EN 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.
Bewertung und routinemäßige Prüfung in Abteilungen für medizinische Bildgebung - Teil 3-8: Abnahme- und Konstanzprüfungen - Leistungsmerkmale zur Bildgebung von Röntgeneinrichtungen für Radiographie und Radioskopie
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.
Vrednotenje in rutinsko preskušanje v medicinskih oddelkih za slikanje - 3-8. del: Preskusi sprejemljivosti in konstantnosti - Slikovni učinek rentgenske opreme za radiografijo in radioskopijo (IEC 61223-3-8:2024)
General Information
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN IEC 61223-3-8:2024
01-julij-2024
Vrednotenje in rutinsko preskušanje v medicinskih oddelkih za slikanje - 3-8. del:
Preskusi sprejemljivosti in konstantnosti - Slikovni učinek rentgenske opreme za
radiografijo in radioskopijo (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 (IEC 61223-3-8:2024)
Bewertung und routinemäßige Prüfung in Abteilungen für medizinische Bildgebung - Teil
3-8: Abnahme- und Konstanzprüfungen - Leistungsmerkmale zur Bildgebung von
Röntgeneinrichtungen für Radiographie und Radioskopie (IEC 61223-3-8:2024)
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 (IEC 61223-3-8:2024)
Ta slovenski standard je istoveten z: EN IEC 61223-3-8:2024
ICS:
11.040.50 Radiografska oprema Radiographic equipment
SIST EN IEC 61223-3-8:2024 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN IEC 61223-3-8:2024
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SIST EN IEC 61223-3-8:2024
EUROPEAN STANDARD EN IEC 61223-3-8
NORME EUROPÉENNE
EUROPÄISCHE NORM May 2024
ICS 11.040.50
English Version
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)
Essais d'évaluation et de routine dans les services Bewertung und routinemäßige Prüfung in Abteilungen für
d'imagerie médicale - Partie 3-8: Essais d'acceptation et de medizinische Bildgebung - Teil 3-8: Abnahme- und
constance - Performance d'imagerie des appareils à Konstanzprüfungen - Leistungsmerkmale zur Bildgebung
rayonnement X pour la radiographie et la radioscopie von Röntgeneinrichtungen für Radiographie und
(IEC 61223-3-8:2024) Radioskopie
(IEC 61223-3-8:2024)
This European Standard was approved by CENELEC on 2024-04-30. CENELEC members are bound to comply with the CEN/CENELEC
Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration.
Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC
Management Centre or to any CENELEC member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by translation
under the responsibility of a CENELEC member into its own language and notified to the CEN-CENELEC Management Centre has the
same status as the official versions.
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© 2024 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
Ref. No. EN IEC 61223-3-8:2024 E
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SIST EN IEC 61223-3-8:2024
EN IEC 61223-3-8:2024 (E)
European foreword
The text of document 62B/1347/FDIS, future edition 1 of IEC 61223-3-8, prepared by SC 62B
"Diagnostic imaging equipment" of IEC/TC 62 "Electrical equipment in medical practice" was
submitted to the IEC-CENELEC parallel vote and approved by CENELEC as EN IEC 61223-3-8:2024.
The following dates are fixed:
• latest date by which the document has to be implemented at national (dop) 2025-01-30
level by publication of an identical national standard or by endorsement
• latest date by which the national standards conflicting with the (dow) 2027-04-30
document have to be withdrawn
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CENELEC shall not be held responsible for identifying any or all such patent rights.
Any feedback and questions on this document should be directed to the users’ national committee. A
complete listing of these bodies can be found on the CENELEC website.
Endorsement notice
The text of the International Standard IEC 61223-3-8:2024 was approved by CENELEC as a
European Standard without any modification.
In
...
SLOVENSKI STANDARD
oSIST prEN IEC 61223-3-8:2022
01-oktober-2022
Vrednotenje in rutinsko preskušanje v medicinskih oddelkih za slikanje - 3-8. del:
Preskusi sprejemljivosti in konstantnosti - Slikovni učinek rentgenske opreme za
radiografijo in radioskopijo
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
Ta slovenski standard je istoveten z: prEN IEC 61223-3-8:2022
ICS:
11.040.50 Radiografska oprema Radiographic equipment
oSIST prEN IEC 61223-3-8:2022 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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oSIST prEN IEC 61223-3-8:2022
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oSIST prEN IEC 61223-3-8:2022
62B/1283/CDV
COMMITTEE DRAFT FOR VOTE (CDV)
PROJECT NUMBER:
IEC 61223-3-8 ED1
DATE OF CIRCULATION: CLOSING DATE FOR VOTING:
2022-07-15 2022-10-07
SUPERSEDES DOCUMENTS:
62B/1240/CD, 62B/1253A/CC
IEC SC 62B : DIAGNOSTIC IMAGING EQUIPMENT
SECRETARIAT: SECRETARY:
Germany Ms Regina Geierhofer
OF INTEREST TO THE FOLLOWING COMMITTEES: PROPOSED HORIZONTAL STANDARD:
SC 62C
Other TC/SCs are requested to indicate their interest, if any, in this
CDV to the secretary.
FUNCTIONS CONCERNED:
EMC ENVIRONMENT QUALITY ASSURANCE SAFETY
SUBMITTED FOR CENELEC PARALLEL VOTING NOT SUBMITTED FOR CENELEC PARALLEL VOTING
Attention IEC-CENELEC parallel voting
The attention of IEC National Committees, members of
CENELEC, is drawn to the fact that this Committee Draft
for Vote (CDV) is submitted for parallel voting.
The CENELEC members are invited to vote through the
CENELEC online voting system.
This document is still under study and subject to change. It should not be used for reference purposes.
Recipients of this document are invited to submit, with their comments, notification of any relevant patent rights of which they
are aware and to provide supporting documentation.
TITLE:
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
PROPOSED STABILITY DATE: 2026
NOTE FROM TC/SC OFFICERS:
Copyright © 2022 International Electrotechnical Commission, IEC. All rights reserved. It is permitted to download this
electronic file, to make a copy and to print out the content for the sole purpose of preparing National Committee positions.
You may not copy or "mirror" the file or printed version of the document, or any part of it, for any other purpose without
permission in writing from IEC.
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oSIST prEN IEC 61223-3-8:2022
62B/1283/CDV – 2 – IEC CDV 61223-3-8 © IEC:2022
1 CONTENTS
2
3 FOREWORD . 8
4 INTRODUCTION . 10
5 1 Scope and object . 11
6 2 Normative references . 11
7 3 Terms, definitions, symbols and abbreviated terms . 12
8 3.1 Terms and definitions. 12
9 3.2 Symbols and abbreviated terms . 20
10 4 General aspects of ACCEPTANCE TESTS . 21
11 4.1 General . 21
12 4.2 Levels of requirements . 21
13 4.2.1 General . 21
14 4.2.2 Local regulatory requirements . 21
15 4.2.3 Contractual requirements. 21
16 4.2.4 MANUFACTURER specifications . 22
17 4.3 General conditions in test procedures . 22
18 4.4 Documents and dat
...
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