EN IEC 61223-3-7:2022

Evaluation and routine testing in medical imaging departments - Part 3-7: Acceptance and constancy tests - Imaging performance of X-ray equipment for dental cone beam computed tomography

This part of IEC 61223 applies to DENTAL CONE-BEAM COMPUTED TOMOGRAPHY X-RAY EQUIPMENT, hereafter also called DENTAL CBCT EQUIPMENT, that conforms to IEC 60601-2-63:2012 and IEC 60601-2-63:2012/AMD1:2017. NOTE 1 DENTAL CBCT EQUIPMENT is a subset of DENTAL EXTRA-ORAL X-RAY EQUIPMENT. NOTE 2 DENTAL EXTRA-ORAL X-RAY EQUIPMENT can provide one or more of PANORAMIC, CEPHALOMETRIC, tomosynthesis and DENTAL CBCT imaging modalities, all of which are in the scope of the IEC 60601-2-63 basic safety and performance standard. This document applies to ACCEPTANCE TESTS and CONSTANCY TESTS on DENTAL CONE-BEAM COMPUTED TOMOGRAPHY X-RAY EQUIPMENT. The aim of ACCEPTANCE TESTS is to verify compliance of the installation or MAJOR SERVICE ACTION with specifications affecting the image quality, RADIATION OUTPUT and PATIENT positioning. The requirements specified in this document are minimal requirements. The MANUFACTURER can establish criteria for the tests described here that exceed the levels contained in this document. CONSTANCY TESTS are performed to ensure that the functional performance of ME EQUIPMENT meets established criteria and to enable the early recognition of changes in the properties of components of the ME EQUIPMENT, and to verify compliance with specifications affecting the image quality, RADIATION OUTPUT and PATIENT positioning. This document also contains requirements for the ACCOMPANYING DOCUMENTS associated with ACCEPTANCE AND CONSTANCY TESTING of the DENTAL CBCT EQUIPMENT. This document does not apply to: - aspects of thermal, EMD (electromagnetic disturbances), mechanical and electrical safety; - aspects of mechanical, electrical and software performance, unless they are essential for performing the ACCEPTANCE TESTS and CONSTANCY TESTS, and directly affect image quality, RADIATION OUTPUT and PATIENT positioning. NOTE 3 Such aspects are generally addressed by IEC 60601-1 (all parts). Equipment in the scope of IEC 61223-3-5 is excluded from the scope of this document. DENTAL EXTRA-ORAL X-RAY EQUIPMENT can provide modalities which are in the scope of IEC 61223-3-4. In this case, the respective clauses of the IEC 61223-3-4 apply. The object of this document is to establish: - the essential parameters which describe the performance of DENTAL CBCT EQUIPMENT with regard to the image quality, RADIATION OUTPUT and PATIENT positioning; - methods of testing and whether measured quantities related to those parameters comply with the specified requirements. These methods rely on non-invasive measurements performed once the installation or a MAJOR SERVICE ACTION is completed.

Bewertung und routinemäßige Prüfung in Abteilungen für medizinische Bildgebung - Teil 3-7: Abnahme- und Konstanzprüfung an zahnmedizinischen extraoralen Röntgengeräten zur digitalen Volumentomographie

Dieser Teil von IEC 61223 ist anwendbar für ZAHNMEDIZINISCHE RÖNTGENEINRICHTUNGEN ZUR DENTALEN DIGITALEN VOLUMENTOMOGRAPHIE, im weiteren Verlauf auch DENTALE DVT-EINRICHTUNGEN genannt, die IEC 60601-2-63:2012+AMD1:2017+AMD2:2021 entsprechen. ANMERKUNG 1 DENTALE DVT-EINRICHTUNGEN sind eine Teilgruppe DENTALER EXTRAORALER RÖNTGENEINRICHTUNGEN. ANMERKUNG 2 DENTALE EXTRAORALE RÖNTGENEINRICHTUNGEN können eine oder mehrere PANORAMA-, KEPHALOMETRISCHE, Tomosynthese- und dentale DVT-Bildgebungsmodalitäten bieten, die alle im Anwendungsbereich der grundlegenden Sicherheits- und Leistungsnorm IEC 60601-2-63 liegen. Dieses Dokument ist anwendbar für ABNAHMEPRÜFUNGEN und KONSTANZPRÜFUNGEN an ZAHNMEDIZINISCHEN RÖNTGENEINRICHTUNGEN ZUR DENTALEN DIGITALEN VOLUMENTOMOGRAPHIE. Ziel der ABNAHMEPRÜFUNGEN ist es, die Konformität der Installation oder WESENTLICHEN WARTUNGSMAßNAHME mit Spezifikationen mit Einfluss auf die Bildqualität, die STRAHLUNGSAUSBEUTE und die PATIENTENpositionierung zu überprüfen. Die in diesem Dokument festgelegten Anforderungen sind Mindestanforderungen. Der Hersteller kann Kriterien für die hier beschriebenen Prüfungen festlegen, die das in diesem Dokument enthaltene Niveau übersteigen. KONSTANZPRÜFUNGEN werden durchgeführt, um sicherzustellen, dass die Leistung MEDIZINISCHER ELEKTRISCHER GERÄTE die festgelegten Kriterien erfüllt, und um Veränderungen der Eigenschaften des MEDIZINISCHEN ELEKTRISCHEN GERÄTS frühzeitig zu erkennen und um die Konformität mit Spezifikationen mit Einfluss auf die Bildqualität, die STRAHLUNGSAUSBEUTE und die PATIENTENpositionierung zu überprüfen. Dieses Dokument enthält außerdem Anforderungen an die BEGLEITDOKUMENTE in Verbindung mit der ABNAHME- UND KONSTANZPRÜFUNG von DENTALEN DVT-EINRICHTUNGEN. Dieses Dokument ist nicht anwendbar für:  Aspekte der thermischen, EMD (elektromagnetische Störung), mechanischen und elektrischen Sicherheit;  Aspekte des mechanischen, elektrischen und Software-Verhalten, außer wenn diese für die Durchführung der ABNAHMEPRÜFUNGEN und KONSTANZPRÜFUNGEN wesentlich sind und die Bildqualität, die STRAHLUNGSAUSBEUTE sowie die PATIENTENpositionierung direkt beeinflussen. ANMERKUNG 3 Solche Aspekte werden grundsätzlich durch IEC 60601-1 (alle Teile) behandelt. Einrichtungen im Anwendungsbereich von IEC 61223-3-5 sind grundsätzlich vom Anwendungsbereich dieses Dokuments ausgeschlossen. DENTALE EXTRAORALE RÖNTGENEINRICHTUNGEN können Modalitäten bieten, die im Anwendungsbereich der IEC 61223-3-4 enthalten sind. In diesem Fall gelten die entsprechenden Abschnitte der Normenreihe IEC 61223-3-4. Der Zweck dieses Dokuments ist es, Folgendes festzulegen:  die wesentlichen Parameter, die die Leistung DENTALER DVT-EINRICHTUNGEN im Hinblick auf die Bildqualität, die STRAHLUNGSAUSBEUTE und die PATIENTENpositionierung beschreiben;  die Verfahren zur Prüfung und ob die gemessenen Größen in Bezug auf diese Parameter den festgelegten Anforderungen entsprechen. Diese Verfahren beruhen auf nicht-invasiven Messungen, die ausgeführt werden, sobald die Installation oder eine WESENTLICHE WARTUNGSMAßNAHME abgeschlossen ist.

Essais d'évaluation et de routine dans les services d'imagerie médicale - Partie 3-7: Essais d'acceptation et de constance - Performance d'imagerie des appareils à rayonnement X pour la tomodensitométrie dentaire à faisceau conique

L'IEC 61223-3-7:2021 s'applique aux APPAREILS À RAYONNEMENT X DENTAIRES à TOMODENSITOMÉTRIE À FAISCEAU CONIQUE, ci-après également appelés APPAREILS CBCT DENTAIRES, qui sont conformes à IEC 60601-2-63:2012+AMD1:2017+AMD2:2021. Le présent document s'applique aux ESSAIS DE RÉCEPTION et aux ESSAIS DE CONSTANCE des APPAREILS À RAYONNEMENT X DENTAIRES À TOMODENSITOMÉTRIE À FAISCEAU CONIQUE. Les ESSAIS DE RÉCEPTION ont pour objet de vérifier la conformité de l'installation ou d'une OPÉRATION DE MAINTENANCE IMPORTANTE aux spécifications relatives à la qualité de l'image, au RAYONNEMENT DE SORTIE et au positionnement du PATIENT. Les exigences spécifiées dans le présent document sont des exigences minimales. Dans le cadre des essais décrits ici, le FABRICANT peut établir des critères qui dépassent les niveaux indiqués dans le présent document. Les ESSAIS DE CONSTANCE ont pour objet d'assurer que les performances fonctionnelles de l'APPAREIL EM satisfassent aux critères établis et de permettre l'identification précoce des modifications des propriétés des composants de l'APPAREIL EM, mais également de vérifier la conformité aux spécifications relatives à la qualité de l'image, au RAYONNEMENT DE SORTIE et au positionnement du PATIENT. Le présent document contient également les exigences associées aux DOCUMENTS D'ACCOMPAGNEMENT liés aux ESSAIS DE RÉCEPTION ET DE CONSTANCE de l'APPAREIL CBCT DENTAIRE. Le présent document ne s'applique pas: – aux aspects concernant la sécurité thermique, la sécurité liée aux perturbations électromagnétiques (EMD - electromagnetic disturbances), la sécurité mécanique et la sécurité électrique; – aux aspects concernant les performances mécaniques, électriques et logicielles, à moins qu'ils ne soient essentiels à l'exécution des ESSAIS DE RÉCEPTION et des ESSAIS DE CONSTANCE, et qu'ils affectent directement la qualité d'image, le RAYONNEMENT DE SORTIE et le positionnement du PATIENT. NOTE 3 Ces aspects sont en général traités dans l’IEC 60601-1 (toutes les parties). Le matériel relevant du domaine d'application de l'IEC 61223-3-5 est exclu du domaine d'application du présent document. Certaines modalités des APPAREILS À RAYONNEMENT X DENTAIRES EXTRA-ORAUX peuvent relever du domaine d'application de l’IEC 61223-3-4. Dans ce cas, les articles correspondants de l’IEC 61223-3-4 s'appliquent. Le présent document a pour objet d'établir: – les paramètres importants qui décrivent les performances des APPAREILS CBCT DENTAIRES en ce qui concerne la qualité d'image, le RAYONNEMENT DE SORTIE et le positionnement du PATIENT; – les méthodes d'essai et si les grandeurs mesurées liées à ces paramètres sont conformes aux exigences spécifiées. Ces méthodes s'appuient sur des mesurages non invasifs exécutés à l'issue de l'installation ou d'une OPÉRATION DE MAINTENANCE IMPORTANTE.

Vrednotenje in rutinsko preskušanje v medicinskih oddelkih za slikanje - 3-7. del: Preskusi sprejemljivosti in konstantnosti - Slikovni učinek rentgenske opreme za računalniško tomografijo s stožčastim snopom (IEC 61223-3-7:2021)

Ta del standarda IEC 61223 se uporablja za RENTGENSKO OPREMO ZA RAČUNALNIŠKO TOMOGRAFIJO S STOŽČASTIM SNOPOM
(v nadaljevanju: OPREMA CBCT), ki je skladna s standardom IEC 60601-2-63:2012+AMD1:2017+AMD2:2021.
OPOMBA 1: OPREMA CBCT je podskupina EKSTRAORALNEGA ZOBNEGA RENTGENA.
OPOMBA 2: EKSTRAORALNI ZOBNI RENTGEN lahko zagotovi eno ali več modalitet PANORAMSKEGA slikanja, CEFALOMETRIČNEGA slikanja, tomosinteze in slikanja CBCT, ki spadajo na področje uporabe standarda IEC 60601-2-63 o osnovni varnosti in lastnostih.
Ta dokument se uporablja za PREVZEMNE PRESKUSE in PRESKUSE NESPREMENLJIVOSTI RENTGENSKE OPREME ZA RAČUNALNIŠKO TOMOGRAFIJO S STOŽČASTIM SNOPOM.
Namen PREVZEMNIH PRESKUSOV je potrditi skladnost namestitve ali VEČJEGA SERVISNEGA DELA s specifikacijami, ki vplivajo na kakovost slike, IZHODNO SEVANJE in položaj PREISKOVANCA.  V tem dokumentu so navedene minimalne zahteve. PROIZVAJALEC lahko določi merila za opisane preskuse, ki presegajo ravni v tem dokumentu. PRESKUSI NESPREMENLJIVOSTI se izvajajo, da se zagotovi, da zmogljivost delovanja ELEKTROMEDICINSKE OPREME ustreza uveljavljenim merilom, ter da se omogoči zgodnje prepoznavanje sprememb v lastnostih komponent ELEKTROMEDICINSKE OPREME in preveri skladnost s specifikacijami, ki vplivajo na kakovost slike, IZHODNO SEVANJE in položaj PREISKOVANCA.
Ta dokument vsebuje tudi zahteve za SPREMNE DOKUMENTE v zvezi s PREVZEMNIM PRESKUSOM IN PRESKUSOM NESPREMENLJIVOSTI OPREME CBCT.
Ta dokument se ne uporablja za:
– vidike termične, EMD (elektromagnetne motnje), mehanske in električne varnosti;
– vidike mehanskega in električnega delovanja ter delovanja programske opreme, razen če so ti bistveni za izvajanje PREVZEMNIH PRESKUSOV in PRESKUSOV NESPREMENLJIVOSTI ter neposredno vplivajo na kakovost slike, IZHODNO SEVANJE in položaj PREISKOVANCA.
OPOMBA 3: Ti vidiki so splošno obravnavani v standardu IEC 60601-1 (vsi deli).
Oprema, zajeta v standardu IEC 61223-3-5, ne spada na področje uporabe tega dokumenta.
EKSTRAORALNI ZOBNI RENTGEN lahko zagotovi modalitete, ki spadajo na področje uporabe standarda IEC 61223-3-4. V tem primeru se uporabljajo ustrezne točke standarda IEC 61223-3-4.
Cilj tega dokumenta je določiti:
– osnovne parametre, ki opisujejo delovanje OPREME CBCT z zvezi s kakovostjo slike, IZHODNIM SEVANJEM in položajem PREISKOVANCA;
– postopke za preskušanje in ugotavljanje, ali izmerjene količine, povezane s temi parametri, izpolnjujejo podane zahteve.
Ti postopki se opirajo na neinvazivne meritve, ki se izvedejo po namestitvi VEČJEGA SERVISNEGA DELA.

General Information

• Status: Published
• Publication Date: 03-Feb-2022
• ICS: 11.040.50 - Radiographic equipment
• Technical Committee: CLC/TC 62 - Electrical equipment in medical practice
• Drafting Committee: IEC/SC 62B - IEC_SC_62B
• Current Stage: 6060 - Document made available - Publishing
• Start Date: 04-Feb-2022
• Completion Date: 04-Feb-2022
• Ref Project: SIST EN IEC 61223-3-7:2022 - Evaluation and routine testing in medical imaging departments - Part 3-7: Acceptance and constancy tests - Imaging performance of X-ray equipment for dental cone beam computed tomography (IEC 61223-3-7:2021)

Standards Content (Sample)

SLOVENSKI STANDARD
01-april-2022
Vrednotenje in rutinsko preskušanje v medicinskih oddelkih za slikanje - 3-7. del:
Preskusi sprejemljivosti in konstantnosti - Slikovni učinek rentgenske opreme za
računalniško tomografijo s stožčastim snopom (IEC 61223-3-7:2021)
Evaluation and routine testing in medical imaging departments - Part 3-7: Acceptance
and constancy tests - Imaging performance of X-ray equipment for dental cone beam
computed tomography (IEC 61223-3-7:2021)
Bewertung und routinemäßige Prüfung in Abteilungen für medizinische Bildgebung - Teil
3-7: Abnahmeprüfung und Qualitätssicherung von zahnärztlichen extraoralen
Röntgengeräten in Verwendung mit zahnärztlichen Volumentomografiegeräten (IEC
61223-3-7:2021)
Essais d'évaluation et de routine dans les services d'imagerie médicale - Partie 3-7:
Essais d'acceptation et de constance - Performance d'imagerie des appareils à
rayonnement X pour la tomodensitométrie dentaire à faisceau conique (IEC 61223-3-
7:2021)
Ta slovenski standard je istoveten z: EN IEC 61223-3-7:2022
ICS:
11.040.50 Radiografska oprema Radiographic equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD EN IEC 61223-3-7

NORME EUROPÉENNE
EUROPÄISCHE NORM February 2022
ICS 11.040.50
English Version
Evaluation and routine testing in medical imaging departments -
Part 3-7: Acceptance and constancy tests - Imaging
performance of X-ray equipment for dental cone beam computed
tomography
(IEC 61223-3-7:2021)
Essais d'évaluation et de routine dans les services Bewertung und routinemäßige Prüfung in Abteilungen für
d'imagerie médicale - Partie 3-7: Essais d'acceptation et de medizinische Bildgebung - Teil 3-7: Abnahmeprüfung und
constance - Performance d'imagerie des appareils à Qualitätssicherung von zahnärztlichen extraoralen
rayonnement X pour la tomodensitométrie dentaire à Röntgengeräten in Verwendung mit zahnärztlichen
faisceau conique Volumentomografiegeräten
(IEC 61223-3-7:2021) (IEC 61223-3-7:2021)
This European Standard was approved by CENELEC on 2022-01-11. 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.
CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus, the Czech Republic,
Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the
Netherlands, Norway, Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.

European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2022 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
Ref. No. EN IEC 61223-3-7:2022 E

European foreword
The text of document 62B/1249/FDIS, future edition 1 of IEC 61223-3-7, 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 61223-3-7:2022.
The following dates are fixed:
• latest date by which the document has to be implemented at national (dop) 2022–10–11
level by publication of an identical national standard or by endorsement
• latest date by which the national standards conflicting with the (dow) 2025–01–11
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 61223-3-7:2021 was approved by CENELEC as a
European Standard without any modification.
In the official version, for Bibliography, the following notes have to be added for the standards
indicated:
IEC 60601-1 (series) NOTE Harmonized as EN 60601-1-9 (series)
IEC 60601-2-44:2009 NOTE Harmonized as EN 60601-2-44:2009 (not modified) +A11:2011
IEC 60601-2-54:2009 NOTE Harmonized as EN 60601-2-54:2009 (not modified)
IEC 60601-2-63:2012 NOTE Harmonized as EN 60601-2-63:2015 (not modified)
IEC 61223-3-4:2000 NOTE Harmonized as EN 61223-3-4:2000 (not modified)
IEC 61223-3-5:2019 NOTE Harmonized as EN IEC 61223-3-5:2019 (not modified)
IEC 61910-1 NOTE Harmonized as EN 61910-1
IEC 62220-1-1:2015 NOTE Harmonized as EN 62220-1-1:2015 (not modified)
Annex ZA
(normative)
Normative references to international publications
with their corresponding European publications
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments)
applies.
NOTE 1 Where an International Publication has been modified by common modifications, indicated by (mod), the
relevant EN/HD applies.
NOTE 2 Up-to-date information on the latest versions of the European Standards listed in this annex is available
here: www.cenelec.eu.
Publication Year Title EN/HD Year
IEC 60601-1-3 2008 Medical electrical equipment – Part EN 60601-1-3 2008
1–3: General requirements for basic
safety and essential performance –
Collateral Standard: Radiation
protection in diagnostic X-ray
equipment
+ corrigendum Mar. 2010
/A11 2016
IEC 60336 - Medical electrical equipment – X-ray EN/IEC 60336 -
tube assemblies for medical
diagnosis – Characteristics of focal
spots
IEC 61223-3-7 ®
Edition 1.0 2021-12
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
Evaluation and routine testing in medical imaging departments –

Part 3-7: Acceptance and constancy tests – Imaging performance of X-ray

equipment for dental cone beam computed tomography

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

Partie 3-7: Essais d'acceptation et de constance – Performance d'imagerie des

appareils à rayonnement X pour la tomodensitométrie dentaire à faisceau

conique
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 11.040.50 ISBN 978-2-8322-1032-4

– 2 – IEC 61223-3-7:2021 © IEC 2021
CONTENTS
FOREWORD . 5
INTRODUCTION . 7
1 Scope and object . 8
2 Normative references . 9
3 Terms and definitions . 9
4 General aspects of ACCEPTANCE TESTS and CONSTANCY TESTS . 11
4.1 Preconditions . 11
4.2 General conditions to be considered in testing . 11
4.2.1 PHANTOM . 11
4.2.2 AIR KERMA . 12
4.3 Documents and data for the tests in the ACCOMPANYING DOCUMENTS . 12
4.4 Measuring INSTRUMENTS . 12
4.5 MAJOR SERVICE ACTION . 12
4.6 Record and establishment of BASELINE VALUES and TEST frequencies . 12
5 Performance tests for DENTAL CBCT EQUIPMENT . 13
5.1 Visual inspection . 13
5.2 Functional test . 13
5.3 Relationship between X-RAY FIELD and EFFECTIVE IMAGE RECEPTION AREA . 13
5.3.1 Requirement . 13
5.3.2 Test . 13
5.4 Reproducibility of the AIR KERMA . 13
5.4.1 Requirement . 13
5.4.2 Test . 14
5.5 Geometric accuracy . 14
5.5.1 General . 14
5.5.2 Requirement . 14
5.5.3 Test . 14
5.6 * Spatial resolution . 14
5.6.1 General . 14
5.6.2 Requirement . 14
5.6.3 Test . 15
5.7 * CONTRAST TO NOISE RATIO . 15
5.7.1 General . 15
5.7.2 Requirement . 15
5.7.3 Test . 15
5.8 * Acceptance index . 15
5.8.1 General . 15
5.8.2 Requirement . 15
5.8.3 Test . 15
5.9 * Homogeneity . 16
5.9.1 General . 16
5.9.2 Requirement . 16
5.9.3 Test . 16
5.10 ARTEFACTS . 17
5.10.1 General . 17
5.10.2 Requirement . 17

IEC 61223-3-7:2021 © IEC 2021 – 3 –
5.10.3 Test . 17
Annex A (informative) Rationales . 18
A.1 General conditions to be considered in PHANTOM based test procedures. 18
A.2 HOMOGENEITY . 18
A.3 Simplified determination of the MODULATION TRANSFER FUNCTION . 18
A.4 Spatial resolution . 18
A.5 CONTRAST TO NOISE RATIO . 19
A.6 AIR KERMA . 19
A.7 ACCEPTANCE INDEX . 21
Annex B (informative) Particular guidance and rationale . 23
B.1 Execution of the performance tests . 23
B.2 MODULATION TRANSFER FUNCTION . 23
B.2.1 General . 23
B.2.2 Scan geometries for the air kerma index . 24
B.2.3 HOMOGENEITY. 25
Annex C (normative) PHANTOM – Design . 26
Annex D (normative) Determination of the MODULATION TRANSFER FUNCTION . 29
D.1 MTF method 1: Simplified determination of the MODULATION TRANSFER
FUNCTION . 29
D.1.1 General . 29
D.1.2 Calculation procedure . 29
D.2 MTF method 2: Determination of the MODULATION TRANSFER FUNCTION . 30
Annex E (normative) Calculation of the CONTRAST TO NOISE ratio . 32
E.1 Overview. 32
E.1.1 General . 32
E.1.2 Procedure 1 . 32
E.1.3 Procedure 2 . 32
E.2 Calculation procedure . 33
E.2.1 General . 33
E.2.2 Procedure 1 . 33
E.2.3 Procedure 2 . 34
Annex F (informative) Examples of ARTEFACTS seen in ACCEPTANCE and CONSTANCY
TESTS . 35
F.1 General . 35
F.2 Ring ARTEFACTS . 35
F.3 Geometry ARTEFACTS . 36
F.3.1 General . 36
F.3.2 Blurred edges visible at the interface between PVC and air region . 36
F.3.3 Shading close to the edge of the PHANTOM . 37
Annex G (informative) AIR KERMA in DENTAL CBCT EQUIPMENT . 38
G.1 Background. 38
G.2 Conditions for the measurement of AIR KERMA in DENTAL CBCT EQUIPMENT . 38
G.2.1 Imaged volume . 38
G.2.2 Scanning geometry . 38
G.2.3 Measurement devices . 38
G.3 Summary . 39
Bibliography . 40
Index of defined terms . 41

– 4 – IEC 61223-3-7:2021 © IEC 2021

Figure A.1 – Geometry (example 1) . 20
Figure A.2 – Geometry (example 2) . 21
Figure B.1 – Example of the position and borders of the ROI for determination of the
MODULATION TRANSFER FUNCTION . 23
Figure B.2 – Example for the representation of the MODULATION TRANSFER FUNCTION . 24
Figure B.3 – Horizontal slice through a scan geometry (example 1) . 24
Figure B.4 – Horizontal slice through a scan geometry (example 2) . 25
Figure B.5 – Example for the position and borders of the fields for the determination of
HOMOGENEITY . 25
Figure C.1 – Structure and example of placement of the PHANTOM including the optional
parts (2a and 2d) within the path of the RADIATION BEAM . 26
Figure C.2 – Homogeneous parts of the PHANTOM . 27
Figure C.3 – Structure elements of the PHANTOM, axial and sagittal sections . 28
Figure E.1 – Placement of a REGION OF INTEREST (ROI) . 32
Figure E.2 – Example of the placement of REGION OF INTEREST (ROI) . 33
Figure F.1 – Axial slice illustrating a ring ARTEFACT at PMMA region of the PHANTOM . 35
Figure F.2 – Axial slice illustrating a ring ARTEFACT at PMMA/PVC region of the
PHANTOM . 36
Figure F.3 – Reference image without geometry ARTEFACTS . 36
Figure F.4 – Blurred edges visible at the interface between PVC and air region . 37
Figure F.5 – Shading close to the edge of the PHANTOM . 37

Table 1 – Additional requirements in ACCOMPANYING DOCUMENTS . 12

IEC 61223-3-7:2021 © IEC 2021 – 5 –
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
EVALUATION AND ROUTINE TESTING
IN MEDICAL IMAGING DEPARTMENTS –

Part 3-7: Acceptance and constancy tests – Imaging performance
of X-ray equipment for dental cone beam computed tomography

FOREWORD
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rights. IEC shall not be held responsible for identifying any or all such patent rights.
International Standard IEC 61223-3-7 has been prepared by subcommittee 62B: Diagnostic
imaging equipment, of IEC technical committee 62: Electrical equipment in medical practice.
The text of this International Standard is based on the following documents:
FDIS Report on voting
62B/1249/FDIS 62B/1255/RVD
Full information on the voting for its approval can be found in the report on voting indicated in
the above table.
The language used for the development of this International Standard is English.

– 6 – IEC 61223-3-7:2021 © IEC 2021
This document was drafted in accordance with ISO/IEC Directives, Part 2, and developed in
accordance with ISO/IEC Directives, Part 1 and ISO/IEC Directives, IEC Supplement, available
at www.iec.ch/members_experts/refdocs. The main document types developed by IEC are
described in greater detail at www.iec.ch/standardsdev/publications.
In this document, the following print types are used:
– requirements and definitions: roman type.
– test specifications: italic type.
– informative material appearing outside of tables, such as notes, examples and references: smaller type;
normative text of tables is also in a smaller type.
– TERMS DEFINED IN CLAUSE 3 OF THIS DOCUMENT OR AS NOTED: SMALL CAPITALS.
References to clauses within this document are preceded by the term "Clause" followed by the
clause number. References to subclauses within this document are by number only.
In this document, the conjunctive "or" is used as an "inclusive or" so a statement is true if any
combination of the conditions is true.
The verbal forms used in this document conform to usage described in Clause 7 of the
ISO/IEC Directives, Part 2. For the purposes of this document, the auxiliary verb:
– "shall" means that compliance with a requirement or a test is mandatory for compliance with
this document;
– "should" means that compliance with a requirement or a test is recommended but is not
mandatory for compliance with this document;
– "may" is used to describe a permissible way to achieve compliance with a requirement or
test.
An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title
indicates that there is guidance or rationale related to that item in Annex A.
A list of all parts of the IEC 61223 series, published under the general title Evaluation and
routine testing in medical imaging departments, can be found on the IEC website.
The committee has decided that the contents of this document will remain unchanged until the
stability date indicated on the IEC website under webstore.iec.ch in the data related to the
specific document. At this date, the document will be
• reconfirmed,
• withdrawn,
• replaced by a revised edition, or
• amended.
IMPORTANT – The 'colour inside' logo on the cover page of this publication indicates that it
contains colours which are considered to be useful for the correct understanding of its
contents. Users should therefore print this document using a colour printer.

IEC 61223-3-7:2021 © IEC 2021 – 7 –
INTRODUCTION
This document provides methods for acceptance testing and constancy testing for DENTAL CONE-
BEAM COMPUTED TOMOGRAPHY X-RAY EQUIPMENT.
The complete set of ACCEPTANCE TESTS is to be carried out after the EQUIPMENT has been
installed, or a subset of the tests is to be carried out after each MAJOR SERVICE ACTION that is
made to installed EQUIPMENT. This is done to facilitate verification of applicable safety and
performance standards, regulations, and published and/or contractual specifications that
influence the image quality, RADIATION OUTPUT and PATIENT positioning.
The complete set of CONSTANCY TESTS is to be carried out periodically at installed EQUIPMENT.
This is done to facilitate verification of stability of the EQUIPMENT according to the applicable
safety and performance standards, regulations, and published and/or contractual specifications
that influence the image quality, RADIATION OUTPUT and PATIENT positioning.
To maintain the homogeneity of this IEC standard with the other IEC standards addressing
DENTAL EXTRA-ORAL X-RAY EQUIPMENT, the measuring methods and the terminology are taken as
applicable from the safety standard IEC 60601-2-63:2012+AMD1:2017+AMD2:2021.
Some provisions or statements in this document require additional information, which is
presented in the annexes.
– 8 – IEC 61223-3-7:2021 © IEC 2021
EVALUATION AND ROUTINE TESTING
IN MEDICAL IMAGING DEPARTMENTS –

Part 3-7: Acceptance and constancy tests – Imaging performance
of X-ray equipment for dental cone beam computed tomography

1 Scope and object
This part of IEC 61223 applies to DENTAL CONE-BEAM COMPUTED TOMOGRAPHY X-RAY EQUIPMENT,
hereafter also called DENTAL CBCT EQUIPMENT, that conforms to IEC 60601-2-
63:2012+AMD1:2017+AMD2:2021.
NOTE 1 DENTAL CBCT EQUIPMENT is a subset of DENTAL EXTRA-ORAL X-RAY EQUIPMENT.
NOTE 2 DENTAL EXTRA-ORAL X-RAY EQUIPMENT can provide one or more of PANORAMIC, CEPHALOMETRIC,
tomosynthesis and DENTAL CBCT imaging modalities, all of which are in the scope of the IEC 60601-2-63 basic safety
and performance standard.
This document applies to ACCEPTANCE TESTS and CONSTANCY TESTS on DENTAL CONE-BEAM
COMPUTED TOMOGRAPHY X-RAY EQUIPMENT.
The aim of ACCEPTANCE TESTS is to verify compliance of the installation or MAJOR SERVICE ACTION
with specifications affecting the image quality, RADIATION OUTPUT and PATIENT positioning.
The requirements specified in this document are minimal requirements. The MANUFACTURER can
establish criteria for the tests described here that exceed the levels contained in this document.
CONSTANCY TESTS are performed to ensure that the functional performance of ME EQUIPMENT
meets established criteria and to enable the early recognition of changes in the properties of
components of the ME EQUIPMENT, and to verify compliance with specifications affecting the
image quality, RADIATION OUTPUT and PATIENT positioning.
This document also contains requirements for the ACCOMPANYING DOCUMENTS associated with
ACCEPTANCE AND CONSTANCY TESTING of the DENTAL CBCT EQUIPMENT.
This document does not apply to:
– aspects of thermal, EMD (electromagnetic disturbances), mechanical and electrical safety;
– aspects of mechanical, electrical and software performance, unless they are essential for
performing the ACCEPTANCE TESTS and CONSTANCY TESTS, and directly affect image quality,
RADIATION OUTPUT and PATIENT positioning.
NOTE 3 Such aspects are generally addressed by IEC 60601-1 (all parts).
Equipment in the scope of IEC 61223-3-5 is excluded from the scope of this document.
DENTAL EXTRA-ORAL X-RAY EQUIPMENT can provide modalities which are in the scope of
IEC 61223-3-4. In this case, the respective clauses of the IEC 61223-3-4 apply.
The object of this document is to establish:
– the essential parameters which describe the performance of DENTAL CBCT EQUIPMENT with
regard to the image quality, RADIATION OUTPUT and PATIENT positioning;
– methods of testing and whether measured quantities related to those parameters comply
with the specified requirements.

IEC 61223-3-7:2021 © IEC 2021 – 9 –
These methods rely on non-invasive measurements performed once the installation or a MAJOR
SERVICE ACTION is completed.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies.
For undated references, the latest edition of the referenced document (including any
amendments) applies.
IEC 60601-1-3:2008, Medical electrical equipment–Part 1-3: General requirements for basic
safety and essential performance – Collateral Standard: Radiation protection in diagnostic X-ray
equipment
IEC 60336, Medical electrical equipment – X-ray tube assemblies for medical diagnosis –
Characteristics of focal spots
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminological databases for use in standardization at the following
addresses:
• IEC Electropedia: available at http://www.electropedia.org/
• ISO Online browsing platform: available at http://www.iso.org/obp
NOTE An index of defined terms is found on page 41.
3.1
BASELINE VALUE
reference value used for constancy testing
Note 1 to entry: BASELINE VALUES are usually established by the completed ACCEPTANCE TEST.
3.2
CONE BEAM COMPUTED TOMOGRAPHY
CBCT
imaging procedure that generates a three-dimensional volumetric representation from the
reconstruction of a number of two-dimensional, digital X-ray images
Note 1 to entry: DENTAL CBCT is a subset of DENTAL VOLUMETRIC RECONSTRUCTION (DVR) – see 201.3.203 of
IEC 60601-2-63:2012.
3.3
ORIGINAL DATASET
result of the transformation of the PROJECTION data into a volumetric dataset, including the
correction of known, reproducible inhomogeneity of the system and reconstruction
Note 1 to entry: The inhomogeneity is also referred to as "fixed-pattern-noise".
3.4
POSITIONING AIDS
feature that enables the correct positioning of the PATIENT
EXAMPLE: Scout view, presentation of the median sagittal plane, lasers, bite block, head holder, chair.

– 10 – IEC 61223-3-7:2021 © IEC 2021
3.5
ARTEFACT
apparent structure, visible in the image, which does not represent a structure within the object
[SOURCE: IEC 61223-3-4:2000, 3.3.1]
3.6
RAY FIELD
X-
surface of the field irradiated by X-rays at the plane of the image receptor, limited by the decay
of the AIR KERMA to 25 % of the value present in the centre of the X-RAY FIELD
3.7
RESOLUTION INDEX 10
SPATIAL FREQUENCY at which the MODULATION TRANSFER FUNCTION takes the 10 % value
Note 1 to entry: MTF 10 term can also be used.
3.8
RESOLUTION INDEX 50
SPATIAL FREQUENCY at which the MODULATION TRANSFER FUNCTION takes the 50 % value
Note 1 to entry: MTF 50 term can also be used.
3.9
ACCEPTANCE INDEX
AI
index that describes the performance of the device in relation to image quality and AIR KERMA
3.10
HOMOGENEITY
H
consistency of voxel values across one tomographic slice of a specified uniformly dense
material
3.11
CONTRAST TO NOISE RATIO
CNR
quantity describing the ability to distinguish the contrast of selected objects in the presence of
noise
3.12
MODULATION TRANSFER FUNCTION
MTF
dimensional estimation of the three-dimensional modulation properties of the system
3.13
ACCEPTANCE TEST
test carried out after new ME EQUIPMENT has been installed, or a MAJOR SERVICE ACTION has
been performed on existing ME EQUIPMENT, in order to verify compliance with MANUFACTURER’s
specifications or established requirements
3.14
CONSTANCY TEST
test carried out periodically in order to verify continued compliance with MANUFACTURER’s
specifications or established requirements

IEC 61223-3-7:2021 © IEC 2021 – 11 –
3.15
MAJOR SERVICE ACTION
action that may significantly affect RADIATION OUTPUT, image quality, or PATIENT positioning
EXAMPLE Replacement of the X-RAY GENERATOR, installation of a new BEAM LIMITING DEVICE, installation of a new
image receptor, and reinstalling the DENTAL CBCT equipment.
Note 1 to entry: The MANUFACTURER may provide a list of MAJOR SERVICE ACTIONS.
Note 2 to entry: See IEC 61223-3-5:2019, 3.13.
3.16
DENTAL
related to structures in the dento-maxillo-facial region of the PATIENT, including dentition
[SOURCE: IEC 60601-2-63:2012, 201.3.202]
3.17
DOSE AREA PRODUCT
DAP
product of the area of the cross-section of an X-RAY BEAM and the averaged AIR KERMA over that
cross-section
Note 1 to entry: An alternative term for "DOSE AREA PRODUCT" (DAP) is "AIR KERMA AREA PRODUCT" (KAP) as used in
ICRP 135.
[SOURCE: IEC 60601-2-54:2009, 201.3.203, modified – The abbreviated term "DAP" has been
added, and the unit deleted.]
3.18
RADIATION OUTPUT
AIR KERMA per CURRENT TIME PRODUCT at a given distance from the FOCAL SPOT in the primary
X-RAY BEAM
[SOURCE: IEC 61223-3-4:2000, 3.3.4, modified – The unit has been deleted from the
definition.]
4 General aspects of ACCEPTANCE TESTS and CONSTANCY TESTS
4.1 Preconditions
ACCEPTANCE TESTS shall be performed on EQUIPMENT which has been installed, or received a
MAJOR SERVICE ACTION, according to the ACCOMPANYING DOCUMENTS.
4.2 General conditions to be considered in testing
4.2.1 PHANTOM
The ACCEPTANCE and CONSTANCY TESTS are based on the evaluation of images acquired with
the PHANTOM such as described in the Annex C.
The PHANTOM shall be positioned in such a way that the tests from 5.5 to 5.10 can be performed.
Means for mounting the PHANTOM to the EQUIPMENT shall be made available by the
MANUFACTURER.
The PHANTOM image data shall be acquired and reconstructed using standard parameters
appropriate for a PATIENT. The same parameters established in ACCEPTANCE TESTS shall be used
in CONSTANCY TESTS.
– 12 – IEC 61223-3-7:2021 © IEC 2021
Means for analysing the ORIGINAL DATASET of the PHANTOM shall be made available by the
MANUFACTURER.
NOTE 1 The MANUFACTURER can provide these parameters in the ACCOMPANYING DOCUMENTS.
NOTE 2 For finding issues before use, it is enough to perform this testing at just one volume/setting.
4.2.2 AIR KERMA
The AIR KERMA exposure conditions shall be the same as the parameters used for the PHANTOM
based testing.
4.3 Documents and data for the tests in the ACCOMPANYING DOCUMENTS
Additional requirements for PROCEDURES in ACCOMPANYING DOCUMENTS (which include
instructions for use and technical description) are found in the subclauses listed in Table 1.
The ACCOMPANYING DOCUMENTS shall contain quality control PROCEDURES to be performed on
the ME EQUIPMENT by the RESPONSIBLE ORGANIZATION. These shall include ACCEPTANCE TEST and
CONSTANCY TEST criteria for the tests.
Table 1 – Additional requirements in ACCOMPANYING DOCUMENTS
Title Subclause
Preconditions 4.1
General conditions to be considered in testing 4.2
Establishment of BASELINE VALUES and TEST frequencies 4.6
Visual inspection 5.1
ACCEPTANCE INDEX 5.8
ARTEFACTS 5.10
4.4 Measuring INSTRUMENTS
The DIAGNOSTIC DOSIMETER used for ACCEPTANCE or CONSTANCY TESTS shall be calibrated to
applicable regulatory requirements.
NOTE There might be local regulations regarding calibration requirements.
4.5 MAJOR SERVICE ACTION
After a MAJOR SERVICE ACTION, an ACCEPTANCE TESt shall be performed.
4.6 Record and establishment of BASELINE VALUES and TEST frequencies
The testing conditions and results of performed ACCEPTANCE and CONSTANCY TESTS shall be
recorded. The records shall be maintained by the RESPONSIBLE ORGANISATION.
For the AIR KERMA, CNR and RESOLUTION INDEX 50 tests, the baseline values shall be established
during the ACCEPTANCE TESTS.
The ACCOMPANYING DOCUMENTS shall provide recommended frequencies for CONSTANCY TESTS.
The minimum frequency for CONSTANCY TESTS of CNR, RESOLUTION INDEX 10 and 50,
HOMOGENEITY and geometric accuracy shall be every 6 months. The minimum frequency for
CONSTANCY TESTS of AIR KERMA and alignment of X-RAY FIELD and EFFECTIVE IMAGE RECEPTION
AREA shall be every 5 years.
IEC 61223-3-7:2021 © IEC 2021 – 13 –
NOTE It is possible national regulations specify a different frequency of testing.
5 Performance tests for DENTAL CBCT EQUIPMENT
5.1 Visual inspection
The presence of the following declarations shall be checked as part of the visual inspection of
the marking on the outside of the ME EQUIPMENT and ACCOMPANYING DOCUMENTS:
– characteristics such as X-RAY TUBE VOLTAGE (kV), X-RAY TUBE CURRENT (mA), IRRADIATION
TIME (s);
– NOMINAL VALUE of the FOCAL SPOT according to IEC 60336;
– value of the TOTAL FILTRATION according to IEC 60601-1-3.
5.2 Functional test
The following functionality shall be checked:
– positioning aids as described by the MANUFACTURER;
– display of the DOSE AREA PRODUCT.
The functionalities of the system shall be tested according to the procedure provided by the
ACCOMPANYING DOCUMENTS.
NOTE 1 Local regulatory requirements can require specific tests.
NOTE 2 Examples of functional tests can be positioning aids, display devices, mechanical movement supporting
the X-RAY TUBE ASSEMBLY and X-RAY IMAGE RECEPTOR.
5.3 Relationship between X-RAY FIELD and EFFECTIVE IMAGE RECEPTION AREA
5.3.1 Requirement
The X-RAY FIELD shall not over-radiate the EFFECTIVE IMAGE RECEPTION AREA at the surface of
the X-RAY IMAGE RECEPTOR more than 2 % of the FOCAL SPOT TO IMAGE RECEPTOR DISTANCE in
one direction or at most 3 % in both directions. In the case of the X-RAY IMAGE RECEPTOR having
an active surface side length below 8 cm, the over-RADIATION shall not be larger than 1 % of the
FOCAL SPOT TO IMAGE RECEPTOR DISTANCE in one direction or at most 2 % in two directions.
5.3.2 Test
The dimensions of a rectangular X-RAY FIELD are described in terms of the length of its intercepts
on each of two orthogonal major axes in the plane of interest.
For circular X-RAY FIELD, the dimensions are described accordingly, replacing the lengths of the
intercepts with the diameter.
The maximum size available of the X-RAY FIELD is determined by examination of at least one
appropriate image from the DENTAL CBCT EQUIPMENT or use of a test instrument at the location
of the X-RAY IMAGE RECEPTOR and compared with the EFFECTIVE IMAGE RECEPTION AREA.
NOTE Examples of test verification methods can be: the presentation of an image from the DENTAL CBCT EQUIPMENT
with collimation edges visible or measurement with a device that can detect the boundary of a RADIATION field.
5.4 Reproducibility of the AIR KERMA
5.4.1 Requirement
The deviation of any individual measurement from a set from at least three measurements of
incident AIR KERMA K from their mean K shall not exceed ±5 %.
d d
– 14 – IEC 61223-3-7:2021 © IEC 2021
NOTE The measurement of incident AIR KERMA can be performed with a DIAGNOSTIC DOSEMETER shielded from
backscatter. Alternatively, the measurement of a DIAGNOSTIC DOSEMETER sensitive to backscatter can be corrected
by the appropriate factor.
The value of at installation shall serve as a BASELINE VALUE.
K
d
F
...