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)

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 EQUIPMENTmeets 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: 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)

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
14-Feb-2022
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
11-Feb-2022
Due Date
18-Apr-2022
Completion Date
15-Feb-2022

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SLOVENSKI STANDARD
SIST EN IEC 61223-3-7:2022
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
SIST EN IEC 61223-3-7:2022 en

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN IEC 61223-3-7:2022
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SIST EN IEC 61223-3-7:2022
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
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SIST EN IEC 61223-3-7:2022
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)
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SIST EN IEC 61223-3-7:2022
EN IEC 61223-3-7:2022 (E)
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
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SIST EN IEC 61223-3-7:2022
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SIST EN IEC 61223-3-7:2022
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

Warning! Make sure that you obtained this publication from an authorized distributor.

Attention! Veuillez vous assurer que vous avez obtenu cette publication via un distributeur agréé.

® Registered trademark of the International Electrotechnical Commission
Marque déposée de la Commission Electrotechnique Internationale
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SIST EN IEC 61223-3-7:2022
– 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

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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

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SIST EN IEC 61223-3-7:2022
– 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

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SIST EN IEC 61223-3-7:2022
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

1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising

all national electrotechnical committees (IEC National Committees). The object of IEC is to promote international

co-operation on all questions concerning standardization in the electrical and electronic fields. To this end and

in addition to other activities, IEC publishes International Standards, Technical Specifications, Technical Reports,

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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.
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SIST EN IEC 61223-3-7:2022
– 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.

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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

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• reconfirmed,
• withdrawn,
• replaced by a revised edition, or
• amended.

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contents. Users should therefore print this document using a colour printer.
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SIST EN IEC 61223-3-7:2022
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, regulati
...

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