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 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.
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.
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.

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.

General Information

Status
Published
Publication Date
06-Dec-2021
Current Stage
PPUB - Publication issued
Completion Date
07-Dec-2021
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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
IEC 61223-3-7:2021-12(en-fr)
---------------------- Page: 1 ----------------------
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---------------------- Page: 2 ----------------------
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
---------------------- Page: 3 ----------------------
– 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

---------------------- Page: 4 ----------------------
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

---------------------- Page: 5 ----------------------
– 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

---------------------- Page: 6 ----------------------
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

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8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is

indispensable for the correct application of this publication.

9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of patent

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.
---------------------- Page: 7 ----------------------
– 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.
---------------------- Page: 8 ----------------------
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.
---------------------- Page: 9 ----------------------
– 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 th
...

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