prEN IEC 63483:2025

SLOVENSKI STANDARD
01-september-2025
Metode za ocenjevanje zmogljivosti spektralnega slikanja pri računalniški
tomografiji
Methods for spectral imaging performance evaluation of computed tomography
Ta slovenski standard je istoveten z: prEN IEC 63483:2025
ICS:
11.040.50 Radiografska oprema Radiographic equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

62B/1387/CDV
COMMITTEE DRAFT FOR VOTE (CDV)
PROJECT NUMBER:
IEC 63483 ED1
DATE OF CIRCULATION: CLOSING DATE FOR VOTING:
2025-07-25 2025-10-17
SUPERSEDES DOCUMENTS:
62B/1359/CD, 62B/1377A/CC
IEC SC 62B : MEDICAL IMAGING EQUIPMENT, SOFTWARE, AND SYSTEMS
SECRETARIAT: SECRETARY:
Germany Ms Regina Geierhofer
OF INTEREST TO THE FOLLOWING COMMITTEES: HORIZONTAL FUNCTION(S):

ASPECTS CONCERNED:
Safety
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TITLE:
Methods for spectral imaging performance evaluation of computed tomography

PROPOSED STABILITY DATE: 2030
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IEC 63483 ED1 © DRAFT © IEC:2025 62B/1387/CDV
IEC 2025
Link to Committee Draft for Vote (CDV) online document:
https://osd.iec.ch/#/editor/archive/1f1894c1-dc0c-a924-e063-dd13000a3c2c/en/CCDV/1

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IEC 63483 ED1 © DRAFT © IEC:2025 62B/1387/CDV
IEC 2025
CONTENTS
CONTENTS . 1
FOREWORD . 2
Introduction. 4
1 Scope . 5
2 Normative references . 5
3 Terms and definitions . 6
3.1 Terms defined in this standard . 6
3.2 Terms defined in other standards . 7
4 General consideration of spectral imaging performance evaluation . 9
4.1 Typical conditions of operation for CT spectral imaging (3.1.1) . 9
4.2 Performance evaluation methodologies for CT spectral imaging (3.1.1) . 9
4.3 Dosimetry of spectral imaging . 10
4.4 Technical considerations for proper use for the evaluation methods . 10
5 Applicability of conventional CT imaging performance metrics for spectral imaging. 10
5.1 Conventional CT performance evaluation metrics . 10
5.2 Applicability to different types of spectral images (3.1.2) . 10
6 CT spectral imaging (3.1.1) performance evaluation . 11
6.1 General . 11
6.2 Phantoms for spectral imaging performance evaluation. 11
6.2.1 Overall phantom characteristics . 11
6.2.2 Test objects (3.2.9) . 12
6.2.3 Phantom size selection and positioning . 12
6.3 Evaluation of spectral imaging performance . 13
6.3.1 Evaluation of virtual non-contrast images (3.1.5) . 13
6.3.2 CT number (3.2.3) accuracy in virtual monoenergetic images (3.1.4) . 13
6.3.3 Accuracy of iodine concentration measurements . 14
6.3.4 Accuracy of electron density measurements . 14
Annex A (informative) Calculation of CT number (3.2.3) value in virtual monoenergetic
images (3.1.4) . 16
A.1 Calculation of mass attenuation coefficient . 16
A.2 CT number (3.2.3) in virtual monoenergetic images (3.1.4) . 16
Annex B (informative) The correlations between IEC standard and other works . 18
B.1 General . 18
B.2 DICOM Supplement 188 . 18
B.3 YY.T 1766.3 . 18
B.4 AAPM TG291 and AAPM TG299 . 19
Annex C (informative) Limitations of phantom measurements . 20
Annex D (informative) Spectral image (3.1.2) type chosen in this document . 21
Bibliography . 22

Table 1 – Applicability of conventional CT imaging performance evaluation metrics on
CT spectral image (3.1.2) types . 11

IEC 63483 ED1 © DRAFT © IEC:2025 62B/1387/CDV
IEC 2025
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
Methods for spectral imaging performance evaluation of computed
tomography
FOREWORD
1) The International Electrotechnical Commission (IEC) is a worldwide organization for
standardization comprising all national electrotechnical committees (IEC National Committees).
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the use of (a) patent(s). IEC takes no position concerning the evidence, validity or applicability
of any claimed patent rights in respect thereof. As of the date of publication of this document,
IEC [had/had not] received notice of (a) patent(s), which may be required to implement this
IEC 63483 ED1 © DRAFT © IEC:2025 62B/1387/CDV
IEC 2025
document. However, implementers are cautioned that this may not represent the latest
information, which may be obtained from the patent database available at https://patents.iec.ch.
IEC shall not be held responsible for identifying any or all such patent rights.
IEC 6XXXX has been prepared by subcommittee XX: TITLE, of IEC technical committee XX:
TITLE. It is an International Standard.
This XXX edition cancels and replaces the XXX edition published in [publication_date],
Amendment 1:[publication_date] and Amendment 2:[publication_date]. This edition constitutes
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This edition includes the following significant technical changes with respect to the previous
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a) .;
The text of this International Standard is based on the following documents:
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The language used for the development of this International Standard is English [change
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IEC 63483 ED1 © DRAFT © IEC:2025 62B/1387/CDV
IEC 2025
Introduction
The purpose of the document is to provide a set of standardized methods and metrics for the
evaluation of CT spectral imaging (3.1.1).
Main content of this document includes:
– Key definitions of CT spectral imaging (3.1.1) and also spectral image (3.1.2) types
differentiated as conventional CT
– Applicability and scenarios of conventional imaging performance evaluation metrics and
methodology in CT spectral imaging (3.1.1)
– Dedicated performance evaluation metrics, methodologies and applicable phantom
specifications for corresponding image types from CT spectral imaging (3.1.1)
– Necessary notes/informative annex about CT spectral imaging (3.1.1) technology and
references
IEC 63483 ED1 © DRAFT © IEC:2025 62B/1387/CDV
IEC 2025
1 Scope
This document applies to spectral image (3.1.2) types based on data provided by a CT scanner
(3.2.2) that confirms to IEC 60601-2-44 . The spectral images (3.1.2) can be generated either
on the CT scanner (3.2.2) or with separate software.
The purpose of this standard is
...