IEC 62563-2:2021

Medical electrical equipment - Medical image display systems - Part 2: Acceptance and constancy tests for medical image displays

IEC 62563-2:2021 establishes the performance CRITERIA and test frequencies for the ACCEPTANCE TESTS and CONSTANCY TESTS. The evaluation methods are defined in IEC 62563-1. The scope of this document is directed to practical tests that can be visually evaluated or measured using basic test equipment. This document applies to medical IMAGE DISPLAY SYSTEMS, which can display monochrome image information in the form of greyscale values on colour and greyscale IMAGE DISPLAY SYSTEMS. This document does not apply to information displays and to displays used solely for control of technical settings of all medical information.

Appareils électromédicaux - Systèmes d’imagerie médicale - Partie 2 : Essais d’acceptation et de constance des systèmes d’imagerie médicale

L'IEC 62563-2:2021 établit les CRITÈRES de performance et les fréquences d’essai pour les ESSAIS D’ACCEPTATION et les ESSAIS DE CONSTANCE. Les méthodes d’évaluation sont définies dans l’IEC 62563-1. Le présent document est destiné aux essais pratiques qui peuvent faire l’objet d’une évaluation ou d’un mesurage visuels en utilisant un matériel d’essai de base. Le présent document s’applique aux SYSTÈMES D’IMAGERIE médicale qui peuvent afficher des informations d’images monochromes sous forme de valeurs à échelle des gris sur les SYSTÈMES D’IMAGERIE à échelle des gris et couleur. Le présent document ne s’applique pas aux écrans d’affichage d’informations et aux écrans d’affichage utilisés uniquement pour le contrôle des configurations techniques de toutes les informations médicales.

General Information

• Status: Published
• Publication Date: 09-Nov-2021
• ICS: 11.040.55 - Diagnostic equipment
• ICS: 31.120 - Electronic display devices
• Technical Committee: SC 62B - Medical imaging equipment, software, and systems
• Drafting Committee: WG 51 - TC 62/SC 62B/WG 51
• Current Stage: PPUB - Publication issued
• Start Date: 19-Nov-2021
• Completion Date: 10-Nov-2021

Standards Content (Sample)

IEC 62563-2 ®
Edition 1.0 2021-11
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical electrical equipment – Medical image display systems –
Part 2: Acceptance and constancy tests for medical image displays

Appareils électromédicaux – Systèmes d’imagerie médicale –
Partie 2: Essais d’acceptation et de constance des systèmes d’imagerie
médicale
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IEC 62563-2 ®
Edition 1.0 2021-11
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical electrical equipment – Medical image display systems –

Part 2: Acceptance and constancy tests for medical image displays

Appareils électromédicaux – Systèmes d’imagerie médicale –

Partie 2: Essais d’acceptation et de constance des systèmes d’imagerie

médicale
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 11.040.55; 31.120 ISBN 978-2-8322-1039-8

– 2 – IEC 62563-2:2021 © IEC:2021
CONTENTS
FOREWORD . 4
INTRODUCTION . 6
1 Scope . 7
2 Normative references . 7
3 Terms, definitions, symbols and abbreviated terms . 7
3.1 Terms and definitions . 7
3.2 Symbols . 8
3.3 Abbreviated terms . 9
4 General . 9
5 Categories . 10
6 ACCEPTANCE TEST . 11
6.1 General . 11
6.2 When to test . 11
6.3 Evaluation items and CRITERIA for ACCEPTANCE TEST . 11
6.4 ACCEPTANCE TEST result . 15
7 CONSTANCY TEST . 16
7.1 General . 16
7.2 Frequency of CONSTANCY TEST . 16
7.3 Evaluation items and CRITERIA . 16
7.4 CONSTANCY TEST result . 16
Annex A (informative) Sample test reports . 17
A.1 General . 17
A.2 ACCEPTANCE TEST sample report of a category I-A diagnostic display . 17
A.2.1 General information . 17
A.2.2 Displays . 17
A.2.3 Test results. 17
A.3 CONSTANCY TEST sample report of a category I-A diagnostic display . 21
A.3.1 General information . 21
A.3.2 Displays . 21
A.3.3 Test results. 21
Annex B (informative) Ambient light control . 24
Annex C (informative) Evaluation CRITERIA examples of clinical images . 29
C.1 General . 29
C.2 Chest image . 29
Bibliography . 34
Index of defined terms . 35

Figure B.1 – L and E relationship when r' ≥ 250 . 24
min
Figure B.2 – Possible deviation range of E conforming to GSDF ±10 % . 26
Figure B.3 (1 of 2) – Example charts of possible deviation ranges of ILLUMINANCE (E),
calibrated at four different ambient LUMINANCE (L ) levels (shown at right) . 27
amb
Figure B.3 (2 of 2) – Example charts of possible deviation ranges of ILLUMINANCE (E),
calibrated at four different ambient LUMINANCE (L ) levels (shown at right) . 28
amb
Figure C.1 – Chest clinical image . 29

Figure C.2 – Visually sharp reproduction of the vessel from hilum to peripheral area . 30
Figure C.3 – Visibility of vessels under retro-cardiac area and under diaphragm . 30
Figure C.4 – Visually sharp reproduction of trachea and proximal bronchia . 31
Figure C.5 – Distinct reproduction of frame of spine, lateral protrusion, and spinous
process . 31
Figure C.6 – Distinct reproduction of edge of heart . 31
Figure C.7 – Excellent graininess (no artefacts or significant noise) of thorax and

underarm soft tissue . 32
Figure C.8 – Distinct reproduction of the border of rib and peripheral lung, border of
lower edge of lung . 33

Table 1 – Overview to the definitions of physical parameters . 8
Table 2 – Tests and TEST ITEMs for quantitative evaluation . 11
Table 3 – Tests and TEST ITEMs for visual evaluation . 13
Table 4 – Quantitative acceptance and CONSTANCY TESTs . 14
Table 5 – Visual acceptance and CONSTANCY TESTs . 15

– 4 – IEC 62563-2:2021 © IEC:2021
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL ELECTRICAL EQUIPMENT –
MEDICAL IMAGE DISPLAY SYSTEMS –

Part 2: Acceptance and constancy tests
for medical image displays
FOREWORD
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