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
Current Stage
PPUB - Publication issued
Completion Date
10-Nov-2021
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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
IEC 62563-2:2021-11(en-fr)
---------------------- Page: 1 ----------------------
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---------------------- Page: 2 ----------------------
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

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 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

---------------------- Page: 4 ----------------------
IEC 62563-2:2021 © IEC:2021 – 3 –

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

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

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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preparation is entrusted to technical committees; any IEC National Committee interested in the subject dealt with

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Standardization (ISO) in accordance with conditions determined by agreement between the two organizations.

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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.

IEC 62563-2 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:
Draft Report on voting
62B/1254/FDIS 62B/1262/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: 6 ----------------------
IEC 62563-2:2021 © IEC:2021 – 5 –

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;

– informative material appearing outside of tables, such as notes, examples and references: in smaller type.

Normative text of tables is also in a smaller type;

– TERMS DEFINED IN CLAUSE 3 OF THIS INTERNATIONAL STANDARD, OR AS NOTED: SMALL CAPITALS.

A list of all parts in the IEC 62563 series, published under the general title Medical electrical

equipment – Medical image display systems, 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.
---------------------- Page: 7 ----------------------
– 6 – IEC 62563-2:2021 © IEC:2021
INTRODUCTION

This document defines ACCEPTANCE and CONSTANCY TESTS for medical image displays. It defines

TEST ITEMS for the ACCEPTANCE and CONSTANCY TESTS, as well as the performance CRITERIA and

the test frequency for each TEST ITEM, elements of the measurement method related to an image

quality parameter in an IMAGE DISPLAY SYSTEM. The evaluation methods of the TEST ITEMS are

not described in this document; rather, evaluation methods, along with prerequisites, equipment

and tools for the TEST ITEMS, are defined in IEC 62563-1.

ACCEPTANCE and CONSTANCY TESTS are performed on site at the installation facility. An

ACCEPTANCE TEST is carried out after a new IMAGE DISPLAY SYSTEM has been installed or major

modifications have been made to the existing IMAGE DISPLAY SYSTEM. Since an IMAGE DISPLAY

SYSTEM can degrade over time, CONSTANCY TESTS are carried out periodically to verify that the

performance is maintained.

This document describes appropriate TEST ITEMS and CRITERIA that are considered appropriate

as an international standard based on survey of quality control testing standards and guidelines

across the world. Although other existing standards and guidelines have been defined by other

standard organizations and can be given priority over this document, national authorities are

encouraged to adopt or harmonize to this document.
---------------------- Page: 8 ----------------------
IEC 62563-2:2021 © IEC:2021 – 7 –
MEDICAL ELECTRICAL EQUIPMENT –
MEDICAL IMAGE DISPLAY SYSTEMS –
Part 2: Acceptance and constancy tests
for medical image displays
1 Scope

This part of IEC 62563 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.

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 TR 60788:2004, Medical electrical equipment – Glossary of defined terms

IEC 62563-1:2009, Medical electrical equipment – Medical image display systems – Part 1:

Evaluation methods
IEC 62563-1:2009/AMD1:2016
3 Terms, definitions, symbols and abbreviated terms
3.1 Terms and definitions

For the purposes of this document, the terms and definitions in IEC TR 60788:2004,

IEC 62563-1:2009/AMD1:2016 and the following 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
3.1.1
ACCEPTANCE TEST

test carried out after equipment has been installed or major modifications have been made to

existing equipment to verify compliance with manufacturer's specifications or requirements

3.1.2
CONSTANCY TEST

test carried out to confirm that the functional performance of equipment meets established

CRITERIA and to enable the early recognition of changes in the properties of components of the

equipment
---------------------- Page: 9 ----------------------
– 8 – IEC 62563-2:2021 © IEC:2021
3.1.3
LUMINANCE STABILIZER

embedded functionality of IMAGE DISPLAY SYSTEM which detects LUMINANCE deviation of light

source by sensor (e.g. at bootup, degradation over time, or temperature change) caused by the

IMAGE DISPLAY SYSTEM characteristics itself or its environments and adjusts light source

LUMINANCE
automatically to stabilize display
3.1.4
CRITERIA

acceptable deviation or limit defined for each test described in this document for the results of

an ACCEPTANCE or a CONSTANCY TEST which signal a conforming performance of the equipment

tested
3.1.5
TEST ITEM

element of the measurement method related to an image quality parameter in an IMAGE DISPLAY

SYSTEM
3.1.6
RESPONSIBLE ORGANIZATION

entity accountable for the use and maintenance of a medical electrical (ME) equipment or a

medical electrical (ME) system
[SOURCE: IEC 60601-1:2005, 3.101]
3.2 Symbols

The symbols of physical parameters described in IEC 62563-1 are listed in Table 1. All

measurements referred to in Table 1 are in the centre of the IMAGE DISPLAY DEVICE; LUMINANCE

can also be measured at other locations according to the methodologies described in this

document.
Table 1 – Overview to the definitions of physical parameters
Symbol Mathematically derived Definition and explanation
L LUMINANCE generated by the ambient light on the surface of an
amb
IMAGE DISPLAY DEVICE when the IMAGE DISPLAY DEVICE is off.
L Minimum LUMINANCE generated by an IMAGE DISPLAY DEVICE at
min
DIGITAL DRIVING LEVEL (DDL) = 0 measured at the centre of the
screen. It includes VEILING GLARE specific to TEST PATTERN used
for measurement. It is measured with ambient light totally
switched off (ambient ILLUMINANCE lower than 5 lux at the face of
the IMAGE DISPLAY).
L Maximum LUMINANCE generated by an IMAGE DISPLAY DEVICE at
max
DIGITAL DRIVING LEVEL (DDL) = max. measured at the centre of the
screen. It includes VEILING GLARE specific to TEST PATTERN used
for measurement. It is measured with ambient light totally
switched off (ambient ILLUMINANCE lower than 5 lux at the face of
the IMAGE DISPLAY).
L′ L + L LUMINANCE that shall be perceived by the human eye at the
min min amb
centre of the screen at DIGITAL DRIVING LEVEL (DDL) = 0. It
contains VEILING GLARE and L .
amb
L + L LUMINANCE produced by the IMAGE DISPLAY DEVICE that shall be
max amb
max
perceived by the human eye at the maximum DIGITAL DRIVING
LEVEL (DDL) measured at the centre of the screen. It contains
VEILING GLARE and L .
amb
L’ Target LUMINANCE at maximum DIGITAL DRIVING LEVEL (DDL) being
target
the IMAGE DISPLAY DEVICE vendor recommended value or the
value used during calibration (including the ambient light
contribution).
---------------------- Page: 10 ----------------------
IEC 62563-2:2021 © IEC:2021 – 9 –
Symbol Mathematically derived Definition and explanation
ΔL’ (L' – L' )/L' [%] Percentage of difference from L’ and measured actual L’
max max target target target max
at maximum DDL.
a L /L’ Safety factor
amb min
R Diffuse reflection coefficient (provided by manufacturer with a
specific measurement method, ideally following the methods
described in [1] using a CIE standard illuminant A and an
aperture size 20 % to 30 % larger than the diameter of the
LUMINANCE meter).
r' L′ /L′ LUMINANCE ratio of an IMAGE DISPLAY DEVICE containing VEILING
max min
GLARE and ambient LUMINANCE.
E ILLUMINANCE
2 2 1/2
Δu'v' Distance between two points (u ,v ) and (u ,v ) in u'-v' space.
((u ’-u ’) + (v ’-v ’) )
1 1 2 2
1 2 1 2
3.3 Abbreviated terms
CT computed tomography
DDL digital driving level
DICOM digital imaging and communication in medicine
GSDF greyscale standard display function
LCD liquid crystal display
MR magnetic resonance
QC quality control
4 General

In IMAGE DISPLAY SYSTEMS, every individual component can limit or reduce the image quality of

the system. Therefore, it is necessary to adopt suitable measures for quality monitoring. If IMAGE

DISPLAY SYSTEMS are correctly adjusted and maintained, these devices can consistently

generate similar images.

Simple test equipment is used (LUMINANCE meter, TEST IMAGES) with PRECISION appropriate for

a test. Before a test, all test equipment shall be checked for its functioning according to the

MAGE DISPLAY DEVICE should be placed in a likely clinical position
manufacturer’s specifications. I
while performing the measurements.

According to Clause 5, IMAGE DISPLAY DEVICES shall be categorized, and ACCEPTANCE TEST and

CONSTANCY TEST shall be performed respectively. ACCEPTANCE TEST shall be performed after a

new IMAGE DISPLAY SYSTEMS installation or major modification of an existing IMAGE DISPLAY

SYSTEM. The CONSTANCY TEST shall be performed periodically to confirm that the performance

is maintained.

The results of ACCEPTANCE and CONSTANCY TESTING shall be recorded. If the test did not meet

the CRITERIA, immediate response (e.g., as recommended by the IMAGE DISPLAY DEVICE

manufacturer) such as repair service, re-calibration, or replace of IMAGE DISPLAY DEVICE (s) shall

be performed. It is optimal to manage systems properly and not fail the tests. If tests fail,

analysis of results or more frequent testing is advisable. Testing conditions, test instruments,

TEST PATTERNS and evaluation methods are defined in IEC 62563-1. Annex A shows a sample

ACCEPTANCE and CONSTANCY TEST report.
___________
Numbers in square brackets refer to the Bibliography.
---------------------- Page: 11 ----------------------
– 10 – IEC 62563-2:2021 © IEC:2021
5 Categories

IMAGE DISPLAY DEVICES shall be categorized in three categories: I, II and III. Category I is further

categorized in 2 subcategories: I-A and I-B.
The following application categories and subcategories are defined.

Category I-A: IMAGE DISPLAY DEVICE which has at least a 2 048 × 2 048 pixel array size and

a GSDF LUMINANCE response. This category is recommended if consistent

visibility of subtle contrast and finest detail is required for accurate diagnosis.

Application examples include mammography and digital breast
tomosynthesis.

Category I-B: IMAGE DISPLAY DEVICE which has at least a 1 024 × 1 024 pixel array size and

a GSDF LUMINANCE response. This category is recommended if consistent

visibility of low contrast and fine detail is required for the clinical application.

Application examples include images such as chest X-ray, CT and MR, and
breast biopsy.

Category II: IMAGE DISPLAY DEVICE which has a GSDF LUMINANCE response. This category

is recommended if consistent visibility of contrast is required for the clinical
image viewing application. Application examples include acquisition and
viewing workstations, ultrasound, angiography and fluoroscopy.

Category III: IMAGE DISPLAY DEVICE which has a defined LUMINANCE response function other

than GSDF. This category is recommended if quality assured visibility of
contrast is required for the clinical image viewing application. Application
examples include acquisition and viewing workstations, ultrasound,
angiography and fluoroscopy.

The application examples given for each of these categories and subcategories are not

normative. Before performing an ACCEPTANCE TEST, clinical institutions or physicians shall

decide in which category and subcategory a specific IMAGE DISPLAY DEVICE is categorized taking

possible regionally applicable regulations into account and the IMAGE DISPLAY DEVICE

manufacturer’s information.

If an IMAGE DISPLAY DEVICE is used for multiple applications, its application category

...

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