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BS EN IEC 62563-2:2021:2022 Edition

$167.15

Medical electrical equipment. Medical image display systems – Acceptance and constancy tests for medical image displays

Published By Publication Date Number of Pages
BSI 2022 40
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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.

PDF Catalog

PDF Pages PDF Title
2 undefined
5 Annex ZA (normative)Normative references to international publicationswith their corresponding European publications
6 English
CONTENTS
8 FOREWORD
10 INTRODUCTION
11 1 Scope
2 Normative references
3 Terms, definitions, symbols and abbreviated terms
3.1 Terms and definitions
12 3.2 Symbols
Tables
Table 1 ā€“ Overview to the definitions of physical parameters
13 3.3 Abbreviated terms
4 General
14 5 Categories
15 6 ACCEPTANCE TEST
6.1 General
6.2 When to test
6.3 Evaluation items and criteria for acceptance test
Table 2 ā€“ Tests and test items for quantitative evaluation
17 Table 3 ā€“ Tests and test items for visual evaluation
18 Table 4 ā€“ Quantitative acceptance and constancy tests
19 6.4 Acceptance test result
Table 5 ā€“ Visual acceptance and constancy tests
20 7 CONSTANCY TEST
7.1 General
7.2 Frequency of constancy test
7.3 Evaluation items and criteria
7.4 Constancy test result
21 Annex A (informative)Sample test reports
A.1 General
A.2 Acceptance test sample report of a category I-A diagnostic display
A.2.1 General information
A.2.2 Displays
A.2.3 Test results
25 A.3 Constancy test sample report of a category I-A diagnostic display
A.3.1 General information
A.3.2 Displays
A.3.3 Test results
28 Annex B (informative)Ambient light control
Figures
Figure B.1 ā€“ Lmin and E relationship when r’ ā‰„ 250
30 Figure B.2 ā€“ Possible deviation range of E conforming to GSDF Ā±10 %
31 Figure B.3 (1 of 2) ā€“ Example charts of possible deviation ranges of illuminance (E), calibrated at four different ambient luminance (Lamb) levels (shown at right)
32 Figure B.3 (2 of 2) ā€“ Example charts of possible deviation ranges of ILLUMINANCE (E ),calibrated at four different ambient LUMINANCE (L amb) levels (shown at right)
33 Annex C (informative)Evaluation criteria examples of clinical images
C.1 General
C.2 Chest image
Figure C.1 ā€“ Chest clinical image
34 Figure C.2 ā€“ Visually sharp reproduction of the vessel from hilum to peripheral area
Figure C.3 ā€“ Visibility of vessels under retro-cardiac area and under diaphragm
35 Figure C.4 ā€“ Visually sharp reproduction of trachea and proximal bronchia
Figure C.5 ā€“ Distinct reproduction of frame of spine, lateral protrusion, and spinous process
Figure C.6 ā€“ Distinct reproduction of edge of heart
36 Figure C.7 ā€“ Excellent graininess (no artefacts or significant noise) of thorax and underarm soft tissue
37 Figure C.8 ā€“ Distinct reproduction of the border of rib and peripheral lung, border of lower edge of lung
38 Bibliography
39 Index of defined terms
BS EN IEC 62563-2:2021
$167.15