Amendment 1 - Medical electrical equipment - Medical image display systems - Part 1: Evaluation methods

Amendement 1 - Appareils électromédicaux - Systèmes d'imagerie médicale - Partie 1: Méthodes d'évaluation

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Status
Published
Publication Date
23-Mar-2016
Current Stage
PPUB - Publication issued
Start Date
31-May-2016
Completion Date
24-Mar-2016
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IEC 62563-1:2009/AMD1:2016 - Amendment 1 - Medical electrical equipment - Medical image display systems - Part 1: Evaluation methods
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IEC 62563-1 ®
Edition 1.0 2016-03
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
AM ENDMENT 1
AM ENDEMENT 1
Medical electrical equipment – Medical image display systems –
Part 1: Evaluation methods
Appareils électromédicaux – Systèmes d’imagerie médicale –
Partie 1: Méthodes d’évaluation

IEC 62563-1:2009-12/AMD1:2016-03(en-fr)

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IEC 62563-1 ®
Edition 1.0 2016-03
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
AM ENDMENT 1
AM ENDEMENT 1
Medical electrical equipment – Medical image display systems –

Part 1: Evaluation methods
Appareils électromédicaux – Systèmes d’imagerie médicale –

Partie 1: Méthodes d’évaluation

INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 11.040.55 ISBN 978-2-8322-3243-9

– 2 – IEC 62563-1:2009/AMD1:2016
© IEC 2016
FOREWORD
This amendment has been prepared by subcommittee 62B: Diagnostic imaging equipment, of
IEC technical committee 62: Electrical equipment in medical practice.
The text of this amendment is based on the following documents:
CDV Report on voting
62B/983/CDV 62B/995/RVC
Full information on the voting for the approval of this amendment can be found in the report
on voting indicated in the above table.
The committee has decided that the contents of this amendment and the base publication will
remain unchanged until the stability date indicated on the IEC website under
"http://webstore.iec.ch" in the data related to the specific publication. At this date, the
publication will be
• reconfirmed,
• withdrawn,
• replaced by a revised edition, or
• amended.
_____________
Introduction to Amendment 1
This amendment is published to introduce colour measurement.
Since publication of IEC 62563-1:2009, IEC 61223-2-5, Evaluation and routine testing in
medical imaging departments Part 2-5: Constancy tests – Image display devices has been
reviewed and withdrawn.
© IEC 2016
1 Scope
Replace the first sentence of the third paragraph with the following:
This standard applies to medical IMAGE DISPLAY SYSTEMS, which can display image information
on greyscale and colour IMAGE DISPLAY SYSTEMS.
Add, at the end of the third paragraph, the following new sentence:
Handheld IMAGE DISPLAY SYSTEMS might require additional or modified versions of the
procedures described in this standard.
Replace, in the fourth paragraph, the word “nor” with “or”.
3.2 Symbols
Table 1 – Overview to the definitions of physical parameters
Add, before the last row, the following new row:
a L /L Alternative safety factor. This factor
R amb min
is defined to provide consistency
with other relevant documents
(e.g. ACR–AAPM–SIIM Technical
Standard For Electronic Practice Of
Medical Imaging, Amended 2014,
Resolution 39).
Replace, in the last row, third column, “Maximum distance” by “Distance”.
7.2 Evaluation method table overview
Table 3 – List of the evaluation methods that can be used for testing medical IMAGE
DISPLAY SYSTEMS
Replace, in the fourth but last row, first column, “Chromaticity evaluation” by “Chromaticity
uniformity evaluation”.
Replace, in the third but last row, “Chromaticity evaluation of multiple displays” by
“Chromaticity evaluation across multiple displays”.
Add, at the end of Table 3, the following new row:
Greyscale chromaticity evaluation Colour meter

7.4.4 LUMINANCE evaluation of multiple displays
Replace, in the last sentence, “average” by “lowest”.
7.4.5 Chromaticity evaluation
Replace the title of subclause 7.4.5 by the following:
7.4.5 Chromaticity uniformity evaluation
Add, before the existing first sentence of the second paragraph, the following new sentence:

– 4 – IEC 62563-1:2009/AMD1:2016
© IEC 2016
The distance is calculated as the maximum for any two locations within the display screen.
7.4.6 Chromaticity evaluation of multiple displays
Replace the title of subclause 7.4.6 by the following:
7.4.6 Chromaticity evaluation across multiple displays
Add, in the second sentence of the first paragraph, after the word “measurements” the phrase
“for all IMAGE DISPLAY DEVICES”.
Delete, in the second paragraph, the words “deviation in”.
Add the following new subclause:
7.4.9 Greyscale chromaticity evaluation
With a colour meter, luminance and colour coordinates (u’, v’) are measured using TG18-LN
test patterns (TG18-LNx-i, i = 01, 02, …, 18). Measurements shall be performed without
ambient light. With only the measurements corresponding to recorded luminance values
higher than or equal to 5 cd/m , the distances in the u’,v’ plane with respect to the
measurement at full white (i.e. from TG18-LNx-18) are computed as
2 2 1/2
Δu' v' = ((u ’-u ’) + (v ’-v ’) )
i i i 18 i 18
The number of discarded measurements (luminance values less than 5 cd/m ) will vary
depending on the calibrated display function. For this reason, reporting greyscale chromaticity
results should be accompanied by the calibrated display function used for the display device
being measured.
The greyscale chromaticity is quantified as the maximum deviation in the computed
values.The greyscale chromaticity evaluation method described in 7.4.9 is applicable to both
colour and monochrome display devices.

© IEC 2016
Annex A
(informative)
Sample test reports
Table A.1 – Acceptance test sample report of a diagnostic display
Delete, in the second row, fifth line, the words “Brand Monochrome”.
Delete, in the second row, fifth line, the text “983300444 (first display of dual head)”.
Add the following new row at the end of Table A.1:
Greyscale chromaticity Colour meter Max. deviation < 0,01 OK
evaluation
Discarded measurements: (L < 5 cd/m )
NOTE This device was
LN01: L = 0,64 cd/m u’ = 0,193 6 v’ = 0,427 6
calibrated according to the
GSDF.
LN02: L = 2,03 cd/m u’ = 0,200 3 v’ = 0,449 1
LN03: L = 4,17 cd/m u’ = 0,203 9 v’ = 0,464 9
Remaining measurements:
LN04: u’ = 0,204 6 v’ = 0,469 5
LN05: u’ = 0,204 8 v’ = 0,471 5
LN06: u’ = 0,204 9 v’ = 0,472 7
LN07: u’ = 0,205 0 v’ = 0,473 5
LN08: u’ = 0,205 1 v’ = 0,474 0
LN09: u’ = 0,205 1 v’ = 0,474 3
LN10: u’ = 0,205 1 v’ = 0,474 4
LN11: u’ = 0,205 3 v’ = 0,474 3
LN12: u’ = 0,205 1 v’ = 0,474 1
LN13: u’ = 0,205 2 v’ = 0,473 8
LN14: u’ = 0,205 3 v’ = 0,473 3
LN15: u’ = 0,205 0 v’ = 0,472 4
LN16: u’ = 0,204 9 v’ = 0,471 5
LN17: u’ = 0,204 9 v’ = 0,470 8
LN18: u’ = 0,205 0 v’ = 0,470 8
Max. deviation = 0,003 6
– 6 – IEC 62563-1:2009/AMD1:2016
© IEC 2016
Table A.2 – Constancy test sample report of a diagnostic display
Delete, in the second row, fifth line, the words “Brand Monochrome”.
Delete, in the second row, fifth line, the text “983300444 (first head of dual head)”.
Add the following new row at the end of Table A.2:
Greyscale chromaticity Colour meter Max. deviation < 0,01 OK
evaluation
Discarded measurements: (L < 5 cd/m )
NOTE This device was
LN01: L = 0,64 cd/m u’ = 0,193 6 v’ = 0,427 6
calibrated according to the
GSDF.
LN02: L = 2,03 cd/m u’ = 0,200 3 v’ = 0,449 1
LN03: L = 4,17 cd/m u’ = 0,203 9 v’ = 0,464 9
Remaining measurements:
LN04: u’ = 0,204 6 v’ = 0,469 5
LN05: u’ = 0,204 8 v’ = 0,471 5
LN06: u’ = 0,204 9 v’ = 0,472 7
LN07: u’ = 0,205 0 v’ = 0,473 5
LN08: u’ = 0,205 1 v’ = 0,474 0
LN09: u’ = 0,205 1 v’ = 0,474 3
LN10: u’ = 0,205 1 v’ = 0,474 4
LN11: u’ = 0,205 3 v’ = 0,474 3
LN12: u’ = 0,205 1 v’ = 0,474 1
LN13: u’ = 0,205 2 v’ = 0,473 8
LN14: u’ = 0,205 3 v’ = 0,473 3
LN15: u’ = 0,205 0 v’ = 0,472 4
LN16: u’ = 0,204 9 v’ = 0,471 5
LN17: u’ = 0,204 9 v’ = 0,4708
LN18: u’ = 0,205 0 v’ = 0,470 8
Max. deviation = 0,003 6
Table A.3 – Acceptance test sample report of a monochrome reviewing display
Delete, in the second row, fifth line, the words “Brand Monochrome”.
Delete, in the second row, fifth line, the text “44829922 (first display of dual head)”.

Table A.4 – Constancy test sample report of a monochrome reviewing display
Delete, in the second row, fifth line, the words “Brand Monochrome”.
Delete, in the second row, fifth line, the text “44829923 (second display of dual head)”.

© IEC 2016
Table A.5 – Acceptance test sample report of a colour reviewing display
Delete, in the second row, fifth line, the words “Brand Colour”.
Delete, in the second row, fifth line, the text “56698221 (first display of dual head)”.
Add the following new row at the end of Table A.5:
Greyscale chromaticity Colour meter Max. deviation < 0,01 OK
evaluation
Discarded measurements: (L < 5 cd/m )
NOTE: This device was
LN01: L = 0,7 cd/m u’ = 0,192 7 v' = 0,458 3
calibrate
...

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