Balázs Vince Nagy
Laboratório da Visão – IP/USP
Relator - ABNT CE26 GT51 - IEC TC62 MT51
MEDICAL ELECTRICAL EQUIPMENT
MEDICAL IMAGE DISPLAY SYSTEMS
Part 1: Evaluation methods
This International Standard provides guideline on
evaluation methods for testing IMAGE DISPLAY
SYSTEMS used in MEDICAL ELECTRICAL
EQUIPMENT and medical electrical systems for
diagnostic imaging.
Scope
This part of IEC 62563 describes the
SYSTEMS.
evaluation methods for testing medical IMAGE DISPLAY
The scope of this International Standard is directed to practical tests that can be visually evaluated or
measured using basic test equipment. More advanced or more quantitative measurements
can be performed on these devices, but these are beyond the scope of this document.
This standard 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 (e.g.
CATHODE RAY TUBE (CRT) monitors, FLAT PANEL DISPLAYS, PROJECTION SYSTEM). This standard
applies to medical IMAGE DISPLAY SYSTEMS used for diagnostic (interpretation of medical images toward
rendering clinical diagnosis) or viewing (viewing medical images for medical purposes other than for
providing a medical interpretation) purposes and therefore having specific requirements in terms of image
quality. Head mounted IMAGE DISPLAY SYSTEMS and IMAGE DISPLAY SYSTEMS used for confirming
positioning and for operation of the system are not covered by this standard.
It is not in the scope of this standard
tests nor the frequencies of constancy tests.
to define the requirements of acceptance and constancy
Terms and definitions EXAMPLES
brightness: LUMINANCE as perceived by the
human visual system
flat panel display: IMAGE DISPLAY DEVICE that is
flat and thin
spatial resolution: measure of the ability of an
IMAGE DISPLAY SYSTEM to distinguish spatial
features of interest within an image
REF to other norms ie. CIE, etc.
Luminance Ratio
Lwhite + Lambient
C
Lblack + Lambient
Lambient is the reflected ambient
luminance from the display:
C
Lambient = Illuminance * Rd
Rd = diffuse reflection coefficient
Equipment and tools
LUMINANCE meter
ILLUMINANCE meter
Colour meter
Spectroradiometer
Digital Imaging and Communications in
Medicine
Company support for IEC62563-1
Product validation & testing
Production
MediCal QAWeb
Service & Support
Limiting values and test freuencies are not defined!
Refer to nationally defined values or other standards such as
AAPM TG18, ACR, JESRA, VESA FPDM or DIN 6868-57.
Members Present:
FDA (US)
LMTI (China)
NIST (US)
Sahlgrensha (Sweden)
HFHS (US)
USP (Brazil)
BARCO (Belgium)
Totoku (Japan)
Duke U (US)
EIZO (Japan)
• Tarefas principais do grupo:
Revisão da norma IEC 62563 e inclusão de critérios e incluir
metodologia/instrumentação/etc. para avaliar displays com cores
• Vai criar duas emendas em topicos ainda para especificar:
Handheld display devices
Questões temporais em tomosynthesis e cross-sectional imaging
3D
Grey point D65
• Referência às outras normas, grupos de trabalho e desejável (ISO, ICC, CIE,
AAPM, etc.)
• Precisaremos de valores mínimos exatos na nova norma? Nem todas as
normas do IEC possuem. Para alguns países seria melhor adaptar a norma em
si ou definir os valores mínimos delas?
• Reuniões futuras:
2012 – 23/24 Outubro – Brussels/Belgica
2013 – primavera - China
2013 – outono – Duke University, EUA
2014 – primavera – Europa ou Americas (Brasil?)
2014 – outono – Europa ou Asia
Balázs Vince Nagy - Relator - IP-USP
Marcio Bottaro - IEE-USP – coordenador CE26
José Gil Oliveira - IEE-USP
Rinaldo C. Pinto - IEE-USP
Celso Pinto Saraiva - CPqD
Antonio Umberto Pedrazzani Junior - CPqD
Tarefas:
Atividade no nivel nacional e dar feedback para o comite
internacional atraves do relator
Revisar a norma ja existente e contribuir nas emendas
Internalizar a norma IEC para norma NBR para avaliação
de displays medicos no Brasil!
Definir valores de aceitação para os testes aplicados e
definir a frequencia de testes baseado na norma IEC
62563-1:2009 e outras normas internacionais e resultados
nacionais
Participar nos atividades organizados pelo grupo
internacional
Goal for 'gray tracking'
What tolerances to set on color over the luminance range (CIE u',v')
We gather performance data on:
1. Reference sensors of display vendors
2. Characterization with affordable colorimeters used in the field
Proposal for measurements:
Send the display to all participants for gray tracking measurements
Describe the exact sequence for the characterization measurements
Proposal for display:
Display is a medical diagnostic 3MP color display - CCFL (Barco MDNC3121)
Proposal for publishing information:
Every participant measures the display according to the protocol, using his own reference device (spectroradiometer) and
sends the results to FDA
Every participant is encouraged to collect additional measurements with colorimeters that are available and send the
results to FDA
FDA collects and processes all reference measurements (and colorimeter measurements) from the
participants
FDA shows results to the group in an anomyzed way (for reference meter
and colorimeters)
Together with AAPM TG1-96
Verify repeatability on levels 0, 120, 255 by
measuring each level 5 times
(fill out measurements in Repeatability
worksheet)
Check that Y variation < 10% for level 0
Check that Y variation < 2% for levels
120 and 255
Check that CIE u', v' variation <= 0.005
for level 0
Check that CIE u', v' variation <= 0.001
for levels 120 and 255
To define expected uncertainty values of
the different measurement equipment!
May – Sept 2012
1
FDA - USA
2
NIST - USA
3
EIZO - JP
4
TOTOKU - JP
5
NEC - JP
6
BARCO - BE
7
CPqD/USP-IEE BRASIL
8
FDA - USA
HIGH-END
MEDIUM
LOW-END
Balázs Vince Nagy
IP/USP
[email protected]