IEC 61223-3-4:2000
Current
The latest, up-to-date edition.
Evaluation and routine testing in medical imaging departments - Part 3-4: Acceptance tests - Imaging performance of dental X-ray equipment
Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users
English, Spanish, Castilian
21-03-2000
FOREWORD
INTRODUCTION
1 Scope and object
1.1 Scope
1.2 Object
2 Normative references
3 Terminology
3.1 Degree of requirements
3.2 Use of terms
3.3 Defined terms
4 General aspects of ACCEPTANCE TESTS
4.1 General conditions to be considered in test
procedures
4.2 Documents and data for the tests
4.3 Test conditions
4.4 Scope of tests
4.5 Test equipment including PHANTOMS and TEST
DEVICES
4.6 Evaluating the test results
5 Test methods for dental X-RAY EQUIPMENT with intra-oral
X-RAY IMAGE RECEPTOR
5.1 Visual and functional tests
5.2 *X-RAY TUBE VOLTAGE
5.3 *TOTAL FILTRATION
5.4 *FOCAL SPOT of the X-RAY TUBE
5.5 Limitation and alignment of the X-RAY BEAM
5.6 FOCAL SPOT TO SKIN DISTANCE
5.7 *Reproducibility of RADIATION OUTPUT
5.8 LINE PAIR RESOLUTION
5.9 LOW CONTRAST RESOLUTION
6 Test methods for dental panoramic X-RAY EQUIPMENT with
extra-oral X-RAY IMAGE RECEPTOR
6.1 Visual and functional tests
6.2 X-RAY TUBE VOLTAGE
6.3 TOTAL FILTRATION
6.4 FOCAL SPOT of the X-RAY TUBE
6.5 Limitation and alignment of the X-RAY BEAM
6.6 FOCAL SPOT TO SKIN DISTANCE
6.7 Reproducibility of RADIATION OUTPUT
6.8 LINE PAIR RESOLUTION
6.9 LOW CONTRAST RESOLUTION
6.10 RADIOGRAPHIC FILM cassettes with INTENSIFYING
SCREENS
6.11 Image homogeneity
6.12 Indicators for patients' positioning
6.13 Panoramic layer
7 Test methods for dental cephalometric X-RAY EQUIPMENT
with extra-oral X-RAY IMAGE RECEPTOR
7.1 Visual and functional tests
7.2 X-RAY TUBE VOLTAGE
7.3 TOTAL FILTRATION
7.4 FOCAL SPOT of the X-RAY TUBE
7.5 Limitation and alignment of the X-RAY BEAM
7.6 FOCAL SPOT TO SKIN DISTANCE
7.7 Reproducibility of RADIATION OUTPUT
7.8 LINE PAIR RESOLUTION
7.9 LOW CONTRAST RESOLUTION
7.10 RADIOGRAPHIC FILM cassettes with INTENSIFYING
SCREENS
8 Test report and statement of compliance
Annex A (normative) Terminology - Index of defined terms
Annex B (informative) Examples of requirements (accuracy,
tolerances, discrepancies according
to actual IEC standards or state of
the art)
Annex C (informative) ACCEPTANCE TEST for processing of
non-screen dental X-ray films
(non-screen film)
Bibliography
Figure 1 - Dental X-RAY EQUIPMENT with intra-oral X-RAY
IMAGE RECEPTOR measuring arrangement for AIR KERMA
and resolution
Figure 2 - Dental X-RAY EQUIPMENT and intra-oral X-RAY IMAGE
RECEPTOR measuring arrangement for AIR KERMA and
resolution
Figure 3 - Dental Panoramic X-RAY EQUIPMENT with extra-oral
X-RAY IMAGE RECEPTOR measuring arrangement for AIR
KERMA and resolution
Figure 4 - Example of a dental panoramic X-RAY EQUIPMENT with
extra-oral digital X-RAY IMAGE RECEPTOR measuring
arrangement for AIR KERMA, resolution, image
homogeneity and panoramic layer
Figure 5 - Example of a cephalometric X-RAY EQUIPMENT with
extra-oral X-RAY IMAGE RECEPTOR measuring
arrangement for AIR KERMA and resolution
Figure 6 - Dental PHANTOM (example)
Figure 7 - Dental PHANTOM for digital image acquisition or
processing parts (example)
Table B.1 - Typical values of FOCAL SPOT dimensions for
NOMINAL FOCAL SPOT VALUES
Applies to the performance of the acceptance test on dental X-ray equipment with intra-oral X-ray image receptor and dental X-ray equipment with extra-oral X-ray image receptor (for example, dental panoramic X-ray equipment or cephalometric X-ray equipment). Defines: - the essential parameters which describe the performance of the above-mentioned dental X-ray equipment with regard to imaging properties and patient dose; - methods of testing and wether measured quantities related to those parameters comply with the specified tolerances.
Committee |
TC 62/SC 62B
|
DevelopmentNote |
Also numbered as BS EN 61223-3.4. (01/2006) Stability Date: 2018. (09/2017)
|
DocumentType |
Standard
|
Pages |
35
|
PublisherName |
International Electrotechnical Committee
|
Status |
Current
|
Standards | Relationship |
NEN EN IEC 61223-3-4 : 2000 | Identical |
I.S. EN 61223-3-4:2000 | Identical |
PN EN 61223-3-4 : 2002 | Identical |
AS/NZS 4184.3.4:2002 | Identical |
SN EN 61223-3-4 : 2000 | Identical |
EN 61223-3-4 : 2000 | Identical |
DIN EN 61223-3-4:2001-10 | Identical |
GOST R IEC 61223-3-4 : 2001 | Identical |
NF EN 61223-3-4 : 2005 | Identical |
JIS Z 4752-3-4:2005 | Identical |
CEI EN 61223-3-4 : 2001 | Identical |
UNE-EN 61223-3-4:2002 | Identical |
BS EN 61223-3-2:2008 | Evaluation and routine testing in medical imaging departments Acceptance tests. Imaging performance of mammographic X-ray equipment |
IEC TR 60788:2004 | Medical electrical equipment - Glossary of defined terms |
ISO 16142-1:2016 | Medical devices — Recognized essential principles of safety and performance of medical devices — Part 1: General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards |
BS ISO 16142-1:2016 | Medical devices. Recognized essential principles of safety and performance of medical devices General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards |
I.S. EN 61223-3-2:2008 | EVALUATION AND ROUTINE TESTING IN MEDICAL IMAGING DEPARTMENTS - PART 3-2: ACCEPTANCE TESTS - IMAGING PERFORMANCE OF MAMMOGRAPHIC X-RAY EQUIPMENT |
IEC 61223-3-2:2007 | Evaluation and routine testing in medical imaging departments - Part 3-2: Acceptance tests - Imaging performance of mammographic X-ray equipment |
PD IEC TR 60788:2004 | Medical electrical equipment. Glossary of defined terms |
DIN 6868-161:2013-01 | Image quality assurance in diagnostic X-ray departments - Part 161: RoeV acceptance testing of dental radiographic equipment for digital cone-beam computed tomography |
EN 61223-3-2:2008 | Evaluation and routine testing in medical imaging departments - Part 3-2: Acceptance tests - Imaging performance of mammographic X-ray equipment |
IEC 60336:2005 | Medical electrical equipment - X-ray tube assemblies for medical diagnosis - Characteristics of focal spots |
IEC 60417-1:2002 | Graphical symbols for use on equipment - Part 1: Overview and application |
IEC 60601-1:2005+AMD1:2012 CSV | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance |
IEC 60522:1999 | Determination of the permanent filtration of X-ray tube assemblies |
IEC TR 60788:2004 | Medical electrical equipment - Glossary of defined terms |
ISO 2092:1981 | Light metals and their alloys Code of designation based on chemical symbols |
IEC 60601-2-28:2017 | Medical electrical equipment - Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis |
IEC TR 60878:2015 | Graphical symbols for electrical equipment in medical practice |
IEC 60417-2:1998 | Graphical symbols for use on equipment - Part 2: Symbol originals |
IEC 61267:2005 | Medical diagnostic X-ray equipment - Radiation conditions for use in the determination of characteristics |
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