I.S. EN 61223-3-2:2008
Current
The latest, up-to-date edition.
EVALUATION AND ROUTINE TESTING IN MEDICAL IMAGING DEPARTMENTS - PART 3-2: ACCEPTANCE TESTS - IMAGING PERFORMANCE OF MAMMOGRAPHIC X-RAY EQUIPMENT
Hardcopy , PDF
English
01-01-2008
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FOREWORD
INTRODUCTION
1 Scope
2 Normative references
3 Terms and definitions
4 General aspects of the ACCEPTANCE TEST
4.1 Levels of compliance
4.2 General conditions in test procedures
4.3 Documents and data for the tests
4.4 Test conditions
4.5 Scope of tests
4.6 Test EQUIPMENT
4.7 Evaluating the test results
5 Test methods for mammographic X-RAY EQUIPMENT
5.1 Initial test and inventory
5.2 X-RAY TUBE VOLTAGE
5.3 HALF VALUE LAYER (HVL)
5.4 NOMINAL FOCAL SPOT VALUE
5.5 X-RAY FIELD limitation and beam alignment
5.6 Radiation output
5.7 AUTOMATIC EXPOSURE CONTROL (AEC)
5.8 Reproducibility of the AIR KERMA
5.9 ATTENUATION RATIO of material between the upper surface of
the PATIENT SUPPORT and the IMAGE RECEPTION PLANE
5.10 Breast COMPRESSION DEVICE
5.11 Uniformity
5.12 Dynamic range of mammographic X-RAY EQUIPMENT using digital
X-ray image receptors, including storage phosphor systems
5.13 Spatial resolution
5.14 LOW CONTRAST DETECTABILITY
5.15 Entrance surface AIR KERMA
5.16 Biopsy needle positioning accuracy of MAMMOGRAPHIC
STEREOTACTIC DEVICES
6 Baseline values for CONSTANCY TESTS
7 Test report and statement of compliance
Annex A (informative) TEST DEVICES and arrangements for testing
the automatic exposure control system with a digital X-RAY
IMAGE RECEPTOR
Annex B (informative) TEST DEVICE for testing the dynamic range
of systems with a digital X-RAY IMAGE RECEPTOR
Annex C (informative) Test methods for screen-film X-ray image
receptor
Annex D (informative) Test methods for storage phosphor system
Annex E (informative) Example of a method for the determination
of the AVERAGE GLANDULAR DOSE
Annex F (informative) Example of TEST DEVICES and arrangements
for testing the system contrast transfer function for
systems with a digital X-RAY IMAGE RECEPTOR
Annex G (informative) LOW CONTRAST DETECTABILITY test for
mammographic X-RAY EQUIPMENT using an integrated digital
X-RAY IMAGE RECEPTOR or storage phosphor plates
Annex H (informative) Example of a mammographic stereotactic
TEST DEVICE
Annex I (normative) Set-up for HALF-VALUE LAYER measurements
Annex J (informative) Definition of the ROIs for testing lag
effects
Annex K (informative) ARTIFACTS and other non-uniformities
Annex L (informative) Cross reference and history
Annex ZA (normative) Normative references to international
publications with their corresponding European
publications
Bibliography
Applies to the effectiveness of mammographic X-RAY EQUIPMENT, with respect to image quality and dose, in combination with aspects of EQUIPMENT safety.
DevelopmentNote |
For CENELEC adoptions of IEC publications, please check www.iec.ch to be sure that you have any corrigenda that may apply. (01/2017)
|
DocumentType |
Standard
|
Pages |
134
|
PublisherName |
National Standards Authority of Ireland
|
Status |
Current
|
Standards | Relationship |
BS EN 61223-3-2:2008 | Identical |
EN 61223-3-2:2008 | Identical |
NF EN 61223-3-2 : 2008 | Identical |
DIN EN 61223-3-2:2010-01 | Identical |
UNE-EN 61223-3-2:2009 | Identical |
SN EN 61223-3-2 : 1996 | Identical |
IEC 61223-3-2:2007 | Identical |
ISO 3386-1:1986 | Polymeric materials, cellular flexible — Determination of stress-strain characteristics in compression — Part 1: Low-density materials |
IEC 60336:2005 | Medical electrical equipment - X-ray tube assemblies for medical diagnosis - Characteristics of focal spots |
EN 60601-2-45:2011/A1:2015 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-45: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF MAMMOGRAPHIC X-RAY EQUIPMENT AND MAMMOGRAPHIC STEREOTACTIC DEVICES (IEC 60601-2-45:2011/A1:2015) |
IEC 61674:2012 | Medical electrical equipment - Dosimeters with ionization chambers and/or semiconductor detectors as used in X-ray diagnostic imaging |
IEC 60601-1:2005+AMD1:2012 CSV | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance |
ISO 845:2006 | Cellular plastics and rubbers — Determination of apparent density |
EN 61676:2002/A1:2009 | MEDICAL ELECTRICAL EQUIPMENT - DOSIMETRIC INSTRUMENTS USED FOR NON-INVASIVE MEASUREMENT OF X-RAY TUBE VOLTAGE IN DIAGNOSTIC RADIOLOGY |
ISO 9236-3:1999 | Photography Sensitometry of screen/film systems for medical radiography Part 3: Determination of sensitometric curve shape, speed and average gradient for mammography |
IEC TR 60788:2004 | Medical electrical equipment - Glossary of defined terms |
IEC 62220-1-2:2007 | Medical electrical equipment - Characteristics of digital X-ray imaging devices - Part 1-2: Determination of the detective quantum efficiency - Detectors used in mammography |
CFR 21(PTS800-1299) : 0 | FOOD AND DRUGS - FOOD AND DRUG ADMINISTRATION, CHAPTER 1 DEPARTMENT OF HEALTH AND HUMAN SERVICES - PARTS 800-1299 |
ISO 4090:2001 | Photography Medical radiographic cassettes/screens/films and hard-copy imaging films Dimensions and specifications |
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 |
EN 60336:2005 | Medical electrical equipment - X-ray tube assemblies for medical diagnosis - Characteristics of focal spots |
IEC 60601-1-3:2008+AMD1:2013 CSV | Medical electrical equipment - Part 1-3: General requirements forbasic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment |
IEC 61223-3-1:1999 | Evaluation and routine testing in medical imaging departments - Part 3-1: Acceptance tests - Imaging performance of X-ray equipment for radiographic and radioscopic systems |
IEC 61223-3-3:1996 | Evaluation and routine testing in medical imaging departments -Part 3-3: Acceptance tests - Imaging performance of X-ray equipmentfor digital subtraction angiography (DSA) |
IEC 61223-3-4:2000 | Evaluation and routine testing in medical imaging departments - Part 3-4: Acceptance tests - Imaging performance of dental X-ray equipment |
IEC 60627:2013 | Diagnostic X-ray imaging equipment - Characteristics of general purpose and mammographic anti-scatter grids |
IEC 61676:2002+AMD1:2008 CSV | Medical electrical equipment - Dosimetric instruments used for non-invasive measurement of X-ray tube voltage in diagnostic radiology |
IEC 61223-2-4:1994 | Evaluation and routine testing in medical imaging departments - Part 2-4: Constancy tests - Hard copy cameras |
EN 573-3:2013 | Aluminium and aluminium alloys - Chemical composition and form of wrought products - Part 3: Chemical composition and form of products |
IEC 60601-2-45:2011+AMD1:2015 CSV | Medical electrical equipment - Part 2-45: Particular requirements for the basic safety and essential performance of mammographic X-ray equipment and mammographic stereotactic devices |
IEC 61223-2-5:1994 | Evaluation and routine testing in medical imaging departments - Part 2-5: Constancy tests - Image display devices |
EN 61674:2013 | Medical electrical equipment - Dosimeters with ionization chambers and/or semiconductor detectors as used in X-ray diagnostic imaging |
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