BS EN 61223-3-1:1999
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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Evaluation and routine testing in medical imaging departments Acceptance tests - Imaging performance of X-ray equipment for radiographic and radiscopic systems
Hardcopy , PDF
30-04-2016
English
15-08-1999
INTRODUCTION
Clause
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 Test parameters
4.5 Test equipment including PHANTOMS (ATTENUATION
devices) and TEST DEVICES
4.6 Evaluating the tests results
5 Test methods for RADIOGRAPHY EQUIPMENT
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 indication of the extent of the
X-RAY BEAM
5.6 *Linearity and reproducibility of TRANSMISSION
KERMA or RADIATION OUTPUT
5.7 *ATTENUATION RATIO of material between the
PATIENT and the X-RAY IMAGE RECEPTOR
5.8 *AUTOMATIC EXPOSURE CONTROL (AEC)
5.9 LINE PAIR RESOLUTION for DIRECT RADIOGRAPHY
5.10 *AIR KERMA area product indicator
6 Test methods for RADIOSCOPY EQUIPMENT
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 Functioning of the AUTOMATIC EXPOSURE RATE
CONTROL (AERC)
6.6 Limitation of the extent of the X-RAY BEAM
6.7 ATTENUATION RATIO of material between the
PATIENT and the X-RAY IMAGE RECEPTOR
6.8 *AIR KERMA RATE at the ENTRANCE PLANE of the
X-RAY IMAGE INTENSIFIER
6.9 *Entrance AIR KERMA RATE for RADIOSCOPY with
X-RAY IMAGE INTENSIFIER
6.10 AIR KERMA at the ENTRANCE PLANE of the X-RAY
IMAGE INTENSIFIER for CINERADIOGRAPHY or other
INDIRECT RADIOGRAPHY systems (excluding digital
systems)
6.11 Entrance AIR KERMA for CINERADIOGRAPHY or other
INDIRECT RADIOGRAPHY systems (excluding digital
systems)
6.12 *LINE PAIR RESOLUTION for RADIOSCOPY with X-RAY
IMAGE INTENSIFIER and for CINERADIOGRAPHY or
other INDIRECT RADIOGRAPHY systems (excluding
digital systems)
6.13 *LOW CONTRAST RESOLUTION for RADIOSCOPY with
X-RAY IMAGE INTENSIFIER and for CINERADIOGRAPHY
or other INDIRECT RADIOGRAPHY systems (excluding
digital systems)
6.14 AIR KERMA area product indicator
7 Additional tests required for TOMOGRAPHY EQUIPMENT
7.1 *Requirements
7.2 Test method
8 Test report and statement of compliance
Annex A (normative) Terminology - Index of defined terms
Annex B (informative) Test parameters, symbols and units
Annex C (informative) Examples of low contrast TEST DEVICES
Annex D (informative) Examples of requirements (accuracy,
tolerances, discrepancies) according
to actual IEC standards or state of
of the art
Annex E (informative) Bibliography
Annex ZA (normative) Normative references to international
publications with their corresponding
European publications
Tables
B.1 Test parameters, symbols and units
D.1 Typical values of FOCAL SPOT dimensions for NOMINAL
FOCAL SPOT VALUES
D.2 Values for the discrepancy parameters X, Y and Z
according to IEC 60601-1-3
D.3 Typical values for the TRANSMISSION KERMA index
D.4 Typical values for the ATTENUATION RATIO of material
between the PATIENT and the X-RAY IMAGE RECEPTOR
Figures
1 Measuring arrangement for RADIOGRAPHY and RADIOSCOPY
EQUIPMENT for AIR KERMA measurements
2 Measuring arrangement for RADIOGRAPHY and RADIOSCOPY
EQUIPMENT to test geometry and resolutions
3 LINE PAIR RESOLUTION TEST DEVICE
4 TOMOGRAPHY LINE PAIR RESOLUTION TEST DEVICE
5 Discrepancies in visual indication of the X-RAY FIELD
6 Discrepancies in covering the IMAGE RECEPTION AREA
Applicable to those components of Z-Ray equipment which influence the image quality and patient dose of diagnostic X-ray systems using radiographic and radioscopic imaging systems: RADIOGRAPHY EQUIPMENT, for example: Stationary, mobile, skull and lung radiography equipment, Tomography equipment (excluding computed tomography), Radiography devices (Spotfilm Devices) in radioscopy equipment, angiography equipment (excluding DSA function), Cineradiography equipment. RADIOSCOPY EQUIPMENT: Combined radiographic and radioscopic equipment.
Committee |
CH/62/2
|
DevelopmentNote |
Also numbered as IEC 61223-3-1 Supersedes 97/560541 DC (05/2005)
|
DocumentType |
Standard
|
Pages |
44
|
PublisherName |
British Standards Institution
|
Status |
Superseded
|
SupersededBy | |
Supersedes |
This part of IEC 62047 defines terms for micro-electromechanical devices including the process of production of such devices.
Standards | Relationship |
UNE-EN 61223-3-1:2000 | Identical |
SN EN 61223-3-1 : 1999 | Identical |
NF EN 61223-3-1 : 2005 | Identical |
EN 61223-3-1:1999 | Identical |
DIN EN 61223-3-1:2001-05 | Identical |
I.S. EN 61223-3-1:1999 | Identical |
IEC 62047-1:2005 | Identical |
DIN 6868-1:1985-02 | Image quality assurance in X-ray diagnostics; general |
IEC 60601-2-7:1998 | Medical electrical equipment - Part 2-7: Particular requirements for the safety of high-voltage generators of diagnostic X-ray generators |
IEC 60336:2005 | Medical electrical equipment - X-ray tube assemblies for medical diagnosis - Characteristics of focal spots |
EN 60601-2-7:1998 | Medical electrical equipment - Part 2-7: Particular requirements for the safety of high-voltage generators of diagnostic X-ray generators |
IEC 61223-2-9:1999 | Evaluation and routine testing in medical imaging departments - Part 2-9: Constancy tests - Equipment for indirect radioscopy and indirect radiography |
DIN 6868-50:1990-06 | IMAGE QUALITY ASSURANCE IN X-RAY DIAGNOSIS; ACCEPTANCE TESTING IN DIRECT RADIOGRAPHIC & FLUOROSCOPIC X-RAY-SYSTEMS INCLUDING FILM PROCESSING |
IEC 60417-1:2002 | Graphical symbols for use on equipment - Part 1: Overview and application |
EN 60601-1-3 : 2008 AMD 11 2016 | MEDICAL ELECTRICAL EQUIPMENT - PART 1-3: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: RADIATION PROTECTION IN DIAGNOSTIC X-RAY EQUIPMENT (IEC 60601-1-3:2008/A1:2013) |
EN 61267:2006 | Medical diagnostic X-ray equipment - Radiation conditions for use in the determination of characteristics |
EN 60601-2-28:2010 | Medical electrical equipment - Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis |
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 |
EN 60417-1:2002 | GRAPHICAL SYMBOLS FOR USE ON EQUIPMENT - PART 1: OVERVIEW AND APPLICATION |
ISO 2092:1981 | Light metals and their alloys Code of designation based on chemical symbols |
HD 379 : 200S1 | AREA EXPOSURE PRODUCT METER |
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 60580:2000 | Medical electrical equipment - Dose area product meters |
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 |
HD 501 : 200S1 | MEDICAL RADIOLOGY - TERMINOLOGY |
IEC 61267:2005 | Medical diagnostic X-ray equipment - Radiation conditions for use in the determination of characteristics |
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