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IEC 61223-3-1:1999

Withdrawn

Withdrawn

A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

Evaluation and routine testing in medical imaging departments - Part 3-1: Acceptance tests - Imaging performance of X-ray equipment for radiographic and radioscopic systems

Available format(s)

Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users

Withdrawn date

31-12-2021

Language(s)

English, Spanish, Castilian

Published date

24-03-1999

€280.71
Excluding VAT

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 Test parameters
      4.5 Test equipment including PHANTOMS (ATTENUATION
             devices) and TEST DEVICES
      4.6 Evaluating the test 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 for RADIOSCOPY
      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 are 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 contract TEST DEVICES
Annex D (informative) Examples of requirements (accuracy,
                      tolerances, discrepancies according to
                      actual IEC standards or state of the
                      art)
Annex E (informative) Bibliography
Table B.1 - Test parameters, symbols and units
Table D.1 - Typical values of FOCAL SPOT dimensions for
            NOMINAL FOCAL SPOT VALUES
Table D.2 - Values for the discrepancy parameters X, Y and Z
            according to IEC 60601-1-3
Table D.3 - Typical values for the TRANSMISSION KERMA index
Table D.4 - Typical values for the ATTENUATION RATIO of
            material between the PATIENT and the X-RAY IMAGE
            RECEPTOR
Figure 1 - Measuring arrangement for RADIOGRAPHY and
           RADIOSCOPY EQUIPMENT for AIR KERMA measurements
Figure 2 - Measuring arrangement for RADIOGRAPHY and
           RADIOSCOPY EQUIPMENT to test geometry and
           resolutions
Figure 3 - LINE PAIR RESOLUTION TEST DEVICE
Figure 4 - TOMOGRAPHY LINE PAIR RESOLUTION TEST DEVICE
Figure 5 - Discrepancies in visual indication of the X-RAY
           FIELD
Figure 6 - Discrepancies in covering the IMAGE RECEPTION AREA

Applies to those components of X-ray equipment which influence the image quality and patient dose of diagnostic X-ray systems using radiographic and radioscopic imaging systems.Defines:- the parameters which describe the performance of X-ray equipment with regard to imaging properties and patient dose;- methods of testing wether measured quantities related to those parameters comply with the specific tolerances.The aim is to verify compliance of the installation with specifications relating to the image quality and patient dose, and to detect malfunctions that are not in agreement with those specifications.

DevelopmentNote
Also numbered as BS EN 61223-3.1 (05/2005)
DocumentType
Standard
Pages
47
PublisherName
International Electrotechnical Committee
Status
Withdrawn

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
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
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 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
IEC 60417-1:2002 Graphical symbols for use on equipment - Part 1: Overview and application
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 60580:2000 Medical electrical equipment - Dose area product meters
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 61267:2005 Medical diagnostic X-ray equipment - Radiation conditions for use in the determination of characteristics
IEC 60601-1-1:2000 Medical electrical equipment - Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical systems

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