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BS EN 61223-3-1:1999

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

Evaluation and routine testing in medical imaging departments Acceptance tests - Imaging performance of X-ray equipment for radiographic and radiscopic systems
Available format(s)

Hardcopy , PDF

Superseded date

30-04-2016

Language(s)

English

Published date

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.

This part of IEC 62047 defines terms for micro-electromechanical devices including the process of production of such devices.

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

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

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 60601-2-28 : 3.0 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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