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BS EN 61223-3-3:1997

Current

Current

The latest, up-to-date edition.

Evaluation and routine testing in medical imaging departments Acceptance tests - Imaging performance of X-ray equipment for digital subtraction angiograp hy

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

15-06-1997

€165.94
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 and test devices
    4.6 Evaluating the test results
5 Test methods for x-ray equipment for DSA
    5.1 Identification
    5.2 Check of documents
    5.3 Decision on representative DSA operation modes
    5.4 Visual and functional tests
    5.5 Air kerma measurements
    5.6 Dynamic range
    5.7 DSA contrast sensitivity
    5.8 DSA visual spatial resolution
    5.9 Artifacts
    5.10 Compensation for attenuation non-linearity
          (optional)
6 Test report and statement of compliance
Annexes
A Terminology - Index of defined terms
B Example of a DSA phantom without test step for
    compensation
C Example of a DSA phantom with test step for compensation
ZA (normative) Normative references to international
    publications with their corresponding European
    publications

Applicable to those components of x-ray equipment which influence the image quality of equipment for digital subtraction angiography using an imaging system consisting of an x-ray generation subsystem, a detection device consisting of an x-ray image intensifier television chain, means of digitization and a digital image processing, image storage and image manipulation including subtraction, and facilities for image display. ALSO NUMBERED AS BS 7725 SECTION 3.3 1997

Committee
CH/62/2
DevelopmentNote
Also numbered as BS 7725-3.3(1997) and IEC 61223-3-3 Supersedes 94/508379 DC (11/2005)
DocumentType
Standard
Pages
22
PublisherName
British Standards Institution
Status
Current
Supersedes

1.1 Scope This part of IEC1223 applies to those components of X-ray equipmentwhich influence the image quality ofequipmentfor digital subtraction angiography (DSA) with an imaging system consisting of an X-raygeneration subsystem, a detection device comprising an X-ray image intensifiertelevision chain, means of digitization and digital image processing, image storage and image manipulation including subtraction, and facilities for image display. This standard does not apply to general equipment of digital imaging. If such an equipment includes a DSA function, it is restricted to the DSA function. 1.2 Object This part of IEC1223 defines: the essential parameters which describe the performance of the above-mentioned components of X-ray equipmentwith regard to imaging properties; methods of testing whether measured quantities related to those parameters comply with specified tolerances. These methods mainly rely on non-invasive measurements using appropriate test equipment performed during the installation or after the installation is completed. Signed statements covering steps in the installation procedure can be used as part of acceptance testing. The aim is to verify compliance of the installation with specifications affecting the image quality, and to detect malfunctions affecting the image quality that are not in agreement with those specifications. This standard does not in itself specify tolerances for the parameters under investigation. Neither is it intended to consider: aspects of mechanical and electrical safety; aspects of mechanical, electrical and software performance unless they are essential to the performance of the tests directly affecting the image quality.

Standards Relationship
UNE-EN 61223-3-3:1998 Identical
NF EN 61223-3-3 : 1997 Identical
EN 61223-3-3:1996 Identical
SN EN 61223-3-3 : 1996 Identical
DIN EN 61223-3-3:2000-12 Identical
I.S. EN 61223-3-3:1997 Identical

BS EN 60601-1-3 : 2008 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)
BS EN 61223-2-4:1995 Evaluation and routine testing in medical imaging departments. Constancy tests Method for hard copy cameras
BS 5724-1(1989) : 1989 AMD 6715 MEDICAL ELECTRICAL EQUIPMENT - GENERAL REQUIREMENTS FOR SAFETY
BS 6641:1985 Glossary of medical radiology terms
BS EN 61223-2-5:1995 Evaluation and routine testing in medical imaging departments. Constancy tests Method for image display devices
BS 7725-1:1994 Evaluation and routine testing in medical imaging departments. General
BS 7139:1989 Guide to graphical symbols for use on medical electrical equipment
ISO 2092:1981 Light metals and their alloys Code of designation based on chemical symbols
BS 6217:1981 Guide to graphical symbols for use on electrical equipment

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