BS EN 61223-3-2:2008 - Evaluation and routine testing in medical imaging departments. Acceptance tests. Imaging performance of mammographic X-ray equipment – BSI British Standards

BS EN 61223-3-2:2008

Evaluation and routine testing in medical imaging departments. Acceptance tests. Imaging performance of mammographic X-ray equipment

Status : Current, Under review   Published : September 2008



BS EN 61223-3-2:2008 Evaluation and routine testing in medical imaging departments. Acceptance tests. Imaging performance of mammographic X-ray equipment

This standard is part of a series of international Standards that give the methods of acceptance testing and constancy testing for diagnostic X-ray equipment.

This second edition of the particular standard for the acceptance tests of mammographic X-ray equipment describes test methods for equipment using radiographic films, equipment using storage phosphor plates, equipment using integrated digital X-ray image receptors and mammographic stereotactic devices.

BS EN 61223-3-2 applies to the effectiveness of mammographic X-ray equipment, with respect to image quality and dose, in combination with aspects of equipment safety.

This standard applies to mammographic X-ray equipment and mammographic stereotactic devices.

The tests described in this standard require the quality and performance of the X-ray image receptors to be assured prior to the acceptance testing when they are not an integral part of the mammographic X-ray equipment.

This includes radiographic films, intensifying screens, radiographic screens, storage phosphor plates and associated equipment such as film processors or storage phosphor plate readers, image display devices and hard copy cameras.

For testing radiographic cassettes and intensifying screens, this standard makes reference to ISO 4090. Sensitivity and contrast for the screen-film image receptors are considered to be stated according to ISO 9236-3.

Currently there exists no IEC standard for acceptance testing of hard copy cameras or image display devices.

By the measurements described in this standard, data for average glandular dose calculation can be determined.

When the results of the acceptance test are in compliance with the expected values, the baseline values for the subsequent constancy tests are established.

This part of IEC 61223 defines:

  • The essential parameters which describe the performance of the above-mentioned mammographic X-ray equipment with regard to image quality and dose
  • The methods of testing whether measured quantities related to those parameters comply with specified tolerances.

These methods mainly rely on non-invasive measurements that use appropriate test equipment and are performed during or after the installation. Signed statements covering steps in the installation procedure can be used as part of the acceptance tests.

Tests required by a higher level of compliance take precedence over similar tests with a lower level of compliance.

This standard does not in itself specify limiting values or tolerances for the parameters under investigation.

A difficulty may arise with regard to the responsibility for acceptance testing when the film/screen combination, film processing chemistry or computed radiography system is changed. This arises from a combination of causes. Firstly, the image receptor manufacturer and the X-ray equipment manufacturer may be different. Secondly a change in image receptor or film processing chemistry may alter the system performance. When system integration such as the above occurs, it is important that acceptance testing is performed.

When a change occurs which could alter system performance, it is essential that the system integrator (i.e. whoever is responsible for this change) discusses the implication of their change with the X-ray equipment manufacturer so that the latter can adjust the imaging system if necessary.

Acceptance testing of mammographic X-ray equipment requires average skill in medical physics. However, the decision concerning who performs the test is determined by local rules (e.g. contract, regulation, law).

Contents of BS EN 61223-3-2 include:

  • Introduction
  • Scope
  • Normative references
  • Terms and definitions
  • General aspects of the acceptance test
  • Levels of compliance
  • Test conditions
  • Test equipment
  • Evaluating the test results
  • Test methods for mammographic X-ray equipment
  • X-ray tube voltage
  • Attenuation ratio of material between the upper surface of the patient support and the image reception plane
  • Breast compression device
  • Biopsy needle positioning accuracy of mammographic stereotactic devices
  • Baseline values for constancy tests
  • Test report and statement of compliance
  • Test devices and arrangements for testing the automatic exposure control system with a digital X-ray image receptor
  • Bibliography
  • Terminology
  • Symbols, physical quantities, abbreviations and units used in this standard

Standard NumberBS EN 61223-3-2:2008
TitleEvaluation and routine testing in medical imaging departments. Acceptance tests. Imaging performance of mammographic X-ray equipment
StatusCurrent, Under review
Publication Date30 September 2008
Normative References(Required to achieve compliance to this standard)ISO 4090, IEC 61674, EN 61674:1997, EN 60601-2-45:2001, EN 61676:2002, IEC/TS 61223-2-1, IEC 60601, IEC 61676:2002, IEC 60601-2-45, IEC 60336:2005, EN 60601, EN 60336:2005, ISO 9236-3, EN 60601-1:2006, IEC 60601-1
Informative References(Provided for Information)IEC 61223-1:1993, ISO 3386-1, IEC 60601-2-28:2017, EN 60627:2001, IEC 60601-1-3, IEC 61223-3-3, IEC 61223-2-4, IEC 62220-1-2, EN 62220-1-2:2007, EN 60601-1-3:2008, EN 61223-3-1:1999, EN ISO 3386-1:1997, IEC 60788:2004, IEC 60878, EN 61223-3-3:1996, IEC 61223-3-1, EN 61223-3-4:2000, IEC 61223-3-4, IEC 60417, EN 61223-2-5:1994, IEC 61223-2-5, EN 61223-2-4:1994, EN 60601-2-28:1993, IEC 60627, EN 573-3:2003, ISO 845
ReplacesBS EN 61223-3-2:1997, IEC 61223-3-2:1996,BS 7725-3.2:1997
International RelationshipsEN 61223-3-2:2008,IEC 61223-3-2:2007
DescriptorsApproval testing, Performance testing, Mammography apparatus, X-rays, Acceptance (approval), X-ray apparatus, Visual inspection (testing), Medical equipment, Test equipment, Medical radiography, Performance, Electrical wave measurement, Electrical medical equipment, Attenuation, Medical radiology, Instructions for use, Radiology apparatus (medical)
Title in FrenchEssais d'évaluation et de routine dans les services d'imagerie médicale. Essais d'acceptation. Performance d'imagerie des appareils de mammographie à rayonnement X
Title in GermanBewertung und routinemäßige Prüfung in Abteilungen für medizinische Bildgebung. Abnahmeprüfungen. Leistungsmerkmale zur Bildgebung von Röntgen-Einrichtungen für die Mammographie
ISBN978 0 580 55611 1
File Size1.092 MB

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