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

Standard No.

IEC 61223-3-2:2007

Release Date

2007

Published By

International Electrotechnical Commission (IEC)

Latest

IEC 61223-3-2:2007

Replace

IEC 62B/651/FDIS:2007 IEC 61223-3-2:1996

Scope

This part of IEC 61223 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 CASSETTES, 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. NOTE 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 a) the essential parameters which describe the performance of the above-mentioned mammographic X-RAY EQUIPMENT with regard to image quality and dose; and b) 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 TEST. Tests required by a higher level of compliance take precedence over similar tests with a lower level of compliance. This concept is described in 4.1. 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).

IEC 61223-3-2:2007 Referenced Document

• IEC 60336:2005 Medical electrical equipment - X-ray tube assemblies for medical diagnosis - Characteristics of focal spots
• IEC 60601 Medical electrical equipment - Part 3-1: Essential performance requirements for transcutaneous oxygen and carbon dioxide partial pressure monitoring equipment
• IEC 60601-1 Medical electrical equipment - ALL PARTS*， 2015-01-20 Update
• IEC 61674 Medical electrical equipment - Dosimeters with ionization chambers and/or semiconductor detectors as used in X-ray diagnostic imaging*， 2012-11-01 Update
• IEC 61676:2002 Medical electrical equipment - Dosimetric instruments used for non-invasive measurement of X-ray tube voltage in diagnostic radiology
• ISO 4090 Photography - Medical radiographic cassettes/screens/films and hard-copy imaging films - Dimensions and specifications
• ISO 9236-3 Photography - Sensitometry of screen/film systems for medical radiography - Part 3: Determination of sensitometric curve shape, speed and average gradient for mammography

IEC 61223-3-2:2007 history

• 2007 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
• 1996 IEC 61223-3-2:1996 Evaluation and routine testing in medical imaging departments - Part 3-2: Acceptance tests - Imaging performance of mammographic X-ray equipment