BS 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
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.
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.
BS EN 61223-3-2:2008 Referenced Document
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
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
BS EN 61223-3-2:2008 history
2008BS 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