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:
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:
EN 61223-3-2:2008
IEC 61223-3-2:2007