標準號：BS EN 61223-3-2-2008
中文標準名稱：醫學成像部門內的評估和例行測試.第3-2部分:驗收測試.乳房X光照射設備的成像性能
英文標準名稱：Evaluation and routine testing in medical imaging departments -Part 3-2: Acceptance tests - Imaging performance of mammographic X-ray equipment
標準類型：C43
發布日期：2008/9/30 12:00:00
實施日期：2008/9/30 12:00:00
中國標準分類號：C43
國際標準分類號：11.040.50
引用標準：IEC 60336-2005;IEC 60601;IEC 60601-1;IEC 60601-2-45;IEC 61223-2-1;IEC 61674;IEC 61676-2002;ISO 4090;ISO 9236-3
適用范圍：This part of IEC 61223 applies to the effectiveness of mammographic X-RAY EQUIPMENT, withrespect to image quality and dose, in combination with aspects of EQUIPMENT safety.This standard applies to mammographic X-RAY EQUIPMENT and MAMMOGRAPHIC STEREOTACTICDEVICES.The tests described in this standard require the quality and performance of the X-RAY IMAGERECEPTORS to be assured prior to the acceptance testing when they are not an integral part ofthe mammographic X-RAY EQUIPMENT. This includes RADIOGRAPHIC FILMS, INTENSIFYINGSCREENS, RADIOGRAPHIC CASSETTES, storage phosphor plates and ASSOCIATED EQUIPMENT suchas film processors or storage phosphor plate readers, IMAGE DISPLAY DEVICES and HARD COPYCAMERAS.For testing RADIOGRAPHIC CASSETTES and INTENSIFYING SCREENS, this standard makesreference to ISO 4090. Sensitivity and contrast for the screen-film image receptors areconsidered to be stated according to ISO 9236-3.When the results of the ACCEPTANCE TEST are in compliance with the expected values, thebaseline values for the subsequent CONSTANCY TESTS are established.This part of IEC 61223 definesa) the essential parameters which describe the performance of the above-mentionedmammographic X-RAY EQUIPMENT with regard to image quality and dose; andb) the methods of testing whether measured quantities related to those parameters complywith specified tolerances.These methods mainly rely on non-invasive measurements that use appropriate testEQUIPMENT and are performed during or after the installation. Signed statements coveringsteps in the installation procedure can be used as part of the ACCEPTANCE TEST. Testsrequired by a higher level of compliance take precedence over similar tests with a lower levelof compliance. This concept is described in 4.1.This standard does not in itself specify limiting values or tolerances for the parameters underinvestigation.A difficulty may arise with regard to the responsibility for acceptance testing when thefilm/screen combination, film processing chemistry or computed radiography system ischanged. This arises from a combination of causes. Firstly, the image receptor MANUFACTURERand the X-RAY EQUIPMENT MANUFACTURER may be different. Secondly a change in imagereceptor or film processing chemistry may alter the system performance. When systemintegration 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 systemintegrator (i.e. whoever is responsible for this change) discusses the implication of theirchange with the X-RAY EQUIPMENT MANUFACTURER so that the latter can adjust the imagingsystem if necessary.