BS EN 61223-3-2-2008 医学成像部门内的评估和例行测试.第3-2部分:验收测试.乳房X光照射设备的成像性能

标准号：BS EN 61223-3-2-2008
中文标准名称：医学成像部门内的评估和例行测试.第3-2部分:验收测试.乳房X光照射设备的成像性能
英文标准名称：Evaluation and routine testing in medical imaging departments -Part 3-2: Acceptance tests - Imaging performance of mammographic X-ray equipment
标准类型：C43
发布日期：2008/9/30 12:00:00
实施日期：2008/9/30 12:00:00
中国标准分类号：C43
国际标准分类号：11.040.50
引用标准：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
适用范围：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.