Keeler E K, Casey F X, Engels H, Lauder E, Pirto C A, Reisker T, Rogers J, Schaefer D J, Tynes T
Diagnostic Imaging and Therapy Systems Division, National Electrical Manufacturers Association, Rosslyn, VA 22209, USA.
J Magn Reson Imaging. 1998 Jan-Feb;8(1):12-8. doi: 10.1002/jmri.1880080107.
The MR Section of The National Electrical Manufacturers Association (NEMA), in response to a request from the Food & Drug Administration (FDA), recently issued a position paper to address generic issues related to the compatibility of accessory equipment produced by third party equipment manufacturers or MR equipment users and intended to be used in conjunction with MR equipment or within the MR scanning room. The recommendations concern scanning accessories, such as radiofrequency (RF) coils, patient monitoring equipment and injectors, as well as patient comfort accessories and positioning devices. The following issues related to safety performance are discussed: (a) the interaction of the equipment with the MR scanner, (b) interactions of the MR scanner with the equipment, and (c) potential safety hazards for patients and staff that can be posed by accessory equipment in the MR scan environment. The recommendations are based on combined input from NEMA member companies who manufacture MR systems and MR accessories and are presented for consideration in the design of MR accessory products and incorporation of these concepts into testing plans to ensure MR compatibility of third party devices.
美国国家电气制造商协会（NEMA）的磁共振（MR）部门应美国食品药品监督管理局（FDA）的要求，最近发布了一份立场文件，以解决与第三方设备制造商或MR设备用户生产的、打算与MR设备配合使用或在MR扫描室内使用的附属设备兼容性相关的一般性问题。这些建议涉及扫描附件，如射频（RF）线圈、患者监测设备和注射器，以及患者舒适附件和定位设备。讨论了以下与安全性能相关的问题：（a）设备与MR扫描仪的相互作用，（b）MR扫描仪与设备的相互作用，以及（c）MR扫描环境中的附属设备可能对患者和工作人员造成的潜在安全危害。这些建议基于制造MR系统和MR附件的NEMA成员公司的综合意见，旨在供MR附件产品设计时参考，并将这些概念纳入测试计划，以确保第三方设备的MR兼容性。
