Schaefers Gregor, Melzer Andreas
MR Testing Laboratory, MR:comp GmbH, Gelsenkirchen, Germany.
Minim Invasive Ther Allied Technol. 2006;15(2):71-5. doi: 10.1080/13645700600640865.
Magnetic resonance (MR) safety and image compatibility are important issues when using medical devices in the environment of magnetic resonance imaging (MRI). MR testing of medical devices is required for device approval by the FDA and the EU notified bodies. Testing methods have been established for basic issues and were published as first ASTM International standards (formerly ASTM, the American Society of Testing and Materials). Moreover, individual safety concerns such as the safe functioning of the device and the MR system are a necessity for medical devices within an MR environment. Standardized tests increase the safety of the patient and support both the MR user and the device manufacturers. This paper describes the state of the art of MR testing methods and requirements for medical devices.
在磁共振成像（MRI）环境中使用医疗设备时，磁共振（MR）安全性和图像兼容性是重要问题。FDA和欧盟公告机构批准设备需要对医疗设备进行MR测试。针对基本问题已建立测试方法，并作为首批ASTM国际标准（原ASTM，美国材料与试验协会）发布。此外，对于MR环境中的医疗设备而言，诸如设备和MR系统的安全运行等个人安全问题是必要的。标准化测试提高了患者安全性，并对MR用户和设备制造商均有帮助。本文描述了MR测试方法的现状以及对医疗设备的要求。
