T/CSBME 006-2019 in English
VALIDSafety assessment of the magnetic resonance imaging for active implantable medical device—Method of the equivalent tissue-simulating medium
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| Standard No: | T/CSBME 006-2019 |
| Document status: | VALID |
| Title in English: | Safety assessment of the magnetic resonance imaging for active implantable medical device—Method of the equivalent tissue-simulating medium |
| Title in Chinese: | 有源植入器械在磁共振环境下安全性评价 射频安全性等效组织模拟介质法 |
| Language: | English |
| File Format: | Electronic (PDF) |
| Delivery: | Via email within 1~3 business days |
| ICS Classification: | 11.040.40-Implants for surgery, prosthetics and orthotics |
| Chinese Classification: | C30-Medical apparatus and devices in general |
| Professional Classification: | T/-Social Organization Standard |
| Related Keywords: | active implantable medical device method
active implantable medical devices safety assessment radio frequency safety radio frequency safety evaluation methods |
| Related Topics: | Subzero environment simulation
Magnetic security wire Magnetic Resonance Safety Sign Sources t/imas 006-2019 t/cswsl 006-2019 t/ucst 006-2019 t/csbme 078 cts 006-2019 t/jlhx 006-2019 |
本标准规定了植入了有源植入式医疗器械（以下简称AIMD)的患者在核磁共振（以下简称MR)环境下进行检查时基于等效组织模拟介质法的射频安全性评价的方法。
本标准不适用于非植入器械在MR环境下安全性评价。
本标准的目的是评价AIMD运行是否存在严重危害，不涉及产品的具体符合性标准，也不涉及这些试验过程中由于器械行为反应产生的风险确定。
本标准指定的试验是预期用于AIMD的型式试验，旨在证实AIMD与MR扫描仪相关的磁场和电磁场之间的交互的安全性。
本标准不包括非植入部分的要求。
注： 本标准是基于1.5T、3.0T的研究数据得出的，其他场强的MR可参照此方法标准进行。
Scope
This standard implements radio frequency safety evaluation methods for patients with active implantable medical devices to be examined in an MRI environment. This standard makes corresponding provisions in terms and definitions, general considerations for the application of standard requirements, safety evaluation of active implantable medical devices in MR environments: radio frequency safety equivalent tissue simulation medium method, etc.
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