1) PIMDs无源植入医疗器械磁共振兼容检测 (PIMDs MRI safety testing)
a. 典型产品:血管植入物、非血管植入物、骨科植入物等 (classical
product: Vascular implants, non vascular implants, orthopedic implants and so
on)
b. 磁致位移力 ASTM F2052 ( force)
c. 图像伪影 ASTM F2119 (Image Artifacts)
d. 射频致热 ASTM F2182(heating)
e. 磁致扭矩 ASTM F2213(torque)
2) AIMDs 有源植入医疗器械磁共振兼容检测(AIMDs MRI safety testing)
a. 典型产品:起搏器、神经刺激器、输液泵、压力传感器等(classical
product: pacemaker, deep brain stimulator (DBS), spinal cord stimulator
(SCS), etc...)
b. 磁致振动、预期外刺激、器械故障 ISO TS10974 (Gradient induced vibration, Unintended Stimulation, Device Malfunction)
c. ISO TS10974 (HPC为标准起草发起者)(HPC is the Initiator of the Joint Working Group responsible for ISO
TS 10974)
3) MDAPs 附加在患者身上的医疗器械磁共振兼容性检测(MDAPs MRI safety testing)
a. 典型产品:脑电图电极、心电图电极等(classical product: EEG
electrodes, ECG electrodes, etc....)
b. 暂无通行标准(磁共振兼容的专业能力、全球顶尖专家的可及性及FDA的密切关系可以确保为客户提供全球最专业、最权威、最高性价比的解决方案)(no
standardized test method(Magnetic resonance compatible expertise, access to the
worlds leading experts and close relationships with FDA ensure that customers
are provided with the most professional, authoritative and cost-effective
solutions in the world))
4) PIPOs 部分植入人体的医疗器械磁共振兼容检测(PIPOs MRI safety testing)
a. 典型产品:外部整形固定器、导管、血糖检测仪等。(classical product: external
orthopedic fixator, catheters, glucose monitor, etc....)
b. 暂无通行标准(磁共振兼容的专业能力、全球顶尖专家的可及性及FDA的密切关系可以确保为客户提供全球最专业、最权威、最高性价比的解决方案)(no
standardized test method(Magnetic resonance compatible expertise, access to the
worlds leading experts and close relationships with FDA ensure that customers
are provided with the most professional, authoritative and cost-effective
solutions in the world))