1) PIMDs無源植入醫療器械磁共振兼容檢測 (PIMDs MRI safety testing)
a. 典型產品: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. 圖像偽影 ASTM F2119 (Image Artifacts)
d. 射頻致熱 ASTM F2182(heating)
e. 磁致扭矩 ASTM F2213(torque)
2) AIMDs 有源植入醫療器械磁共振兼容檢測(AIMDs MRI safety testing)
a. 典型產品:起搏器、神經刺激器、輸液泵、壓力傳感器等(classical
product: pacemaker, deep brain stimulator (DBS), spinal cord stimulator
(SCS), etc...)
b. 磁致振動、預期外刺激、器械故障 ISO TS10974 (Gradient induced vibration, Unintended Stimulation, Device Malfunction)
c. ISO TS10974 (HPC為標準起草發起者)(HPC is the Initiator of the Joint Working Group responsible for ISO
TS 10974)
3) MDAPs 附加在患者身上的醫療器械磁共振兼容性檢測(MDAPs MRI safety testing)
a. 典型產品:腦電圖電極、心電圖電極等(classical product: EEG
electrodes, ECG electrodes, etc....)
b. 暫無通行標準(磁共振兼容的專業能力、全球頂尖專家的可及性及FDA的密切關系可以確保為客戶提供全球最專業、最權威、最高性價比的解決方案)(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 部分植入人體的醫療器械磁共振兼容檢測(PIPOs MRI safety testing)
a. 典型產品:外部整形固定器、導管、血糖檢測儀等。(classical product: external
orthopedic fixator, catheters, glucose monitor, etc....)
b. 暫無通行標準(磁共振兼容的專業能力、全球頂尖專家的可及性及FDA的密切關系可以確保為客戶提供全球最專業、最權威、最高性價比的解決方案)(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))