3T-MR 1575 Magnetic resonance imaging MRI 20 MRI radio frequency RF 3T 2006 4 3T-MR MRI RF MR RF 3T 3T 1.5T 1.5T 1 1-1 MRI MRI MRI MRI MRI 1-2
1576 MRI MRI MRI MRI 1.5T 3T 3T 3T-MR MRI MRI 3T 3 1.5T 6 3T MRI SUS316 3T SAR2.0W/kg 15 MR 3T MRI 8 MRI SUS316 SUS304 SUS410 SUS420 SUS430 SUS444 SUS316 SUS304 1990 SUS304 2 1.5T 70 80 Z Z GIANTURCO Z-GIANT- URCO Z- SUS304 Z- Z- SUS316 SUS316 SUS304 Z RF RF RF MRI Vol. 63 No. 4 64 12
3T-MR 1577 RF specific absorption ratio SAR 3T SAR SAR 2 1.5T RF SARSAR 1.5T 3T 3T 3T SAR SE refocusing pulse flip angle 100 120 SNR SAR MRIRF MRI MRI MRI MRI MRI I. RF 1-2 MRI MRI risk / benefit Shellock FG 3 Food and Drug Administration FDA http://www.fda.gov/cdrh/ode/primerf6.html 1 MR Safe MR MRI 2 MR Compatible MR MR Safe MR MR Compatible MR SafeMR Compatible MRI MRI MRI MR Compatible MRI
1578 MR Safe MR Compatible American Society for Testing and Materials ASTM MR 4 ASTM MR Safe MR Conditional MR Unsafe 1 MR Safe MR MRI MR Safe MR Safe 2 MR Conditional MR MRI MRI db/dt RF SAR MR Conditional MR MRI RF MR Shellock FG Conditional 1 Conditional 7 7 3 3 MR Unsafe MR MRI Shellock FG Unsafe 1 Unsafe 2 2 4 ASTM MRI MR Safe MR MR MR Conditional MR MR Unsafe MR ASTM MRI FDA MR SafeMR Compatible 2005 12 3T-MR MR MR MR IEC MR JIRA MR 1-1 MR 2002 IEC60601-2-33 2 5 JIS JIS Z49512004 6 JIS FDA IEC Fig. 1 64 12
3T-MR 1579 Fig. 1 MR Fig. 2 IEC60601-2-33 IEC60601-1 7 MR MR 0.5mT 5 2 MR Amendment 1 2005 Fig. 2 2004 MRIMR MR Amendment 2 2007 MRI MR MRI JIS Z4951 Amendment IEC60601-2-33 3
1580 JIS 4T MR MR 2008 7 1-2 MR MRIEC 2007 IEC62464-1 2007 8 MR 1 NEMA National Electrical Manufacturers Association MRI SNR SNR 200mm 50 90kg 150mm 5mm TR 1000ms T1 3 TE 30ms T2 1/3 100±3Hz440mm 250mm 5 2 ROI S ROI SD standard deviation SNR S SNR = SD 2 30mm 15 IEC Amendment 2 TR 2 ROI SD SNR SNR = S SD ( 4 π)/ 2 1 ROI SD SNR SNR MR JIRA JIS 2008 JIS JIS 1-3 MR MR ASTM FDA ASTM 1 F2052-06e1 9 45 2 F2119-07 10 3 F2182-02a 11 4 F2213-06 12 5 F2503-05 13 MR MR safe, MR compatible, MR unsafe MR ASTM 2007 IEC IEC ASTM 2008 8 21FDA MRI 14 ASTM 64 12
3T-MR 1581 Table 1 IEC60601-2-33 2 IEC60601-2-33 3 2T 3T 2T 3T 4T 4T 4T 4T Table 2 SAR EC60601-2-33 2 EC60601-2-33 3 10 10 20 10 10 20 10 10 20 20 20 40 >10 >10 >20 >20 >20 >40 W/kg 2-1 IEC60601-2-33 3 IEC60601-1 2005 3 MR IEC60601-2-33 2 IEC CDV 2009 2 Amendment 1 2 3 3 IEC60601-1 3 ISO14971 MRI 2-1-1 1.5T 3T 3T 3T 2 4T Table 1 2-1-2 SAR SAR 2 SAR 3 3 2 Table 2 SAR 2-1-3 PNS 2 PNS peripheral nerve stimulation 3 PNS 2-1-4 MR MR 2-2 ISO TS IEC ISO International Organization
1582 for Standardization IEC SC62B ISO TC150/SC6 AIMD Active Implant Medical Device MR 2010ISO TS Technical Standard MR ASTM 2-3 2004 15 2008 ICNIRP International Commission on Non-Ionizing Radiation Protection 16 MRI MRI 4 2012 IEC MR IEC60601-2-33 Amendment 2 MR MR17 Class IIMR MR JIRA MR 17 3-1 MR MR MR JIS Z4951 MR 5mT 5 JIRA MRFig. 3 MR MR 3-2 MR 64 12
3T-MR 1583 Fig. 3 MR 3-3 MR 3-4 MR JIS T1022 MR Table 3 MR SNR IEC62464-1QA RF SNR 5 10 3 4 MR 3-5
1584 1 a. b. c. d. e. f. g. 2 a. b. 3 a. b. c. d. e. 4 a. b. c. d. 5 a. b. c. 6 a. SNR b. c. d. SMPTE Table 3 MR 1 2 UPS 3 4 3-6 MR 64 12
3T-MR 1585 1 2 3 4 5 3T-MR IEC 1.5T MR 2009 MRIMRI MRI Shellock 18 3T-MR 2006 JIRA JCLA 2007 3T-MR 3T Vol. 63 No. 4 2007 4 19 1-1 ASTM deflection angle test 20 15cm 1.3mg θ Fig. 4a 1 MR gauss / cm Fig. 4a 1-2 3.0TMR Philips Achieva 3.0T Nova Dual JCLA 8 17 15cm Fig. 4b 15cm Fig. 4c 10 40 49 2 1.5T m gθf dyn Fig. 5a F=mg tanθ 18 45 67cm 14.5cmFig. 5b 558.7gauss/cm
1586 Fig. 4 a b 15cm c a b c 2-1 Table 4 2 8 5.5dyn 10 6.9dyn 0 3 2.1dyn 2-2 Table 5 45 90 45 No. 2 950mm No. 6 840mm 3T MR compatible No. 7 11 23 30 4 Table 5 No. 7 3 MR 2 27 45 ASTM 3 MR No. 30 3.0 450gauss/cm 20T/s 15 MR 2.0W/kgSAR Fig. 5 a F b MR MR No. 8 No. 23 MR MR Fig. 6 1.5T No. 2 4 5 6 No. 7 14 15 16 17 18 30 11 No. 19 24 28 32 32 6 8 MR Fig. 7 8 a b 64 12
3T-MR 1587 Table 4
1588 Table 5 No. angle 3T angle 1.5T Fig. No. 1 Niti-STM CMI 30 Fig. 6a 2 Boston Scientific 0 2 Boston Scientific 90 3 Boston Scientific 0 Fig. 10d 4 Nitinol Boston Scientific 0 Fig. 6b 5 Wallstent RP Boston Scientific 10 Fig. 6c 6 GDC Detachable Coil Boston Scientific 0 6 90 7 FT764T AAR30 5 Fig. 10b 7 FT764T AAR30 4 7 MR compatible 0 Fig. 10a 7 MR compatible 20 7 3 6L 20 7 2 Fig. 10c 8 CD HORIZON M8 ASTM F136ASTM F67 Medtronic 1 9 M cage SR Ti-6AI-4V ASTM F136-79 STD Med, Inc. 3 10 3T-MRI compatible COOK INCORPORATED 2 11 1.5T OK COOK INCORPORATED 0 12 COOK INCORPORATED 0 13 not affect of MRI polysulfone COOK INCORPORATED 0 14 COOK INCORPORATED 28 6 Fig. 10f 15 COOK INCORPORATED 0 16 1.5T-MRI compatible COOK INCORPORATED 3 17 Cordis 1 18 Cordis 0 19 Cordis 20 4 20 MP35N Medtronic 5 21 MP35N Medtronic 22 MP35N Medtronic 3 23 Boston Scientific 16 4 24 Tsunami TERUMO 20 3 25 MULTI LINK SUS316L PIXEL 14 3 26 S-Stent SUS316L BIOSENSORS INTERNATIONAL 16 3 27 TAXUS 2 SUS316L Boston Scientific 15 28 MULTI LINK ZETA GUIDANT 19 4 29 S-Stent SUS316L BIOSENSORS INTERNATIONAL 14 30 MULTI LINK VISION L605 GUIDANT 6 31 Cypher Cordis 16 3 32 Duraflex 316L AVANTEC VASCULAR 17 4 33 Duraflex 316L AVANTEC VASCULAR 16.5 3 34 8 Fig. 7a 34 2 Fig. 7b 35 SDSφ1.6 3.5mm Medtronic 0.5 36 TiMesh ST30463 1 37 TiMesh ST32772 2 38 38 + +HA +ΗΑ 2 Fig. 8a 3 Fig. 8b 39 + 4 Fig. 8c 40 1.5 64 12
3T-MR 1589 Fig. 6 a Niti-S TM b c Wallstent RP a b Fig. 7 a b a b c Fig. 8 a b c
1590 3-1 MRI 45 MRI db/dt RF MR 3-2 20 Tsunami 10 10 10 20 45 17 3T-MR 1.5T 6 8 MRI 3T 1.5T3T 1.5T 4 6 1.5T 3T 4-1 MR 4-2 3T-MR compatible MRI 2 RF MR MR FSE fast spin echo RF EPI echo planer imaging 91-1 64 12
3T-MR 1591 RF 1995 IEC IEC60601-2-33 1999 JIS IEC 21 SAR MRI MRI RF 22, 23 MRI Q&A 24 RF Shellock MR 25 MRI 26 27 MRI MRI 3T-MR RF 3T-MR RF ASTM deflection angle test 28 RF 1-1 29 9 0.19 26 Fig. 9a 20 40cm 14cm 13kgFig. 9b RF 2cm Fig. 9c. 1-2 3.0TMR Philips Achieva 3.0T Nova Dual GE Signa Excite 3.0T HDx SAR 15 2 Fig. 10a b 4 Fig. 10c f 1-3 FL-2000 2 Fig. 11a 2 10m 2. Fig. 11b 1 1 15 RF MR MRI
1592 Fig. 9 a b c Fig. 10 a b c d e f Fig. 11 a FL-2000 b 64 12
3T-MR 1593 Fig. 12 RF Table 6 Whole-body averaged SAR FT764T AAR30 ASTM F136 Achieva 3.0T Nova Dual 0.9W/kg 0.1 C Signa Excite 3.0T HDx 2.1W/kg 0.2 C 0.4 C 1-4 RF RF RF Fig. 12 MR 2-1 Table 6 10mm 30mm 2.1W/kg 0.4 C 2-2 Table 7 Philips Achieva 3.0T Nova Dual SAR 0.9W/kg GE Signa Excite 3.0T HDx SAR 2.1W/kg 0.9 C 2-3 RF RF 8 CRF 1.9 C Fig. 13a MR Fig. 13b 3-1RF 30 RF
1594 Table 7 Whole-body averaged SAR ASTM F138 ASTM F1537 Achieva 3.0T Nova Dual 0.9W/kg Signa Excite 3.0T HDx 2.1W/kg 0.5 C 1.9 C 8.0 C 10.9 C 9.0 C 15.2 C Fig. 13 RF a RF b RF MR a b MR RF RF CSF 31 3-2 RF MR SAR RF 1.5T 32, 33 Fig. 14 Fig. 14 SAR 15 RF Fig. 10c SAR GE Signa Excite 3.0T HDx 15.2 C 50mm 4, 0.9 C RF 64 12
3T-MR 1595 Fig. 14 SAR RF Fig. 15 Fig. 10c Fig. 15 5cm 1/2 RF RF δ = ( πµσf ) 1/ 2 1.5T RF63.8MHz 0.769S/m RF 37 RF 7.3cm 1.35 10 6 S/m 50 m Fig. 15 RF RF 3.0T4.5cm 1.5T Fig. 15 1.5T RF SAR SAR 3.0T SAR RF 3-3 RF RF RF RF
1596 MRIRF 1 MRI 2 SAR 3 4 MR RF 4 6, 34 XV B F F X V B db/dr T 2 T X V B2 MR RF RF MRI RF MR RF SAR 3T SAR 6, 34 RF RF RF RF 64 12
3T-MR 1597 32 33 American Society for Testing and Materials ASTM MR Safe MR Conditional MR Unsafe ΙΙ. 3, 4, 18 http://www.mrisafety.com/ 1.5T 1.5T 3.0T 1.5T MR shick0.5t 7.0T RF RF 1.5T 1.5T 3.0T SN
1598 1.5T 3.0T MR 1 NMR-CT NMR 1984 179-198 2 MRI 1990 10 6 558-562 3 Shellock FG. Reference manual for magnetic resonance safety, implants, and devices: 2008 edition. Biomedical Research Publishing Group, Los Angeles, 2008: 346-354. 4 American Society for Testing and Materials ASTM. Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment. ASTM International, West Conshohocken. 2005. 5 IEC60601-2-33 2 nd ED. Medical electric equipment Part 2-33: Particular requirements for safety of magnetic resonance for medical diagnosis. 2002. 6 JIS Z 4951 2004 7 IEC60601-1 3rd ED. Medical electrical equipment Part 1: General requirements for basic safety and essential performance. 2005. 8 IEC62464-1. Magnetic resonance equipment for medical imaging Part 1: Determination of essential image quality parameters. 2007. 9 ASTM F2052-06e1. Standard test method for measurement of magnetically induced displacement force on medical devices in the magnetic resonance environment. 10 ASTM F2119-07. Standard test method for evaluation of MR image artifacts from passive implants. 11 ASTM F2182-02a. Standard test method for measurement of radio frequency induced heating near passive implants during magnetic resonance imaging. 12 ASTM F2213-06. Standard test method for measurement of magnetically induced torque on medical devices in the magnetic resonance environment. 13 ASTM F2503-05. Standard practice for marking medical devices and other items for safety in the magnetic resonance environment. 14 Guidance for Industry and FDA Staff Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance MR Environment. 2008. 15 Directive 2004/40/EC of the European Parliament and of the Council of 29 April 2004 on the minimum health and safety requirements regarding the exposure of workers to the risks arising from physical agents electromagnetic fields. 16 ICNIRP Guidelines for limiting exposure to time-varying electric, magnetic, and electromagnetic fields Up to 300 GHz. 1998. 17 JIRAMR www.jira-net.or.jp/commission/houki_ anzen/04_information/pdf/mr_guideline_06_1115_ Rev1_1.pdf 18 Shellock FG. Evaluation of magnetic resonance safety for 64 12
3T-MR 1599 heart valve prostheses and annuloplasty rings Los Angeles: Shellock R&D Services 2002 19 MR 2007 63 4 390-393 20 Standard test method for measurement of magnetically induced displacement force on passive implants in the magnetic resonance environment. American Society for Testing and Materials ASTM Designation. F 2052. In: Annual Book of ASTM Standards, Volume 13.01 Medical Devices; emergency medical services. West Conshohocken, PA: ASTM; 2002: 1576-1580. 21 JIS Z 495, 1999 22 MRI 1999 19 5 303-309 23 Shellock FG, Slimp GL. Severe burn of the finger caused by using a pulse oximeter during MR imaging letter. AJR Am J Roentgenol 1989; 153 5 : 1105. 24 Kanal E MRI Q&A 1999 19 7 482-488 25 Shellock FG. Radiofrequency energy-induced heating during MR procedures: a review. J Magn Reson Imaging 2000; 12 1 : 30-36. 26 MR 2 2004 24 2 88-91 27 Dempsey MF, Condon B. Thermal injures associated with MRI. Clin Radiol 2001; 56 6 : 457-465. 28 Standard test method for measurement of radio frequency induced heating near passive implants during magnetic resonance imaging. American Society for Testing and Materials ASTM Designation. F 2182-02a. 40-43, 2006 29 MRI 2000 20 8 365-373 30 1.5T-MRI RF 2000 56 11 1371-1375 31 Rezai AR, Finelli D, Nyenhuis JA, et al. Neurostimulation systems for deep brain stimulation: in vitro evaluation of magnetic resonance imaging-related heating at 1.5 tesla. J Magn Reson Imaging 2002; 15 3 : 241-250. 32 Muranaka H, Horiguchi T, Usui S, et al. Dependence of RF heating on SAR and implant position in a 1.5T MR system. Magn Reson Med Sci 2007; 6 4 : 199-209. 33 Muranaka H, Horiguchi T, Usui S, et al. Evaluation of RF heating on humerus implant in phanoms during 1.5T MR imaging and comparisons with electromagnetic simulation. Magn Reson Med Sci 2006; 5 2 : 79-88. 34 IEC60601-2-33. Medical electrical equipment-part 2-33, Particular requirements for the safety of magnetic resonance equipment for medical diagnosis 2nd Edition. 2006.