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 SUS

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1 3T-MR 1575 Magnetic resonance imaging MRI 20 MRI radio frequency RF 3T T-MR MRI RF MR RF 3T 3T 1.5T 1.5T MRI MRI MRI MRI MRI 1-2

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 SUS SUS T Z Z GIANTURCO Z-GIANT- URCO Z- SUS304 Z- Z- SUS316 SUS316 SUS304 Z RF RF RF MRI Vol. 63 No

3 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 SNR SAR MRIRF MRI MRI MRI MRI MRI I. RF 1-2 MRI MRI risk / benefit Shellock FG 3 Food and Drug Administration FDA 1 MR Safe MR MRI 2 MR Compatible MR MR Safe MR MR Compatible MR SafeMR Compatible MRI MRI MRI MR Compatible MRI

4 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 MR Unsafe MR MRI Shellock FG Unsafe 1 Unsafe ASTM MRI MR Safe MR MR MR Conditional MR MR Unsafe MR ASTM MRI FDA MR SafeMR Compatible T-MR MR MR MR IEC MR JIRA MR 1-1 MR 2002 IEC JIS JIS Z JIS FDA IEC Fig

5 3T-MR 1579 Fig. 1 MR Fig. 2 IEC IEC MR MR 0.5mT 5 2 MR Amendment Fig MRIMR MR Amendment MRI MR MRI JIS Z4951 Amendment IEC

6 1580 JIS 4T MR MR MR MRIEC 2007 IEC 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 F e F F a 11 4 F F MR MR safe, MR compatible, MR unsafe MR ASTM 2007 IEC IEC ASTM FDA MRI 14 ASTM 64 12

7 3T-MR 1581 Table 1 IEC IEC T 3T 2T 3T 4T 4T 4T 4T Table 2 SAR EC EC >10 >10 >20 >20 >20 >40 W/kg 2-1 IEC IEC MR IEC IEC CDV Amendment IEC ISO14971 MRI T 3T 3T 3T 2 4T Table SAR SAR 2 SAR Table 2 SAR PNS 2 PNS peripheral nerve stimulation 3 PNS MR MR 2-2 ISO TS IEC ISO International Organization

8 1582 for Standardization IEC SC62B ISO TC150/SC6 AIMD Active Implant Medical Device MR 2010ISO TS Technical Standard MR ASTM ICNIRP International Commission on Non-Ionizing Radiation Protection 16 MRI MRI IEC MR IEC Amendment 2 MR MR17 Class IIMR MR JIRA MR MR MR MR JIS Z4951 MR 5mT 5 JIRA MRFig. 3 MR MR 3-2 MR 64 12

9 3T-MR 1583 Fig. 3 MR 3-3 MR 3-4 MR JIS T1022 MR Table 3 MR SNR IEC QA RF SNR MR 3-5

10 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 MR 64 12

11 3T-MR T-MR IEC 1.5T MR 2009 MRIMRI MRI Shellock 18 3T-MR 2006 JIRA JCLA T-MR 3T Vol. 63 No ASTM deflection angle test 20 15cm 1.3mg θ Fig. 4a 1 MR gauss / cm Fig. 4a TMR Philips Achieva 3.0T Nova Dual JCLA cm Fig. 4b 15cm Fig. 4c T m gθf dyn Fig. 5a F=mg tanθ cm 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.

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.

12 1586 Fig. 4 a b 15cm c a b c 2-1 Table dyn dyn dyn 2-2 Table No mm No mm 3T MR compatible No Table 5 No. 7 3 MR ASTM 3 MR No gauss/cm 20T/s 15 MR 2.0W/kgSAR Fig. 5 a F b MR MR No. 8 No. 23 MR MR Fig T No No No MR Fig. 7 8 a b 64 12

13 3T-MR 1587 Table 4

14 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 FT764T AAR30 5 Fig. 10b 7 FT764T AAR MR compatible 0 Fig. 10a 7 MR compatible L Fig. 10c 8 CD HORIZON M8 ASTM F136ASTM F67 Medtronic 1 9 M cage SR Ti-6AI-4V ASTM F STD Med, Inc T-MRI compatible COOK INCORPORATED T 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 T-MRI compatible COOK INCORPORATED 3 17 Cordis 1 18 Cordis 0 19 Cordis MP35N Medtronic 5 21 MP35N Medtronic 22 MP35N Medtronic 3 23 Boston Scientific Tsunami TERUMO MULTI LINK SUS316L PIXEL S-Stent SUS316L BIOSENSORS INTERNATIONAL TAXUS 2 SUS316L Boston Scientific MULTI LINK ZETA GUIDANT S-Stent SUS316L BIOSENSORS INTERNATIONAL MULTI LINK VISION L605 GUIDANT 6 31 Cypher Cordis Duraflex 316L AVANTEC VASCULAR Duraflex 316L AVANTEC VASCULAR Fig. 7a 34 2 Fig. 7b 35 SDSφ mm Medtronic TiMesh ST TiMesh ST HA +ΗΑ 2 Fig. 8a 3 Fig. 8b Fig. 8c

15 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

16 MRI 45 MRI db/dt RF MR Tsunami T-MR 1.5T 6 8 MRI 3T 1.5T3T 1.5T T 3T 4-1 MR 4-2 3T-MR compatible MRI 2 RF MR MR FSE fast spin echo RF EPI echo planer imaging

17 3T-MR 1591 RF 1995 IEC IEC JIS IEC 21 SAR MRI MRI RF 22, 23 MRI Q&A 24 RF Shellock MR 25 MRI MRI MRI 3T-MR RF 3T-MR RF ASTM deflection angle test 28 RF Fig. 9a 20 40cm 14cm 13kgFig. 9b RF 2cm Fig. 9c TMR 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 Fig. 11a 2 10m 2. Fig. 11b RF MR MRI

18 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.

19 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

20 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 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

21 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 S/m 50 m Fig. 15 RF RF 3.0T4.5cm 1.5T Fig T RF SAR SAR 3.0T SAR RF 3-3 RF RF RF RF

22 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

23 3T-MR American Society for Testing and Materials ASTM MR Safe MR Conditional MR Unsafe ΙΙ. 3, 4, T 1.5T 3.0T 1.5T MR shick0.5t 7.0T RF RF 1.5T 1.5T 3.0T SN

24 T 3.0T MR 1 NMR-CT NMR MRI Shellock FG. Reference manual for magnetic resonance safety, implants, and devices: 2008 edition. Biomedical Research Publishing Group, Los Angeles, 2008: 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 IEC nd ED. Medical electric equipment Part 2-33: Particular requirements for safety of magnetic resonance for medical diagnosis JIS Z IEC rd ED. Medical electrical equipment Part 1: General requirements for basic safety and essential performance IEC Magnetic resonance equipment for medical imaging Part 1: Determination of essential image quality parameters ASTM F e1. Standard test method for measurement of magnetically induced displacement force on medical devices in the magnetic resonance environment. 10 ASTM F Standard test method for evaluation of MR image artifacts from passive implants. 11 ASTM F a. Standard test method for measurement of radio frequency induced heating near passive implants during magnetic resonance imaging. 12 ASTM F Standard test method for measurement of magnetically induced torque on medical devices in the magnetic resonance environment. 13 ASTM F 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 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 JIRAMR anzen/04_information/pdf/mr_guideline_06_1115_ Rev1_1.pdf 18 Shellock FG. Evaluation of magnetic resonance safety for 64 12

25 3T-MR 1599 heart valve prostheses and annuloplasty rings Los Angeles: Shellock R&D Services MR 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 In: Annual Book of ASTM Standards, Volume Medical Devices; emergency medical services. West Conshohocken, PA: ASTM; 2002: JIS Z 495, MRI Shellock FG, Slimp GL. Severe burn of the finger caused by using a pulse oximeter during MR imaging letter. AJR Am J Roentgenol 1989; : Kanal E MRI Q&A Shellock FG. Radiofrequency energy-induced heating during MR procedures: a review. J Magn Reson Imaging 2000; 12 1 : MR Dempsey MF, Condon B. Thermal injures associated with MRI. Clin Radiol 2001; 56 6 : 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 a , MRI T-MRI RF 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 : 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 : 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 : IEC Medical electrical equipment-part 2-33, Particular requirements for the safety of magnetic resonance equipment for medical diagnosis 2nd Edition

IEC :2014 (ed. 4) の概要 (ed. 2)

IEC :2014 (ed. 4) の概要 (ed. 2) IEC 60601-1-2:2014 (ed. 4) (ed. 2) e 2018 4 2 1 1 2 / 1 2.1............... 2 2.2............... 3 2.3.................. 4 3 6 4 6 4.1.................. 6 4.1.1............... 7 4.1.2....... 7 4.1.3............