超音波診断装置の安全性に関する資料
Contents
1. ERL HJ E gt gt v2. 10 SPECT 104 X CT 10 1 i 10 k H ee kT 107 10 ARFI MR FR Aix t i gi Xr M R EH E JM D TA Bl A gt SZ 2 Eu AME OMNCM I 1 1 1 RE ER EBRE i 9 9 9 O d 6
3. 022 MTomas i H 1 2009 4 2 2010 2 3 2014 4 Outline 1 2 3 ALARA TIEMI 4 5 1 Ld 2 eV 107 PET eV
4. z f MHz iz z P r NV sp MPa 7 7 zl Xe s AAE FH TIS TIB HODR EA PELDE S TIB 3 Jit 02 EU VEL CET B BER iek MI TI e MI TI mode e MI B mode e 7 B mode Rye O 4 1974
5. ISO 14971 ie e 3 7 MI ALARAOD f AU L Intensity Oo Pressure SN A 2 04 06 08 10 t us pc 1 5x106 N s m3 0 Pulse Intensity Integral PIN PII f i t Ht PLA J cm
6. a 0 3 dB cm MHz dB 0 3x3 Sx3 0 3 1SdB 10 0 70 pr 1 8 MPa x 0 7 1 3 MPa dB 0 3x8 6x1 4 3 61dB 107 0 44 7sprAu 40 mW cmz x 0 44 17 mW cmz2 TI TjL W M AERELEEREN W Wice 1 C deg REJ Wield 17 mW dB 0 3x8 6x1 4 3 61dB m 1 4 cm 8 6 MHz 107979 0 44 W 17mW x 0 44 7 40 mW mr W W 2 0740 _ f Wie 210 f 210 84 2 x LS pe OC 2f 2 j 0 i u E 1MHz 1 1 1 1 Pema p cat mee peu pc 2 2 2 Pra PialMHz MI
7. IEC 60601 2 37 IEC 60601 2 37 Ed 1 1 2001 amp Amd 1 2004 IEC 60601 2 37 Ed 1 amp Amd 1 amp Amd 2 2005 JIS T0601 2 37 2005 2005 IEC 60601 2 37 Ed 1 amp Amd 1 JIS gt IEC 60601 2 37 Ed 2 2 2007 JIS T0601 2 37 2013 2005 IEC 60601 2 37 Ed 2 2007 JIS 30 3 IEC 60601 2 37 1 99 gt IEC60602 37 Ed 1 amp Amd 1 JIS T0601 2 37 2005 3 2005 as 720 mW cm MI 1 9 FDA Track 3 gt IEC 60601 2 37 Ed 1 amp Amd 1 amp Amd 2 2005 IEC 60601 2 37 2007 JIS T0601 2 37 2013 2 1
8. gt gt Hii V 3 ALARA T M 9 e ALARA e e 7 MI TT gje T m ALARA As Low As Reasonably Achievable 00 Ai Ee orga viz es AC ey vidi gt gt gt gt A _ Pa MPa RAER KAASE MUN
9. e e 1MPa e e B 8 I e IEC JIS NN JEITA FT dk 55 WFUMB IEC IEC 60601 2 37 2001
10. ZH ETlspra 100 MWM R AORE RERA ShN tA 1984 MHz 10 1 1 W cm2 lt spT 240 mW cm lt 1984 WFUMB Recommendation 1997 Transmission electron microscopy study on the effects of the ultrasound contrast agent Levovist on hepatic cells Journal of Medical Ultrasonics 2012 39 3 107 113 X A AT 7 WFUMB e 7 lt 15C e A7 gt 4C 5 lt Bh
11. ERS 5 AXv8BBH IA CO 8x ABA RR Bm mW 3 77 TIS TIBE 1 nc sEBSEE mW 7 B mode Color flow mode E 4M 4M Qo M mode Pulsed Doppler mode X 43 a SMERTOE TIS Soft Tissue TIC LL C ran a z B one OE rrrrrrT zz HDI MIO E 3 xA 9 9
12. 00 02 04 06 08 10 t us emporal Peak Temporal Average Pulse Average Maximum intensity 1 1 u IBI D spta Im s MHO Ny i ML Time Spatial Peak Temporal Peak W cm Spatial Peak Pulse Average W cm At Hd 21 1000 Spatial Peak Temporal Average mW cm2 Maximum intensity W cm P PII pulse intensity integral 8 uJ cm PRT pulse repetition time 200 us PRF pulse repetition frequency 5 kHz I PRT PD pulse duration 0 1 us Ir PII x PRF 8 u cm x 1 FAI 0 2 ms B 8x10 x5x10 40 mw cm pp e PRT PII S J cm 3 I 80 W cm add PD 0 1 us 40 p 1 58 MPa z 3 0 cm f 3 5 MHz I spra 40 mW cm z 1 4 cm f 8 6 MHz
13. 75 1MHz 1 8 MPa Z 3 0 cm 3 5 MHz MI pialz JA dB gt MI 3 5 MHz 0 3x3 3x3 0 3 13dB 10 3 15 20 0 70 Pra 1 8 MPa x 0 7 1 3 MPa 3 MPa 0 7 1998 1 2000 35 6 2008 pp 623 630 WFUMB WFUMB Symposium on Safety and Standardization in Medical Ultrasound Synopsis Ultrasound Med Boil 18 1992 pp 33 37 RE Apfel Possibility of Microcavitation from Diagnostic Ultrasound IEEE Trans UFFC 33 2 1986 pp 139 142 CK Holland and RE Apfel An Improved Theory for the Prediction of Microcavitation Thresholds IEEE Trans UFFC 36 2 1989 pp 204 208 WFUMB http www wfumb org about statements aspx IEC 60601 2 37 Ed 1 2001 amp Amd 1 2004 amp Amd 2 2005 JIS T 0601 2 37 2005 IEC 60601 2 37 Ed 2 2007 JIS T 0601 2 37 2013
14. W cm mW cm ETU SppA SpbTA W ke Is W J s W cm2 e 77 Thermal Index e MI Mechanical Index 77 1 CC
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