医用電気機器－ 第 2-XXX 部:電位治療器の 安全に関する個別要求事項
Contents
1. E SC estie AIR e bocca Decree i pedo ut EE 1 1 E SIGNAL T LN 1 E EESJEIDO AUT E 2 HEELS RRIDEE CDD 2 KS gp 2 60 Ni 3 2 DR I UM o mer 3 3 pei elt m Done 3 19 esee RB 3 LN CE oue EP eco tenant ce 4 4 HEBIEIRITAE SUB ese Nebel eee 4 5 kk 4 36 COE m ROT ODDO 4 62. Dp RE LAT Bl A2
3. S1 JIS T 0601 1 51 S1 101 15 000 Vrms 24 000 V 5 6000V 50 2 101 S
4. 20cmX10cm a 3 JIS T 0601 1 19 4 f g h JIST 0601 1 19 2 102 SmA JIS T 0601 1 20
5. nij mul E u s 15 T 2002 2006 4 JIS JIS
6. 2 JIS C 9335 2 32 2 32 3 JIS C 9335 2 32 3 3 1
7. 6 9 a 1 2 0 5 3 1kQ b 1 1 1 1 2 1 3 14 1 1 1 3 1 5 2 1kQ c 1
8. J LTE H 18 kg JIS C 9335 1 3 JIS C 9335 1 3 JIS C 9335 1 3 3 12 3 13 3 T 2002 2006 3 14 3 15
9. 30 50 2 50 2 4001 50 2 S0 2 101 59 20
10. 20cm X10cm 20 JIST 0601 1 20 20 2 B a 1 4U V 20cmX10cm 4 JIS T 0601 1 4 5 JIS T 0601 1 5
11. E f zs BEOL SI odd dde E H
12. 5 IR ERE 4k dB F R BE A x x fT dB vB TEL 03 5770 1571 FAX 03 3405 S541 JIS 1
13. CTI E ts c 51 101 e LIS d 51 102 1000 V 60 8
14. JIS JIS T 0601 2 JIS JIS 5 E JIS JIS JIS 5
15. M 38 AAH DA 10 T 2002 2006 c 2 2 1 2 2 2 3 2 4 2 5 3 3 1 3 2 3 3 3 4 4 4 1 4 2 4 3 4 4 4 5 5 5 1 5 2 1 1 PR 2 Is JEH FH G ti Jg gt 2 TA JEDA GR OF QNM GE
16. 1 2005 17 JIS Jj IEC 1998 10 3 2 2 Part 1 General requirements for safety
17. 7 JIS C 9335 2 32 7 a 1 2 9
18. 2 3 JIS T 0601 1 2 3 JIST 0601 1 3 19 JIST 0601 1 19 JIS T0601 1 19 4 a 101 JIS T 0601 1 OR 4
19. S JIS 25 SA x wh E HE gu B R fa E 4r X m d OM H
20. 1 3 1 TEL03 3301 1511 Qe 15 100 8901 1 5F TEL03 3805 6131 5 T 2002 2006 DE pus SS EI 1 PER D po 1 RES c N6p x DII SS 1 E oe T 3 4 1 ooA 3 4 2 3 UN e m S S 4 Sq BEB S npe nemen ntu purple ee 4 R2 d ooo Due dete iuda EE eee 4 EE i Ea aE i N CE E 5 6 C WI DL BL CL M N CEEE A 6 UNES DT NIU 6 62 CSIEORBUDA ovre deter eoe tete teh a d etis 6 6 3 m WD 6 6 4 PF 6 65 Ad XOBMBDDRe aee Nee ecce 7 66 7 6 7 _ UH oo Noo id eb o tese RIN MP accede da 7 6 8 m AI IDA we MEM 8 69 _
21. AN CU JATO Ji KON d T ODE E IE 5 B A 1 11 T 2002 2006 A
22. 3 16 3 17 3 18 3 19 3 20 4 4 1 JMDN ic o Xo 430 X213 5 a b c d e f g 4 2 4 1 a b
23. 2 c 1 1 6 4 a D 0 1 WAF 2 2 GERNER b 1 2 c D 1 6 5 Im Jy E ge p RR
24. 2 3 Efe H EE E E c d e
25. 20 2 JIS Z 4711 X 8 1 8 X 1 1 50 2 101 5 209 1 1 25 1 4 b 50 2 101
26. j 2 x f 2 B T 5 T2002
27. 2 3 b D 2 3 c D 6 7 1 2 0 5 a b 1 2 c HANZ OWD JRE lt 1 1 E EZ C 1 100mm 60 kg 0 1 8 T 2002 2006 1
28. 2 T 2002 2006 32 3 3 3 4 3 5 3 6 3 7 3 8 3 9 3 10 3 11
29. 14 15 1 6 V W Hz 1 7 ERR VERE 18
30. Eb JIS T0601 2 2 RET Do JIS T0601 1 20 H VI 7 HELTE EIRE JIS T0601 1 DR 4 SmA IEC479 1 20cm X 10cm
31. iE ix JIS T 0601 1 zx 343 2 f amp pA T ARD JIS T 0601 1 101 aa bb UL nij cu JIS T0601 1 1 1 JIS T0601 1 1 G 11 2 1 101 1 12 2 1 101 1 3
32. 6 5 1 30 2 EED k 1 0 1 MQ 6 6 1 2 6 6 2 3 6 6 2 53 E JIS C 9335 2 32 a JISC 9335 2 32 6 b
33. 1 2 2 2 1 2 1 101 ELECTRIC POTENTIAL EQUIPMENT 2 1 102 RATED OUTPUT VOLTAGE 2 1 103 OUTPUT THERAPHY CURRENT 3 2 3 8 6 6 8 2 aa D X 1 m
34. a D b 1 c 1 6 6 6 6 1 a 1 2 b 1 500 V 2 3 4 c 1 2 6 6 2 a 1 x 0 1 500 V 10 mm 30 mm 7 T 2002 2006 1H 70cm 500 V
35. 300 W 67 2388 c 90 6 8 R 1 1 6 8 2 b C A 100 E MIZO 0 0D 115 B IZO 6 0 125 120 F f amp 5o t 0 150 140 HIZO DO 170 165 iE d 42V FB 42 V 6 T 2002 2006 0 5mA
36. 8 JIS S HE m du 9 JIS JIS T 2002 30e HAPI JSA 14 12 1 HAPD JSA JIST 2002 2005
37. JIS T 0601 1 15 JIS T 0601 1 1 1 JIS T 0601 1 2 1A JIS T 0601 1 1 JIS T 0601 1 1 1 1 JIS T 0601 1 2 W i z xn PB m x 1 Tee lc D O ARDRE 8 2
38. 0000 00 00 3 AR 4 4 a 19 4 DIAO H H Xu 1 JIS T0601 2 10 OT
39. UA eiie ee mou JIS T 2002 2006 MEA ME K Fi 17 3 25 113 0034 1 24 TEL 03 5770 1573 iz Hx 1 2 2 TEL03 5253 mee pr a YR 100 8916
40. JIS T 0601 1 1999 SG1 N041R6 Essential Principles GHTF IEC60601 1 Medical electrical equipment JE 1 of Safety and performance of Medical Devices including IN Vitro Diagnostic Devices October 14 2002 3 1 JIS C 9335 2 32 1 JIS C 9335 2 32
41. Meere nee eene entente 8 EEA E E 8 A 11 EN AA o o o ooo oor PRI ede euet eroe eats 13 GE JIS T 2002 2006 Massage appliances and digital compressor for home use 1 T 100 V SELV
42. 2 http www jsaorjp JIS JIS http www jsa orjp TEL 03 3583 8002 FAX 03 3583 0462 JIS T 2002 17 3 23 1 107 8440 4 1 24 060 0003 3 3 1 TEL 011 261 0045 FAX 011 221 4020 REF 02760 7 4351 77980 0014 3 5 2 TEL 022 227 8336 FAX 022 266 0905 li 02200 4 8166 460
43. 6 9 6 6 1 JIS C 9335 2 32 5 3 12 JIS C 9335 2 32 3 1 9 6 2 a D 5 2 150 kPa b 1 2 c D 63 a D 0 1 2 5 b D
44. 3 83 AX e ar ec Ej H py JIS C 9335 2 32 22 E Un io mi rt w Y a 2 4 b BO 1 34 7 300 6 3 34 150 6 3 0 65 9 cm 6 4 E D 5 mm
45. AK A 3 2 5 0 1 kg I EP 1850 1 kg A1 A 2 12 T 2002 2006 lt g N ti E 5 lt o 9 E ce CO 80 370 150 590 A 3 230 B PA E b 13 T 2002 2006 JIS T 2002 2006 ft
46. 2 32 JIS C 9335 2 32 Ts JMDN Japan Medical Device Nomenclature 3 3 1 JMDN 32 JMDN 3 3 JMDN 14 T 2002 2006 34 JMDN 3 5 JMDN 3 6 JMDN 3 7 JM
47. T2002 2006 EJ 3 4 5 6 b 1 14 12 1 3
48. c d 5 4 T2002 2006 5 4 4 1 a 6 2 1 120kPa 2 48 kPa 6 3 c 25 1700 6 3 b
49. 4 7 asees eessssssesssssseesstesreerreerreereeereerreeeeeesreeses 4 8 oe 5 50 5 51 dee HaT mE E ooo af ce edet tende tete echten ens 5 9 8 ir 6 CEI a O N E 6 FEM C M A 7 T 0601 2 XXX 0000 JIS T0601 2 XXX sete Xr 2 XXX Medical electrical eduipment Part2 XXX Particular requirements for the safety of electric potential equipment JIS T 0601 1 1 JIST 0601 1 JIS T 0601 1 JIST 0601 1 EHZ JIST 0601 1 JIS T 0601 1
50. 3 T 0601 2 XXX 0000 14 12 1 JIPT JSA i
51. 6 8 a 1 2 5 3 b 1 909 2 90 JIS C 9335 1 11 3 4 c 1 2 90
52. 0008 2 6 1 TEL 052 221 8316 FAX 032 203 4806 lie 00800 2 23283 341 0053 3 4 10 TEL 06 6261 8086 FAX 06 6261 9114 lier 00910 2 2636 730 0011 5 44 TEL 082 221 7023 7035 7036 FAX 082 223 7568 IRIE 01340 9 9479 760 0023 2 2 10 TEL 087 821 7851 FAX 087 821 3261 lie 01680 2 3359 812 0023 1 31 TEL 092 282 9080 FAX 092 282 9118 lie 01790 21632 ooooo Printed in Japan JAPANESE INDUSTRIAL STANDARD Massage appliances and digital compressor for home use JIS T 2002 2we HAPI JSA Established 2006 00 00 Investigated by Japanese Industrial Standards Committee Published by Japanese Standards Association 1050 ICS 11 040 60 97 170 Reference number JIS T 2002 0000 J
53. 1 102 8 5 E 9 JIS T 0601 1 9 10 JIS T 0601 1 10 6 JIS T 0601 x xxx 2006 2 xxx 1 Ya 2005 2321
54. 2006 g A n EL 42V 42V i p
55. 36 JIS T 0601 1 2 6 JIS T 0601 1 6 7 4 JIS T 0601 1 7 8 JIST 0601 1 8 50 JIS T 0601 1 50 50 1 30
56. DN 5 1 5 2 d 522 0 5s 2 5 2 5 3 JIS C 9335 2 32 7
57. JIS 2 XXX JIS T 0601 2 XXX v JIPT JSA 00 00 H 00 XE T 0601 2 XXX 0000 ER E 00 00 00 0 00 00 113 0033 3 3 1 KS TEL 03 3811 8522 107 8440 4 1 24 TEL 03 5770 1573 d 100 8916 2 2 TEL03 3233 1111 DT 100 8901 1 3 1 TEL 03 3501 1511 15
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