~ 植込み型心臓ペ…スメーカ等承認基準の制定について
Contents
1. EN45302 1 62 16 3 23 32. SN 20
3. 9 13 1 2
4. 47 000 2Hz 9 90 2
5. 2 DT 3 1 1
6. 7 2 1 gt 14 3 1 14 3
7. MHz DIN VDE 0848 3 1 1999 06
8. 1 AE 6 27 3 27 2 27 3 27 4
9. 15 15 1 3 28 15 2 16 16 1 16 2
10. D 3 12 VDD AV D 3 13 KR VVT
11. 28 19 a 1 2 19 2 2 3 b 36 300O 1 e
12. vivo MEM TD ESE 64 1 E 6 00mm 0 10mm x 12 m y
13. 20mm 30 1 50mm 200mm 34 2 100V 5V
14. 5 RS 213525 194 8 ISO14155 ne 19 5 ps 7 M
15. 26 12 3 1 10 3 13 13 1 13 1 1 a 2 1 V 2 A 3 S b D
16. 8 5 PH 2 6 2 1 27 7
17. 10cm 0 5cm 100g 5g 82 000 2Hz 9 45 29 23 6 3 _
18. G102 2 IMQ 50Q 16 6Hz 140kHz 1 1 60 16 6Hz 140kHz 4 16 6Hz 20kHz f V 1V 20kHz 140kHz f V 1V m 20 137
19. 3
20. 2 2 3 JIST 14971
21. 8 2 ie
22. 77 uk 101 N CO a GIO 78 pe F R101 F102 4
23. 9 10 93 9 4 9 11 10 9 12
24. D 3 4 AAT 75 7 D 3 5 A V DOO A D
25. 5009 1 Rg 33 5 RF C 123 R 3 123 15mm 5002 1 Rr 33 5 pF Cp 124
26. IEC60068 2 14 1986 Nb 10 3 CE 1C 0 2 10C 3 55 2 27 27 1 1
27. 300Q 6Q 1 9g l 202 0 3 60 2 0 2 Voltad6 Benerator 2
28. 31 20 28 12 20 1 20 2 1 RCL C 330 pF 16 5 F 13 3mH 0 13 mH RL RG 10Q 0 20 Rr 2 Re Q Rg Va 140 V 7V
29. 2 1 16 4 19 1 19 8 2 2 1 19 2 3 Se 4
30. JST 14971 3 169 4
31. G102 2 1MO 1kQ 103 30Q 16 6Hz 167KHz 4 0 1V 144 C
32. 3 2 2 5 7 1 6 2 9 8 1 200 208 204 206
33. JIS T 14971 QSO14971 EN 1441 NRN RR Nc C22 6 37C 2C
34. 271 ECG 8
35. 3 2 3 3 3 4 V v 3 5 3 6 MM a 6 1 1 3 7 2 6 1 1 3 8
36. 9gI1 mL cm2 3 0 5 8 18 37 2 3 1977 2 9 19 3 0nm 100 mL 25m 5 mL
37. 23 23 1 A 23 2 TEC 60068 2 47 C60068 2 64 Fh a 5Hz 500Hz b 0 7 ms2 7Hz SHz 500Hz 9 3 30 28 8 2 d 23 3
38. 3 NR 1 4 9 6 2 1 4 1 1 9 2 1 7 2 1 6 0216002
39. 28 15 28 16 11 28 17 28 18
40. G101 G103 2 RE RT RE A 50Q 8 v H 2 1 1V 16 6Hz 20kHz 1 60 16 6Hz 20kHz 3 4 2 500kHiz 130Hz 129 2V
41. 200cm 400cm ROSE 2 10 BLF
42. 2 1 16 4 20 21 2 1 19 2 0
43. 7 8 ET 1 2 JIST14971
44. 37C 5 9g 500mm 37C C 9gI 100V 2mA 10 20 SN 1
45. JIST 14971 i 2 6 5 18B05841 8 9
46. 11 2
47. 2 2 27 5 28 22 1 1kHz
48. 3 16 v 3 17 i 1 1 3 18 3 19 _ 3 20 Z 6 1 3 3 21 6 1 2 3
49. 27 2 27 3 27 4 e 27 5 OS 27 6 10mT 27 7 27 8 1 EMD
50. 23 6 c RE EE EE ER RR 28 8 5 a 28 9 28 10 _ 28 11
51. 30Q 50Q 450 600 800 825 850 875 900 930 1610 1850 1910 2430 3000MHz 30dB AAMI PC69 6 0 2642 2 8408 AAMI PC69 6 5 50 27 6 1mT gt 150 F F103 51kQ 1 5002 1
52. ISO15223 9 11 13 8 1 8 2 2 9 22 9 2
53. 136 G 135 41 136 K 232 1 104 4 2 130Hz 30uA 104 f 16 6Hz lt f lt ikHz 50hA 1kHz lt f lt 20kHz 50uA kHz 27 3
54. 19 2 1 3 ET 28 19 e 0 f 19 2 1 103 DMME EERE RIRS 2 30 103 2 5V 0 5ms
55. 10 28 22 1 27 3 28 22 2
56. 23 lt 2 169 1 4 14 4
57. 128 0 5mm ISO 5841 3 IS 1 2 ISO 11318 DF 1 4 36 128 45 2 128
58. 4 2 1 7 3 31 0331012 BN 8 _5 i eon N 1 12 3 28 528 12 10 5 No21
59. C C C 689 C H
60. 272 27 5 3 1kHz 0 3mV 2 0mV 0 1mV
61. 38 27 2 27 8 6 1 28 8 2 d 28 22 1 7 4 27 5 1 ee v Ye 27 2 v
62. 27 5 4 27 5 4 ANSI AAAMI PC69 ANSAAMI PC69 2
63. IS T 14971 3 2 1 15 2 2 1 i 20 21 22 25 26 27 1 JIS T14971
64. Q amp A 1 1
65. _ 90 27 3 70 27 2 27 4 27 5 27 3
66. 169 JIS 14971 AA 6 5 SR
67. 25 11 9 11 10 9 a 9 4 6 ON OFF oc 1 d 37 2 500Q 1 1 2 3 4 5 6 AV e
68. 1 1 2 ISO14708 1 _2000 Implants for surgery Active implantable medical devices Part 1 General
69. 107 1 2 1 8 106 9 1 2 1 107 te tk ms 6 1 3 108 300Q 1 Rr R A Rr 100kQ 1
70. 27 3 27 8 27 3 kHz 27 4 27 2 27 3 27 5 167kHz 27 5 167kHz
71. 27 3 4 1 138 139 140 141 142 143 8 28 22 1 47 27 5 2 150kHz 10MHz 27 5 1 f 150kHz 10MHz 130Hz 100ms T 146 146 150kHz
72. 1mT 0 1mT 5000 I Rr 8 T 150 S Eo S1kQ 196 S T S T 3000Q 1 2 6 1 2 1mT
73. 3 D 4 8 5 6
74. 6 6 1 AI 28 8 37 2 00Q 1 101 101 6 1 1 6 1 1 3 PP20 5 0 2 2 0 0 2 6 1 1 1 1 0 5 6 1 2 10 6 1 3 lt 1MQ 10 6 1 4 10 6 1 5 6 1 6 6 1 8 10 AV 6 1 7 6 1 9 5
75. 1 2 3 4 6 AV 1 mm 5 9 4 2 a b 1 cm 6 2 nm Fr 3 mm
76. Vs 1 4 2 1 16 2 2 2 1 16 2 0 3
77. 0 3mV 2 0mV VDD 0 3mV 0 3mV 2 0mV EMI 4
78. 1MQ 10 PP 6 1 1 500Q 1 Ri 101 1 D Amax 3 1
79. 0 8 169 2
80. 21 2 300kHz 20V Dr WImich 37C 43 5V rms 14V 20V 14V 20V Entwurf Juni 1985 DIN VDE 0730 Teil 9
81. 95 71 3kHz 1MHz EC S19799 100kHz EC ms mms 5 rms 5 6 27 5 1MHz 10MHz 10MHz 10MHz 450MHz 27 5 3 509
82. au 55 28 12 20 2 21 22 27 28 13 28 14
83. Starmer Watson 1 2 2mm2 50 60Hz rms 50hA 1 1kHz 1 20kHz 20kHz 500kHz 2 50hA IEC 60601 2V
84. 14 1 0380001 17 3 30 8 ES 169 9 10
85. 10 10 1 10 2 Ra 2 30C 2 93 3 24 10 3 10 mL
86. 5 13 3 X X _L4 2
87. 15mm 10 10mm 122 33 5 LF Cr 122 65 57 4V 0 1V 0 5ms 0 05ms 100 2 R Z
88. 1 19 8 1 3 2
89. 142 F G H 1 10 1 143 1 J 10kO MP KR 143 c 8 44 27 4
90. 28 8 1 a 1 53 a4 1 2 mm D 2 5 1 2 ec
91. 1 ImT 0 7 10mT A i a 27 8
92. 28 23 28 24 ED 57 14 14 1 14 2 14 3 144
93. 6 169 JIST 14971 JIST 14971 2 1 6 28 6 3
94. 2 1 i 2 1 127 110 6mm 0 1mm 127 35 127 0 90
95. 19 2 1 d 37 C 2 500O 1 1 2 3 4 5 6 19 2 e 28 20 28 21 6
96. C C C 27 1 27 2 27 8 27 2 i
97. b c 1 cm 2 mm 3 mm a Fn 4 nm 5 nm 6 mm 7 6 2 1 Q 2 O 3 O e 28 4 28 8 4 a
98. 3 37 3 38 PSP 3 39 3 40 RRT 3 41 3 42 3 43 5
99. 50Q f 16 6Hz 150kHz 100ms ON 600ms OFF 145 46 EL 145 16 6Hz 150kHz Vep Vu 105 f 105 16 6Hz 150kHz Vo 16 6Hz lt f lt 1kHz 1kHz lt f lt 3kHz _2mV 1kHz 144 C D
100. KK H Cx G102 16 6Hz 150kHz 60 4 V D 1 2 IE 0 1 1 10 1
101. MP35N 47 000 CEN CENELBC JWG AIMD 2
102. 2 1 28 JIST 14971 1 6 43 2 ERR
103. D S 3 I F O 74 D 4 4 D 102 D 102 AAI AAT AOO DDD A Y
104. 4 15
105. C C 1MO 30MHz 9kHz G103 9kHz HH 101 Cx 1kHz C B 0 2mV H 101 C
106. 13 1 2 7 ci 13 2 13 3
107. 1kQ 102 500Q 1 Ri 100k2 1 Rr A 50ms 0 ep 2 201 102 7 A
108. ECG 27 5 1 2 150kHz 8 150kHz 130Hz 50Hz 60Hz
109. SN 28 4 ER 37 5 9g1 10 3N 0 5N 7 5N 0 5N 10N 0 5N 10 28 4 37 23 7 IEC60068 2 27 Ea a b
110. 11 3 6 ISO15223 11 4 9 6 11 5 9 7 11 6 9 3 1 11 7 11 8 9 9
111. 0310008 17 3 10 0 2 1 19 2 3 4 Lv 5
112. 108 6 1 2 2 ti 3 109 2 s 1 2 i 8 6 109 1 t s 1 1 110 t 110 2
113. 2 0mV 0 3mV 2 800ms 605 v 27 5 1 16 6Hz 150kHz G102 2 1MQ 30pE 20MHz D 1kQ F103
114. 28 8 2 d 22 28 12 28 14 28 15 22 1 33 500Wm 5 1 50 10 2MHz SMHz
115. 3 4 5 2 1 17
116. F102 kQ PVARP AV 103 1 1 g 28 4 54 E v F101 6 1 28 8 3 8
117. 28 8 2 v 3 13 1 1 b 1 g 2 mm 3 cm 4 om2 d 37C 2 500Q 1 6 1 1 2 3 4 5 7 8 9 e 37C 2C 500Q 1 1
118. ms 6 1 9 AV F103 119 5000 1 0 Rr 100k2 1 Rr C LE 119 AV 50ms 120 0 1 2
119. C D K 42 137 RT RE 4 1 e a e b c e d RR ET i a H 1 138
120. E m F IPG iPG 3 K IPG K iPG 30Q G104 82 G101 G101 68O 2W Ri 560Q Ra 82Q 1W CI 15nF Rs 1200 6 G102 G102 R 68Q 2W C 15nF gt 82Q W C2 180pF Rs 120Q 9 a 560Q Rs 56kQ a Rs 1MQ G G103 G103 G104 G104 C 120pF L 0 5mH 2 0 5 iD 5 83 C G
121. 4
122. 30Q 148 F 500Q RJ 148 49 148 149 149 F G 500Q R1 148 149 O MA 27 5 4 450MHz 3GHz
123. I I il v v 0 O 0 0 O A A T R A V V 1 V D D D D A V A V T D A V i S S A V A V NASPE BPEG PACE February 2002 Vol 25 No2 pp 260 264 1 V A D S _2 V A O
124. 0 V 11 S V Z 2 o5 AZ Rs 2 kQ 6 1 4 t 104 500Q 1 R Rr A Ri 100kQ 1
125. ms 7 2ms 0 2ms 45ms 1ms s 1ko Ar 103 80 G D C D K jpg C D E K IPG G102 81 BB R RR R y 5 2 G103 500kHz D
126. EE 7 7 Pit 20 Vi V 121 122 Q 623 Z F103 1kQ 2 x 25mm x d 30mm 0 8d 1 24 10 15mm 10
127. 10 1 63 23 2 23 5 23 3 23 5 1Ein Beitrag zur Sicherheit von Implantaten W Irnich et alia ISBN 3 88 314 870 9 ISSN 0932 3856 Schriftenreihe der Bundesanstalt fir Arbeitsschutz Dotmund 1989 23 3
128. 9 3 8 9 4 D 9 4 1 a b a c 9 37C 2 300Q 1 1
129. MLA 7 D 10V Ves Vins 85 101 MHz F Vep 10 2 58 20 3 58 30 438 40 4 62 50 4 75 60 4 82 70 4 87 80 4 90 90 4 92 100 493 150 4 97 200 4 98 300 4 99 400 5 00 86 5 00 2 ee Of RD
130. 9 5 23 9 6 ISO 8601 1988 9 7 R 9 8 9 9
131. 0 1pA 2rV 10 MD 1MQ 10uF 4 400MQO 500Q 1 Rr 125 125
132. sh 2mA ISO 5841 3 1992 0S 1 4 1 2 2 50KQ 100V 5V 0 1 5 10V 23 5 23 5 1 2 47 000 82 000 M
133. 104 6 1 2 2 t 1 5 10 105 1 2 105 t 106
134. 14 3 5 2 A d 14 4 3 3
135. ACG EA 6 1 3 EN 50061 1988 10 4 R ak R 6 2 2 C 101 61 C 101 x 9
136. jlml ATISO14708_2 5 S002 BRR CR O 1 2 O o oO 3 O o o 4 3 6 o 7 8 Os oO 9 O O On 10 11 O oO O 12 13 0 oO SO O Tt 15 4 15 1 15 2 16 16 1 16 2
137. 50Q RF 500kHz 20V 60 min 100Q R 126 9gl 126 0 10 1 5
138. A V VA VA D 3 8 2 DDD VA A V A V YA VA D 3 8 3 DDD V A A V A VA D 3 8 4 DDT V A AY
139. 132 F G 132 o 133 F G 10 1 134 F G 134 d 135 F G 10 1
140. 27 1 48 27 5 3 10MHz 450MHz G104 2 1 30O 450MHz 10 1MQ 1kQO F103 30Q 27 5 2 146 20MHz 50MHz 100MHz 200MHz 15 Vj F G
141. 3 44 3 45 3 46 3 47 4 5 2
142. 0 1 15 0 5 2 2mA 23 4 2 a 23 5
143. e 6 1 3 Z 1MQ F103 1kQ gm Hi 103 RS 103 5000 1 Rr Ri Rr A Ri 10k 100kQ R 19 Rs 100kO 1 30ms 0 8 R
144. C 1kHz C C 470nF C D 69 C C
145. 2 3 Il 0310008 7 8 10
146. 116 PVARP 1 117 2 117 PVARP 117 2 t 118 1 5 2 IPMARP 7 118 PVARP AV PVARP AV PVARP
147. 60 23 2 v 1 a
148. 19 3 2 1 1 2 1 3 4 8 3 5
149. 19 5 i 5 5 JTS T 14971 2 1 14 2 9 E eo JIST 14971
150. 2
151. A Y AV 1 conunited Ci D 3 9 VOO 76 D 3 10 VVD D 3 11 VAT AV
152. 138 F G HH 1 139 139 c 140 43 1 10 1 141 H 141 d
153. E 2 800ms 90 45 10 1 27 3 4 1 138 139 140 141 142 143
154. 84 1 RR G104 G EN D Vp Von 20 log m aoc gpc Bar 8st Coc 6 dB apc dB apc dB gz dB ggr dB cpc dB 147 30 F 50Q2 1dB 450MHz
155. ImT 0 1mT 10mT 1 10mT ImT 3 0 12cm 50 27 8
156. a x 28 6 13 4 8 27 14 14 1 ISO11134 ISO11135 IM 14 2
157. 200cm 150A m ms 20kHz 1 33V 27 3 150A m EN 45502 1 100kHz 140kHz 73 D D i 8 D 2 4 D 101 D 101
158. 72 272 27 5 27 8 kHz 100kHz 100 150A m rms IEEE 163A m 150A m 27 3
159. 1 2 1 7 2 1 6 0216002 Mo 2 2
160. R _ 10mV 0 2mV R SmV 0 1mV 21 124 R Z Q 7 7 1 14 1 7 2 8
161. lt a b o d 7 10kO 100kQ a gt 131 J 131 40 H FF G D
162. 1 11 11 a b 1 cm 2 mm f 3 mm 11 12 12 12 1 ISO11607 12 2 3
163. 1 1 10 4 11 11 1 11 2 ISO13223
164. 115 AV 2 AV ty ms 6 1 8 PVARP 116 50002 1 Ri Ry Rr 100kQ 1 6 1 2 2
165. 5000m s S00g oe 1ms d 3 1 6 28 8 2 d 24 24 1 25 25 1 1 70kP 3 5kP 150kP 7 CEE 26 26 1 262
166. M 959 129 2 130 C D 39 130 103 G 103 1 H Cx G101 10ms 130ms 4 1
167. V 10V 147 C D V 1 V 2 147 V D V 1 m F G 5mm 50mm
168. 1999 519 EC 519 99 EC 31999 20 EC 519 99 68 27 3 27 7 BC 519 99 EC 385 90 27 30MHz 2GHz
169. 4cm 0 131 10mT H 107 107 f H 1kHz lt f lt 100kHz 150A m 100kHz lt f lt 140kHz 150A m 100kHzf F d B P
170. DOO 1 A V DVI A V DVT A V VAT VDD VOO DDDR VVI VVT A V VVIC D 3 D 2 6 D 3 1 OOO D 3 2 A00 1 D33 AAD
171. 46 476 1 000 47 000 1 000 47 000 Weibull t 23 224 Weibull Weibull Bs 127 685 46476 47 908 65 MP35N ISO 5832 6
172. 2 6 3 9 3 10 6 1 4 3 11 3 12AV 6 1 7 3 13 3 14 9 1 6 1 1 3 15
173. 0302004 19 3 2 7 3 5 1 4 5 DEI 1 4 1 1 9 2 1 1 4 9 1 9 2 5 ER m 1 1
174. 3 29 1 3 30 Rc 6 2 1 3 31 Zp 6 2 2 3 32 Zs 6 2 3 3 33 3 34 3 35 BOS 3 36 EOS
175. 5 6 28U4EL i 7 1 7 2 1
176. 6 2 3 15 6 2 1 R R 8 Q 1 6 2 2 Z 50Q 2 d 50mm 0 84 1 24 10 33 5 LF Cr 121 19 121
177. 16 3 16 4 17 18 58 19 19 1 19 2 19 3 19 4 I 20 20 1 20 2 21 8 21 1 21 2 22 22 1 23 23 1
178. 18 19 19 1 2 1
179. yjyo 82 000 45 yyo 100g 82 000 66 DF 1 Weibul 81 697 1 000 t 23 6 oo 9 2
180. 13cm 2W 2cm Part 2 1 AAMI PC69 v 27 5 4 8 27 6 6
181. 70min 100 500o 1 ON ON 19 22 a 19 2 1 28 19 e 193 A TA EE
182. MM 2 tar 120 AV AV ty ms 6 2 28 8 37 2 9g 10 IMQ 102 102 6 2 1 5 6 2 2 15
183. 21 28 12 28 13 21 1 sR 8 21 2 HF 28 13
184. 1 169 JIS T14971
185. 114 3 t 1 3 H 2 i foi pei et te 114 2 tn ms 6 1 7AV 300Q 1 115 0 1 2
186. 23 2 23 3 23 4 23 5 23 6 23 7 eeeei 24 23 25 1 26 26 1 26 2 27 59 B 60 C C 1 AKA
187. A 1 2 ooomrotco 113 B t t ms 6 1 6 pr 6 1 4 104 5 6 1 2 2 t tp 5 10 105 107 3 t
188. 1 52 60 10 4 2 3 6 28 28 1 28 2
189. 111 111 2 2 t 1 2 a ri 110 A 1 2 1 2 1 3 ty B i a a NO 111 B 1 112 113 112 3 2 1 1 2 eee gt ES 112
190. 450MHz 100 13 M 95 VK v M 100 PP T 700ms 50ms V V 106 f 8 106 150kHz 10MHz Vi f Y 150Hz lt f lt 167kHz 6mV P1kHz 167Hz lt f lt 1MHz 1V 1MHz lt f lt 10MHz 1V 1MHz 60 150kHz 10MHz 4 V
191. 7 27 2 27 5 450MHz 450MHz 27 6 27 8 ICNIRP CENELEC ANSI IEC 27 5
192. 28 3 28 4 23 6 28 5 4 28 6 13 3 28 7 144 3
193. F101 A F102 o 20 101 t AAA IT 2402 1 1kQ 1 Ri e ms 6 V mA ms s min 1 6 1 2 ae eneg 1MQ F103
194. 1987 0 2285 0 0076mm 1 758MPa 172MPa 0 0610 0 0127 mm Rockwel C 44 4 0 2285 0 0076 mm PO 0 9144 0 0427 mm C 102 vitro MP3SN
195. d EN 50061 8 1 1 25ms 1 77g 0 7 ms 2rlz rms 1 86g EN 50061 EN 60068 2 64 5 5
196. requirements for safety marking and for information to be provided by the manufacturer 1SO14708 2 2005 Implants for surgery Active implantable medical devices Part 2 Cardiac pacemakers EN 28601 1992 Data elements ISO 8601 EN 45502 2 1 2003 Active implantable medical devices Part 2 1 Particular reduiremments for active implantable medical devices intended to treat bradyarrhythmia Cardiac pacemakers 60068 2 27 1993Basic environmental testing procedures Part lt Tests Test Ea Shock EC _ 60068 2 27 EN 60068 2 47 1999 Environmental testing Part 2 47 Test methods Mounting of componentsy equipment and other articles for Vibration impact and similar dynamic tests BC 60068 2 47 EN 60068 2 64 1994 Environmental testing Part 2 Test methods Test Fh broad band random digital control and guidance IEC60068 2 64 ISO 5841 3 1992 Low profile connectors GS 1 for implantable pacemakers ANSIAAMI PC69 2000 Active implantable devices Electromagnetic compatibility EMC test protocols for implantabie cardiac pacemaker and implantable cadioverter defibrillators ISO 10993 1 2003 Biological evaluation of medical devices Part 1 Evaluation and testing JHSO11134 1994 Sterilization of health care products Requirements for validation and routine control Industrial moist heat sterilization ISO 11135 1994 Medical Devices Validation and routine control of ethylene oxide sterilisation for 1 m
197. 125 a RL 50uV 6 3 16 4 i 29 28 8 2e 17 37 2C 19 3 2 NS
198. 0 1mT 1 1 2 27 7 10mT V 10mT 1mT 51
199. 16 6Hz 3GHz 67 Li
200. 22 6 1 5 6 1 6 3 23 3 24 1 3 25 2 3 26 3 27 3 28
201. 3 6 A V DV AV D 3 7 DVT AV D 3 8 A V 4 D 3 8 1 DD V A A V
202. D K 144 28 22 1 ee
203. edical devices ISO 14971 2000 Medical devices Application of risk management to medical devices JIST 14971 2003 17 3 30 0330001 GMP QMS 4 4 15 2 13 0213001 3 3 1
204. yo m vivo vivo C 102 MP3SNISO 3832 6 60 99 3 Weibull 47 908
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