植込み型心臓ペースメーカ等承認基準の制定について
Contents
1. 82. fr IST 14971
3. EN45502 1 62 16 3
4. 169 M 2
5. 11 9 13 1 2
6. 2
7. 15 2
8. 5 6
9. 27 ECG
10. vivo 0 64 6 00mm 0 10mm
11. 21 2 HF 28 13 30Q RF 500kHz 20V 60 min
12. C 68QO C H C 1kHz C
13. G102 2 1MQ 30Q 16 6Hz 140kHz 1 1 60 16 6Hz 140kHz 4 16 6Hz 20kHz f Vj 1V 20kH
14. DIN VDE 0848 3 1 1999 06 200cm 400cm
15. lt 27 2 27 3 27 4 27 5
16. E 2 800ms 90 45 10 1
17. 47 000 2Hz 9 90 2
18. t 4 5 vy
19. 500Q 1 R 33 5 hF Cr 123 R 123 15mm 5002 1 Rr 33 5 hF Cr
20. 7 2 7 1 2 1 14 1 0830001 7 3 30 8
21. 2 10 ELF C C
22. 27 5 27 2 27 3 27 4 ECG 27 5 1
23. 1 1 90 27 3 70
24. 2 ISO14708 1 _2000 Implants for surgery Active implantable medical devices Part 1 General requirements for safety marking and for information to be provided by the Tmanufacturer ISO14708 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 implantable medical devices intended to treat bradyarrhythmia Cardiac pacemakers _60068 2 27 1993Basic environmental testing LA Part 2 Tests Test Ea Shock IEC 60068 2 27 EN 60068 2 47 1999 Environmental testing Part 2 47 Test methods Mounting of components equipment and other articles for vibra
25. 2 1 16 4 19 1 19 3 2 2 1 19 2 3
26. 16 16 1 16 2 0 1pA 2rV 10 MD 1MQ 10hF 4 400MQ
27. 28 22 1 1kHz 2 0mV 0 3mV 2 800ms 90
28. 3 0810008 17 3 10 au
29. 3 4 8 5
30. 300Q 1 Ri 125 125 125 RL 30prV 16 3 16 4 29 28 8 2 e
31. 4 5 6
32. 3 5 3 6 2 6 1 1 3 7 2 6 1 1 3 8 2 6 1 1 3 9 3 10 6 6 1 4 3 11
33. 2 1 14 8 2 1 14 8 2 1 23 3
34. 169 ei 9 0 10
35. yio 82 000 43 yyo 100g 82 000 66 DF 1 Weibull 81 697 1 000 t 23 6
36. 20mm 30 1 50mm 200mm 34 2 100V 5V 0 1 5 15
37. 3 1977 2 9 19 3 0m 100 mL 25rm 5 mL 14 3 9 Pp
38. 28 24 57 ATISO14708 2 ISO14708 2 1 2 3 O1OI LO1O1 OIO1I 4 yt 5 6 7
39. 3 1 4 9 6 2 1 4 1 1 9 2 1 1 7 2
40. 28 19 a a 1 2 19 2 2 3 b 56 300O 1 o 19 2 1 d
41. 37C 5C 9g 10 SN 0 5N 7 SN 0 5N 10N 0 5N 10 28 4 37 23 7 IEC60068 2 27 Ba 8 5 5000mys 00g c 1ms 9 3 1
42. 3 12AV 6 1 7 3 13 3 14 6 1 1 3 15 3 16 3 17
43. 27 5 4 27 6 1 1mT 10 27 7 10mT NG
44. 13 3 X X 14 2
45. G101 G 103 2 IMQ 30Q H 2 1 1V 16 6Hz 20kHz 1 60 16 6Hz 20kHz 4 2 500kHz 130Hz 129
46. D 2 D 3 1 OOO D 3 2 A0O D 3 3 AAI D 3 4 AAT
47. 5 5N
48. 4 5 6 ET 2 1 27
49. 28 19 e 19 3
50. 2 E 3 1
51. MP35N MP35N 47 000 CEN CENELEC JWG AIMD EE 21
52. b e 19 2 1 3 28 19 e
53. 6 1 3 EN 50061 1988 10 4 Ri Ri 6 2 2 C 101 61 C 101 x 9
54. i 27 8 72 27 2 27 5 27 8
55. kHz 100kHz 100 150A m rms IEEE 163A m 150A m 27 3 200cm 150A m rms 20kHz 1 33V 27 3 150A m EN 45502 1 100kHz
56. 53 D 2 1 2 c 28 8 2 a a 1 2 3 nm
57. 67 27 2 27 5 3 1kHiz 0 3mV 2 0mV
58. 2 3 2
59. er 4 Q 8 nm ce 78 4 E102 79 RI03 4 80 ms 7 2ms 0 2ms T 15ms 1ms s 1kQ G D C D
60. 27 4 27 2 27 3 27 5 167kHz 27 5 167kHz 1
61. 10 1 63 23 2 23 3 23 3 23 5 0 LT J IEin Beitrag zur Sicherheit von mplantaten W Irnich et alia ISBN 3 88 314 870 9 ISSN 0932 3856 Schriftenreihe der Bundesanstalt ftir Arbeitsschutz Dotmund 1989 23 3
62. 14 4 15 15 1 28 13 2
63. 20 2 21 22 27 28 13 28 14
64. 19 2 1 103 2 30 103 2 SV 0 5ms 70min 100 5000 1 ON ON 19 2 2 19 2 1
65. O 74 D 4 4 D 102 D 102 AAI AAT AOO DDD A V DOO A V DVI A V DVT A V VAT VDD VOO VVI VVT SSI DDDR A V VVIC D 3
66. 3 1 4
67. 9 9 9 10 9 3 9 4 9 11 10
68. 3 39 3 40 RRT 3 41 3 42 3 43 3 44 3 45 3 46 3 47
69. 28 8 37 2 500Q 1 101 101 6 1 1 5 6 1 1 6 5 0 2 6 1 1 6 1 1 0 5 6 1 2 10 6 1 3 lt 1MQ 10 6 1 4 109 6 6 1 5 6 1 6 6 1 8 10 AV 6 1 7 6 1 9 5 1MQ
70. 8 ISO15223 9 11 13 8 1 3 8 2 s 9 9 1
71. 2 3 8 28 28 1 28 2 28 3 28 4
72. V 106 f 106 150kHz 10MHz Vi f V 150Hz lt f lt 167kHz 6mV IKHz 167Hz lt f lt 1MHz 1V 1MHz lt f lt 10MHz 1V 1MHz 60 150kHz 10MHz 4 V D 27 5 1 48 27 5 3 10MHz 450MHz G104 2 1 50Q 450MHz 10 2
73. a d EN 50061 8 1 1 25ms 1 77g 0 7 m s Hz rms 1 86g EN 50061 EN 60068 2 64 5 5
74. 7 2 1 19 3 13 2 3
75. JIS T 14971 USO14971 EN 1441 C 2 6 37C 2C
76. 0 1mV 0 0 3mV 2 0mV P VDD
77. 38 272 27 8 6 1 28 8 2 d 28 22 1 27 4 27 5 1 27 2
78. 58 19 19 1 19 2 19 3 19 4 6 9 9 20 20 1 20 2 21 21 1 21 2 22 22 1 23 23 1 23 2 23 3 23 4 23 5 23 6 23 7
79. H 101 Cx KHz C B 0 2mV H 101 C 84 1 E G104 G m D 1 Vp m Vose
80. 44 27 4 3 G102 2 IMQ lkQ 50Q 103 16 6Hz 167kHz
81. 5 3 27 3 28 3 29 3 30 Rc 6 2 1 3 31 Zp 6 2 2
82. 20 v 5y 2mA ISO 3841 3 1992 GS 1 4 1 2 2 50KQ 100V SV 0 5 10V 23 5 23 5 2 47 000 82 000
83. 10cm 0 scm 100g Sg 82 000 2Hz 9 45 2 23 6 5N 28 4
84. 10mT 1mT 10mT 5 27 8 12cm 50 4cm 9 8
85. 3 32 Z 6 2 3 3 33 3 34 3 35 BOS 3 36 BOS 3 37 3 38 PSP
86. 5 BC60068 2 14 1986 Nb 10C 3 3 2 1 0 2 10C 3 55 2 27 27 1
87. 11 2 ISO13223 11 3 SO15223 11 4 9 6 11 5 9 7 11 6 i 9 3 11 7
88. 169 JIST14971 lt 5 169
89. 23 23 1 23 2 TEC 60068 2 47 IEC60068 2 64 Fh 8 5Hz 500Hz bp 0 7 m s 27Hz e SHz 500Hz 9 3 30 28 8 2 d 1 23 3
90. JST 14971 IS05841 8 9 JIST 14971
91. 20kHz 500kHz 2 50hA TEC 60601 2V 2
92. 76 D3 10 VVU D 3 11 VAT AV
93. 28 12 20 1 20 2 1 RCL C 330gF 16 5pF L 13 3mH 0 13 mH RL RG 10Q 02Q Rr Q R Q Rg V 140 V 7V 300Q 6Q
94. 12 12 1 H ISO11607 3 19 2 26 12 3 10 3 13 13 1 13 1 1
95. V 105 f 105 16 6Hz 150kHz V 16 6Hz lt f lt 1lkHz 2mV 2mV 71kHz 6mV 1kHz 144 D K H Cx G102 16 6Hz 150kHz 60 4 Vj D
96. 22 9 2 9 3 9 4 D 9 4 1 1 a b a
97. 28 22 1 47 27 5 2 150kHz 10MHz 27 5 1 f 150kHz 10MHz 130Hz 100ms T 146 146 150kHz 450MHz 100 13 M 95 M 100 mp T 700ms 50ms Vpp
98. S R 0 V S V Z Lo5 2 2 lt R 2 Rs 2 kQ 6 1 4 1 104 500Q 1 Rr
99. EC 385 90 27 30MHz 2GHz 7 MHz
100. 2 1 127 110 6mm 0 imm 127 35 127 0 90
101. 23 6 28 5 28 6 13 3 28 7 14 4 28 8 1 8 1
102. 37 5C 9g 500mmz 37C 5 C 9g 100V 2mA 10 3 20 5N 1
103. 7 8 1 2 JST 14971
104. 1 1 3 18 3 19 3 20 6 1 3 3 21 6 1 2 3 22 6 1 5 6 1 6 3 23 3 24 1 3 25 2 3 26
105. 10 6 1 1 3500Q 1 R 101 1 D Amax 3 1 F101 A
106. F102 20 Fe mm 101 tp 240Q 1 1kQ 1 Rr ms V mA ms e mn 6 1 2 eo eneg 1MO 103
107. 116 PVARP t 117 1 2 PVARP 1 117 PVARP 117 2 118 1 H 2 PVARP 118 PVARP AV PVARP AV
108. 11 2 3
109. A V VA V A D 3 8 3 DDD V A A V A VA D 3 8 4 DDT V A AV A V AV conunitted D 3 9 VOO
110. 4 1 a b c d 10kQ 100kQ a 131 F G 131
111. 17 37 2 19 3 18 19 19 1
112. 51k 1 S S T S T 300Q 1 2 6 1 2 lmT 0 1mT
113. 1 2 1 7 2 1 6 0216002 2 2 8
114. _ 2 150kHz 150kHz 130Hz 50Hz 60Hz 95 71 2 3kHz 1MHz EC S19799 100kHz
115. D 3 12 VDD AY D 3 13 VVT 7 k E 101
116. 27 2 Starmer Watson 1 25 2mm 50 60Hz rms 50kA 1 1kHz 1 20kHz
117. 124 R 10mV 0 2mV R smV 0 1mV 21 124 R Z Q 7 7 1 14 1 7 2
118. 100Q R 126 9g Sl 126 10 1 5 28 8 2 d
119. OE 19 4 ISO14155 19 3 5 31 20
120. PVARP AV e 37C 2C 500O 1 6 1 9 g 28 4 34 28 8 3 a bj c 1 cm 2 mm 3
121. 27 2 27 4 27 5 27 3 27 3 0 27 8 27 3 kHz
122. Z Pdt 2 Rs i dt 0 20 Vi V 121 122 Q 6 2 3 Z F103 1kQ 2 d x 25mm x d 50mm 0 8d 1 2d4 10 1Smm 10
123. a 2 1 V 2 A 3 S b D 13 1 2 5 13 2 6
124. 15 2 13 0213001 i 3 3 1 3 2 3 3 3 4
125. 13 3 1 X 28 6 13 4 27 14 4 1
126. 2 1 V 147 D V 1 m F G Smm 50mm 50Q 300Q Rr 148 49 148 F
127. 275 28 22 2 28 23
128. 68Q 2W 15nF R2 822 1W C2 180pF Rs 120Q C II Rs 5600Q 5 Rs 56kO 1MQ _ G103 G03 4 7kO G104 G104 56kQ R2 C 120pF L 0 5mH 2 0 5 5 83 C G C C 1MQ 30MHz 9kHiz Gi103 9kHz
129. 2 1 15 2 2 1 20 1 21 22 25 26 27 0 JIST 14971 6
130. v ANSWAAMI PC69 ANSI AAMI PC69 2 15cm 2W 2cm Part 2 1 AAMI PC69
131. 40 132 F G we CIC RC 132 c 133 F G 10 1 134 G 134 d
132. 24 10 3 10 mL 1 10 4 5 11 11 1
133. Weibull B 127 685 46 476 47 908 i 65 MP35N ISO 5832 6 1987 0 2285 0 0076mm 1758MPa 172MPa 0 0610 0 0127 mm RockwellC 44 4 0 2285 0 0076 mm Ct 0 9144 0 027 mm C 102 yzo
134. 106 107 1 2 5 te 106 te 1 2 jt 107 te t ms 6 1 5 G 108 300Q 1 Rr Rr A
135. 140kHz 73 D D 1 D 2 4 D 101 D 101 I II IV V O 0 O 0 O A A T R A V V I V D D D
136. 20V Entwurf Juni 1985 DIN VDE 0750 Teil 9 60 23 2
137. _9 12 10 10 1 10 2 2 30 2C 93 3
138. 2 1 28 JIS T 14971 16 43 2
139. 28 15 28 16 11 28 17 28 18 5
140. ISO11134 ISO11133 14 2 9g1 nmL cm2 5 0 5 8 18 37 2
141. Rr A Rr 100kO 1 1 2 104 6 1 2 2 t 5 10 105 1 2 a 105 t
142. mm fFr 4 mm 5 mm 6 Gmm 7 6 2 1 Q 2 3 Q e 28 4 28 8 4 a b 23 6 a c
143. 1kQ 102 300Q 1 Rr 100kQ 1 Rr A 30ms 0 e 201 10 102
144. 60 99 3 Weibull 47 908 46 476 1 000 47 000 1 000 47 000 Weibull t 23 5 224 Weibull
145. 169 JIST 14971 3 169 4
146. 0 3 2 2mA 23 4 2 a 23 5 2 1
147. LDS rin H 1 138 138 b F G I 139 139 c 140 43 H 1 10 1 141
148. 8 9 10 11 12 13 14 14 1 14 2 14 3 14 4 oleloleloloi lo O08 OO oleloleljololelo OI IOi IOIOI O08 15 15 1 15 2 16 16 1 16 2 16 3 16 4 17 1 18
149. x 12 yzo yyo vivo C 102 MP3SNIISO 5832 6
150. C 470nF C D 69 C C C C C 27 1 27 2 27 8
151. JIST 14971 0810008 17 3 10 1 0 2 1 19 2 2
152. 2 1 16 4 20 21 2 1 19 2 2 3
153. A 1 2 Hal ly 113 B 1 t ms 15 6 1 6 tpr 6 1 4 104 6 1 2 2 t tp 5 10 105 gt 107 3 t
154. 4 0 1V 144 C D K 144 28 22 1
155. 20 log m anc apc Bar apij Cpc 6dB apc dB apc dB aar dB ggy dB epc dB 147 G 30Q F 50Q 1dB 450MHz D
156. K ipg K C D E K IPG G102 81 A oo 5 0 Ri 5 Rs o B f Ci G Co G103 S00kHz C D E E F IPG G IPG K IPG KK IPG EB K 50Q G104 82 G101 G101 68O 2W 560Q 82Q 1W Cr 15nF Rj 120Q C H G102 G102
157. mm c 9 5 23 9 6 ISO 8601 1988 9 7 9 8
158. IMQ 1kQ F103 S0Q 27 5 2 146 20MHz 50MHz 100MHz 200MHz 15 Vo V F G 10V 147 C D V 1 V
159. 1 6 0216002 4 2 1 7 3 3 1 0331012 5 pi 1 1 1 2 28 1439 1
160. 23 3 21 2 500kHz 20V Dr W nich 37 43C 5V rms 14V 20Vpp 14V p
161. c d 37 2 500Q 1 1 2 3 4 3 6 AV 1 mm 8g 9 4 2 a b 1 cm 4 p 2 mm Fr 3
162. 149 149 FF G 500Q RJ 148 149 27 5 4 450MHz 3GHz 50Q 50Q 450 600 800 825 850 875 900 930 1610 1850 1910 2430 3000MHz 30dB
163. H 1 140 141 d 142 F G H 1 10 1 143 HH 1 10kO E 143
164. DVT AV D 3 8 A V 4 D 3 8 1 DD V A A V A V VA VA D 3 8 2 DDD VA A V
165. 115 AV AV by ms 16 6 1 8 PVARP 116 500Q 1 Ri Rr Rs 100kO 1 6 1 2 2
166. mm 28 8 5 28 9 28 10 28 11 55 28 12
167. Rr 100kQ 1 13 108 6 1 2 2 2 5 10 2 s 1 2 SS Er 109 1 th s 1 1
168. 1mT 27 6 10mT 27 7 27 8 EMT 16 6Hz 3GHz 4
169. A e 6 1 3 2Z 1MO 103 1kQ J 103 103 500Q2 1 Ri R Rr A R 10kQ 100kQ Ri 1 Rr 100k2 1 50ms 0
170. 6 28 8 2 24 24 1 25 25 1 i 0 1 70kP 3 SkP 150kP 7 5kP 26 26 1 26 2
171. EC rms rms 5 mns 5 6 27 5 1MHz 10MHz 10MHz 10MHz 450MHz 27 5 3 50Q 27 5 4 27 5 4
172. KS N v 169 2 1 14 4 19 5
173. 1 2 10 1 27 3 4 1 138 139 140 141 142 143
174. 13 1 1 o b 1 2 3 4 g mm cm e cm d 37C 2C 500Q 1 6 1 1 2 3 4 5 6 7 8 9 101 102 kQ F103
175. 151 107 107 f H 1kHz lt f lt 100kHz 150A m 100kHz lt f lt 140kHz 150A m 100kHzf 1 52 60 10 4
176. 75 D 3 5 A V DOO A V D 3 6 A V DVD AV D 3 7
177. OO 24 23 25 1 26 26 1 26 2 27 39 60 C C 1
178. 11 8 9 9 25 1 9 11 10 a 9 4 b ON OPE e d 37 C 2 500Q 1
179. 2V M 95 129 2 130 C D 39 130 103 G103 K 1 H Cx G101 10ms 150ms
180. 0302004 1 9 3 2 resaaraean 3 5 1 4 5 1 4 1 1 9 2 1 1 4 9 1 9 2 5 2 8 I VD 1 1
181. 2 1 17 1 4 2 1 16 2 2 2 1 16 2 _3
182. PVARP ms 6 1 9 AV F103 119 500Q 1 Rr 100kQ 1 R C 119 AV 30ms 120 18
183. 1 2 3 4 5 6 AV e g 11 11 a b 1 cm 6 2 mm fr 3 mm 11 12
184. 37C 2 500Q 1 1 2 3 4 5 6 19 2 e 28 20 3 28 21 10 eS 28 22 1
185. 19 121 1smm 10 10mm 122 33 5 pF Cr 1 122 65 5 4V 0 1V 0 5ms 0 05Sms 10Q23 2 RR
186. 0 3mV 0 3mV 2 0mV EMI 4 8 16f 27 2 27 5 4S0MHz 450MHz 27 6
187. 128 0 5mm ISO 5841 3 GS 1 2 ISO 11318 DF 1 4 36 128 45 2 128
188. 10V Vs 85 1101 MRz F Wy 10 2 58 20 3 58 30 4 38 40 4 62 50 4 73 60 4 82 70 4 87 80 4 90 90 4 92 100 493 130 4 97 200 4 98 300 4 99 400 3 00 450 3 00 86 2 et 1
189. 135 F G 10 1 136 F G 135 41 136 K 232Q 1 104 2 130Hz 50 A 104 f 16 6Hz lt f lt 1kHz 50hA pe 50hA kHz 27 3
190. 22 28 12 28 14 28 15 22 1 33 500W m 5 1 50 10 2MHz SMHz
191. 27 5 1 16 6Hz 150kHz G102 2 IMQ 30pF 20MHz D 1kQ F103 50Q 9 f 16 6Hz 130kHz 100ms ON 600ms OFF 145 46 HE 145 16 6Hz 150kHz Vop
192. 27 3 4 1 138 139 140 141 142 143 2 2 27 5 5
193. D A V A V GT D A V S S A 4A VW NASPE BPEG PACE February 2002 Vol 25 No2 pp 260 264 1 V A D S 2 V A O D S 3 II
194. 114 3 t 1 2 1 6 pi 114 2 tp ms 6 1 7AV 300Q 1 115 3 2 jy i
195. 27 8 ICNIRP CENELEC ANSI IEC 27 5 1999 519 EC 519 99 EC 519 99 20 EC 519 99 uri 1 68 27 3 27 7 EC 519 99
196. JIST 14971 JIST 14971 6 y 2 1 6 23 6 7 v 1
197. gt EE JIST 14971 2 1 14 2 6 JST 14971 8
198. 12 3 28 528 12 10 5 No21 Q amp A 1 1
199. 6 2 2 15 6 2 3 15 6 2 1 R R O 6 2 2 Z 30Q 2 d 50mm 0 8d 1 24 10 33 5 6uF Cr 121
200. 1 9g 20 20 3 60 2 0 2 1 RCL 140V 20 s 2 21 28 12 28 13 21 1
201. 1 1 2 27 7 10mT 10mT lmT 31 1mT 0 imT 10mT 1
202. 1 2 MM 5 hy 3 ar 120 AV AV ty ms 6 2 28 8 37 2C 9g 10 6 IMQ 102 102 6 2 1 5
203. 2 5 7 1 6 2 9 8 1 200 208 204 206 E 19 3 2 ta 1 1
204. 110 ti 110 2 11i 11 2 2 t 1 2 3 1 AN a 3 110 A 1 2 a ty i 111 2 1 112 113 112 3 2 1 3 1 1 je 2 112
205. 4 5 6 6 1
206. AAMIPC69 6 AAMI PC69 6 5 30 27 6 1mT 150 103 51kQE 1 500Q 1 ImT 0 1mT 00Q 1 Rr S T 150 S
207. tion impact and similar dynamic tests IEC 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 IS 1 for implantable pacemakers ANSIAAMI PC69 2000 Active implantable devices Electromagnetic compatibility EMC test Particular requirements for active protocols for implantable cardiac pacemaker and implantable cadioverter defibrillators ISO 10993 1 2003 Biological evaluation of medical devices Part 1 Evaluation and testing ISO 11134 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 inedical devices ISO 14971 2000 Medical devices Application of risk management to medical devices JIST14971 2003 5 17 3 30 0330001 GMP QMS 4 4
208. z 140kHz f Vpp 1V m 20 kHz 137 C D K 42 137 4 1 a b D c
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