Page 1 Page 2 全性試験の基本的考え方につし丶て(以下「生物学的
Contents
1. 19 4 ISO141552. 47 000 2Hz 6 90
3. 2 2 27 5
4. 23 23 1 23 2 IEC 60068 2 47 C60068 2 64 Fh a 5Hz 500Hz b 0 7 mys 27Hz e SHz 00Hz d 3 30
5. 19 2 1 3 28 19 e 19 2 1 103 2
6. 9 9 1 9 2 9 3 9 4 D
7. G102 2 IMO 30Q 16 6Hz 140kHz 1 1 60 16 6Hz 140kHz 4 16 6Hz 20kHz f V 1V 20kHz 140kHz f Vep 1V m 20 kHz m 137
8. E 2 800ms 90 45 10 1 27 3 4 1 138 139 140 141 142 143
9. IEC60068 2 14 1986 Nb _ 10 3 55 2 1C 02 10C 3C 55C 2C 27 27 1
10. v 28 22 2 28 23
11. G101 G103 2 1MQ 50O H 2 1 IV 16 6Hz 20kHz 1 60 16 6Hz 20kHz 4 2 500kHz 130Hz 129
12. 10cm 0 5cm 100g 5g 82 000 2Hz 9 45 2 23 6 N
13. 30Q 50Q 450 600 800 825 850 873 900 930 1610 1830 1910 2430 3000MHz 30dB AAMI PC69 6 AAMI PC69 6 5 30 27 6 1mT 150 F F103
14. 116 500Q 1 Rr Rr Rg 100kQ 1 6 1 2 2 116 PVARP t 117
15. 28 13 30Q RF 300kHz 20V 60 min 100c R 126 9g 126
16. 28 19 a 1 2 19 2 2 3 b MIEIEIESEIEEIMSGEE 300O 1 c 19 2 1 9 37 2 500Q 1
17. 28 8 37 2 S000Q 1 101 101 a 6 1 1 5 6 1 1 5 6 1 1 6 1 1 6 1 2 6 1 3 lt 1MQ 6 1 4 6 1 5 6 1 6 6 1 8 10 AV 6 1 7 6 1 9 5 1MQ
18. 10 1 27 3 4 1 138 139 140 141 142 143 28 22 1 47 27 5 2 130kHz 10MHz 27 5 1 f 150kHz 10MHz
19. 3 1977 2 9 19 3 0gm 100 mL 25nm 5 mL 14 3 3 b co
20. 28 24 37
21. 2 21 28 12 28 13 21 1 21 2 HF
22. 20 2 21 22 27 28 13 28 14
23. 28 8 37 2 9gI 10 IMO 102 102 6 2 1 6 2 2 6 2 3 6 2 1 R R Q 6 2 2 Z 30Q
24. 28 4 23 6 28 5 28 6 13 3 28 7 i 14 4
25. 142 F G H 1 10 1 143 H 1 10kQ 100kO F G 7 H 7 J 142 143
26. 3 17 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
27. 12cm 50 4cm 151 H 107 f 107 H 1
28. 6 1 4 3 11 3 12AV 6 1 7 3 13 3 14 1 6 1 1 3 15 3 16
29. 30Q 148 F 3500 Rr 148 49 149 149 F G 3500Q Rr 148 149 27 5 4 45S0MHz 3GHz
30. 3 3 3 4 3 5 3 6 6 1 1 3 7 2 6 1 1 3 8 2 6 1 1 3 9 3 10
31. 28 22 1 1kHz 2 0mV 0 3mV 2 800ms 90 27 5 1 16 6Hz 150kHz G102 2
32. V 10V 147 C D V 1 V 2 1 147 Vp D V 1 m F G Smm 50mm
33. 38 27 2 27 8 6 28 8 2 d 28 22 1 27 4 27 5 1 27 2
34. 9 11 10 9 12 10 10 1 10 2
35. 14 4 15 15 1 15 2
36. 11 7 11 8 9 9 25 11 9 11 10 a 9 4 b TON OFF c
37. 16 16 1 16 2 0 1nA 2uV 10 MD 1MQ 10uF 4 400MO
38. 107 1 2 1 106 te 1 2 R i 107 te t ms 6 1 5 G 108 300Q 1 R R A Rr 100k2 1 108 6
39. 28 4 37C 9gI 10 SN 0 5N 7 5N 0 5N 10N 0 SN 10 28 4 37 23 7 IEC60068 2 27 Ea 8 b
40. 2 30C 2 93 3 10 3 10 mL 1 10 4
41. 11 11 1 11 2 ISO13223 11 3 ISO13223 11 4 9 6 11 5 9 7 11 6 9 3
42. 10 1 136 F G 135 41 136 K 232Q 1 104 2 130Hz 50A 3 0 as 50nA 50LA kHz 27 3
43. 2 100V V 0 1 5 15 0 3 2 2mA 23 4 2 a
44. a 2 1 V 2 A 3 S b D 13 1 2 13 2
45. 103 100 19 2 2 19 2 1 28 19 e 19 3
46. 60 10 4 2 3 28 28 1 1 28 2 28 3
47. 10 0 2 0 5 10 10 10 6 1 1 300Q 1 R 101 1 D Amax 3 1 Fi101
48. 1kQ 102 300Q 1 R 100kQ 1 Rr A 50ms 0 e 201 102 A
49. 51kO 1 300Q 1 1mT 0 1mT 00Q 1 Rr S T 150 S S1kQ 1 S S S T 300O 19
50. c mm 28 8 5 28 9 5 28 10 28 11 55 28 12
51. R Z Q 7 7 1 14 1 7 2 8 ISO15223 9 11 13 8 1 8 2
52. 3 38 PSP 3 39 3 40 RRT 3 41 3 42 3 43 3 44 3 43 3
53. 13 3 X 28 6 13 4 27 14 14 1 ISO11134 ISO1
54. 10mm 122 33 5 uF Cr 122 65 4V 0 1V 0 5ms 0 05ms 10Q 2 R Z i hd Z zz 0 20 Vi V 121 122 Q 6 2 3 Z F 103 1kQ
55. 2 128 0 5mm ISO 5841 3 IS 1 2 ISO 11318 DF 1 4 128 45 2 128
56. 28 8 1 3 1 53 D 2 b 1 2 c 28 8 2 a 1 2
57. 23 5 2 2 1 127 110 6mm 0 imm 127 35 127 9 90
58. 132 F G 132 c 133 F G 10 1 134 F G J F Cc J i 133 F G J 134 a d 135 F G
59. 2 d 50mm 0 8d 1 24 10 33 5 hF Cr 121 19 1 C 5 121 1smm 10
60. 1 2 ISO14708 1 _2000 Implants for surgery Active implantable medical devices Part 1 General reduirements for safety marking and for information to be proyided by the manufacturer ISO14708 2 2005 hmplants for surgery Active implanfable medical devices Part 2 Cardiac pacemakers EN
61. C D K 4 1 a b c d a H 1 138
62. 2 6 1 2 1mT 0 1mT 1 1 1 2 27 7 10mT 10mT ImT
63. kO 6 103 7 PVARP 8 AV 9 e 37C 2C 300o 1 6 1 f f g 28 4 28 8 3 a b c
64. 5000 1 R 125 125 125 Rr 50uV 16 3 16 4 29 28 8 2 e 17
65. 9 7 9 8 9 9 v 9 10 9 3 9 4
66. 2 d x 25mm x d 50mm 0 8d 1 2d 10 15mm 10 500Q 1 Rr 33 5 pF Cr
67. V D 27 5 1 27 5 3 10MHz 450MHz G104 2 1 50Q2 450MHz 10 2 MQ 1k lt F103 30Q 27 5 2 146 20MHz 50MHz 100MHz 200MHz 15 V F G
68. er 6 1 3 Z 1MO F 103 1ko 103 103 300Q 1 R R Rr A Ri 10kO 100kQ R 1 Rr 100kO 1 30ms 0
69. 2V M 959 129 2 130 C D 39 130 103 G103 K 1 Cx G101 10ms 130ms 4
70. 6 2 1 3 31 Zp 6 2 2 3 32 Z 6 2 3 3 33 3 34 3 35 BOS 3 36 EOS 3 37
71. 1 5 2 PVARP W 117 PVARP 117 2 t 118 1 5 2 iPMRP 118 PVARP AV PVARP AV PVARP ms 6 1 9 AV F 103
72. 9 4 1 a b a c 37C 2 500O1 1 2 3 4 6 AV e mm
73. 28 15 28 16 11 28 17 28 18
74. d 37C 2 500Q 1 1 2 3 4 5 6 AV e g 11 11 a b 1 cm 2 mm Fr 3 mm
75. 8 9 4 2 a b 1 cm 2 mm Fr 3 mm 9 5 23 9 6 ISO 8601 1988
76. Q R Q R V 140 V 7V 3000 6Q 1 9g 20 2 0 3 60 2 0 2
77. 10 1 5 28 8 2 d 22 28 12 28 14 28 15 22 1 33 500W m 5 1 30 10 2MHz SMHz
78. 2 ms 6 1 7AV 300O 1 115 1 2 a i lr 115 AV AV tuy ms 6 1 8 PVARP
79. S R 0 V 11 S V Z z HO05 RA Z Rs 2 ko 6 1 4 t 104 500Q 1 R1 Rr A
80. ms 15 6 1 6 tpr 6 1 4 104 6 1 2 2 t 6 5 10 105 107 3 t 114 3 t 1 H 2 HE SE 114
81. 130Hz 100ms T 146 146 150kHz 450MHz 100 13 M 959 100 T 700ms 50ms Vep V 106 f 106 150kHz 10MHz Vp 6mV 167Hz lt f lt 1MHz Sm 60 150kHz 10MHz 4
82. 209 3N 1 20mm 30 1 S0mm 200mm
83. Z 1 IT 138 b F G H 1 139 T F G i J 139 c 140 43 H I 10 1 141 H 1 H 1 MC 140 141
84. 1 cm 2 nm 3 mm Fr 4 mm 5 mm 6 mm 7 d 6 2 1 Q 2 3 e 28 4 28 8 4 a b 23 6
85. 27 4 G102 2 IMQ 1kQ F103 50Q 16 6Hz 167kHz 4 0
86. Rr 100kO 1 R20 ET 104 6 1 2 2 t t 5 10 105 1 2 5 105 t 106
87. 28 8 2 23 3 37C SC 9g1 500mm 37 C 5 9gl 100V 2mA 10
88. 31 1mT 0 1mT 10mT 1 10mT ImT 10mT 5 27 8
89. 19 5 2 5V 0 5ms 70min 31 20 28 12 20 1 20 2 1 RCL C 330zF 16 5F L 13 3mH 0 13 mH RL RG 100 0 20 Rr
90. 37C 2 19 3 18 19 19 1 8
91. 3 24 1 3 25 2 3 26 3 27 3 28 3 29 3 30 Rc
92. 0330001 GMP QMS 4 4 13 2 13 0213001 f 3 3 1 3 2
93. 144 C D K H Cx G102 16 6Hz 130kHiz 60 4 V D 1 2
94. 1 2 3 4 5 6 19 2 e 28 20 28 21 28 22 1 27 5
95. mm 3 13 1 1 b 1 2 mm 3 cm o cm d 37 2 500Q 1 6 1 1 2 101 F102 3 4
96. IMQ 30pF 20MHz D Ik lt F103 30Q f 16 6Hz 150kHz 100ms ON 600ms OFF 145 100 MM 145 16 6Hz 130kHz Vpp Vp 105 f 105 16 6Hz 150kHz Vo 16 6Hz lt f lt 1kHz 1kHz lt f lt 3kHz 2mV D1kHz 3kHz lt f lt 130kHz 6mV 1kHz
97. 1 a e b lt c d 10k2 100kQ a 131 F G F G J 1331 D
98. t 1 2 110 A 1 2 ee 111 B 1 112 ii 113 112 3 2 1 2 8 es 112 A 1 2 113 B 5 t t
99. 1V 144 C D K 144 28 22 1
100. A F102 20 101 2400 1 1kQ 1 RL s ms lt V mA e ms e min 6 1 2 e eseg 1MO F 103
101. 123 R RR Cr R 123 15mm 300Q 1 Rz 33 39 nF Cr 124 R 10mV 0 2mV R SmV 0 1mV 21 124
102. 1 2 2 ti 5 10 2 s 1 3 109 1 ti s 1 1 110 t 110 2 111 111 2 2
103. 46 3 47 4 3 6 6 1
104. 5000m s 500g c 1ms 9 3 1 6 28 8 2 d 24 24 1 25 25 1 1 70kP 3 SkP 150kP 7 5kP 26 26 1 26 2
105. _ 11 12 12 12 1 ISO11607 12 2 12 3 10 3 13 13 1 13 1 1
106. 1135 14 2 9g1 mL cm2 5 0 5 8 18 37 2C
107. 119 500Q 1 Rr 100k2 1 Rr C 119 AV 50ms 120 im 1 ee 0 2 1 os tie 120 AV AV ty ms 6 2
108. 28601 1992 Data elements ISO 8601 EN 45502 2 1 2003 Active implantable medical devices Part 2 1 Particular requirements for aciive implantable medical devices intended to treat bradyarrhythmia Cardiac pacemakers 60068 2 27 1993Basic environmenal testing procedures Part 2 Tests Test Ea Shock EC 60068 2 27 EN 60068 2 47 1999 Environmental testing Part 2 47 Test methods Mounting of components equipment and other articles for vibration impact and similar dynamic tests EC 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 6 ISO 5841 3 1992 Low profile connectors IS 1 for implantable pacemakers ANSI AAMI PC69 2000 Active implantable devices Electromagnetic compatibility EMC test 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 Deyices Validation and routine control of ethylene oxide sterilisation for medical devices ISO 14971 2000 Medical devices Application of risk management to medical devices JIST 14971 2003 17 3 30
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