医療機器安全管理指針 Ⅱ
Contents
1.2.
3.
4. WEB
5. Go 12
6. AED 1 123
7. 100
8. AC
9. 2
10. 2 1 35 145 63 2 1
11. PMDA 2 1
12. 5 ICU
13. 3
14. 3 4 5
15. 4 9 ke EE Japan Association for Clinical Engineers er g CE 5
16. 3
17. DVD 5 6
18. CO 4 1
19. G L Ver 1 00 3 4 LCD liquid crystal display
20. 2 3 4
21. 0 2 3 48
22. AED AED 8 3 bo CD
23. 3 ur EE Japan Association for Clinical Engineers 4
24. 36 8 1 7 10 9 9 1
25. 3 ee Japan Association for Clinical Engineers 4
26. B A
27. 2 6 ICU Intensive Care Unit 7 7
28. ICU AC
29. 10 18 2 5 10
30. 3 IS Japanese Industrial Standards 1 7 ee Japan Association for Clinical Engineers 1 1I ME ME
31. 2 1 2 1
32. TL 1 41 fe EE Japan Association for Clinical Engineers ac 5
33. 4 7 1
34. 2 5 2 1 2 3 tl1020 Mii22220 4
35. mL h 2
36. 2 AED
37. 5 6 66 H 7
38. 2 AED Automated External Defibrillator AED 2
39. 20 60 1 3 45 6 7
40. 3 2013 7 1 4
41. 2 4 5 2 6
42. 6 68 22 3 4 7 68 21 8
43. A OB xx xx 5 1 2 26 10 2 1002 5 6 1 2 7 1
44. 5 46 lt 2 MS 7
45. A4 A 4 1 5 Q7 8 1 2 3 2 1 3
46. 3 12 3 1
47. 1 Ver 1 00 2012 9 2 1 2013 7 3 4 AED 1 2 1 1
48. 3 4 80 120mmHg 5 7
49. 2
50. 10 1 2013 7 10 1 30cm 2 5 40C 30 90 0 07 0 106MPa 10 11 1 2
51. LN CD 1 3 1 Oo CO to 4
52. 5 63 2 2 26 9 1 0901 4 4 11 25 1 103 EE Japan Association for Clinical Engineers
53. 5 2 5 3 90C ON OFF
54. OOOO Xxmg OOmg mg 6 1002 5 26 10 2 26 10 2 1002 8 1002 1
55. 9 6 a fe EE Japan Association for Clinical Engineers 0 1 2 1 1 2 1 00
56. 8 EN 6 1
57. 2 1 SpO 2 2 1 1 SpO 2 3 2 2
58. 1 RI 1rnI Veb 1m meh OFF a 5 fe EE Japan Association for Clinical Engineers 4 1002 8 26 10 2 1 17 3
59. 2 A B C D E
60. 4 5 6 7
61. 2 3 gt
62. 5 6 4 7 8 4 4 1
63. EE Japan Association for Clinical Engineers 1 A BF 3 2 4 1 Re 1 2 2 5 AED 1
64. 4 4 1 1 AED 2 3GP
65. 5 5 7 9 2 16 298 6 9 Q 7 5
66. 2 ER 2 2
67. 3 OFF OFF OFF 6 1 2
68. mm Q amp A 24 10 26 1 13 14 1 248 13 3 27 SpO http www konicaminolta jp instruments knowl edge pulseoximeters information pdf SpOs pdf 2014 6 30 Q amp A 2014 3 wwwjrs orjp uploads uploads pulse oximeter_medicalpdf 2014 6 30
69. 2 1 2 3 3 3 1 2 3 3 2 1
70. 2 3 4
71. 4 E Japan Association for Clinical Engineers Ry 3 4 6 3 1 2
72. 5 1 2 AC AC 3 AC 4 5
73. 6 7 1 2 3
74. 9 J
75. 3 1 2 29 fe EE Japan Association for Clinical Engineers ac 3 4 HME heat and moisture exchanger 5 1 6 4
76. 5 6 7 FN 30 4 2 4 2 1 1
77. 2 3 ug kg mm mg kg h 1 ee Japan Association for Clinical Engineers 5 5 1 1 AC
78. 10 1 2013 7 10 10 11 1 GN ih ea 2 3 i fri eo ie 4 5 1
79. 1 10 0 10 92 9 1 ON 2 2 2 2
80. 660nm CPR 8 BE 5 6 1
81. 2 CPR Cardio in Resuscitation 2 6 3 3 1 1 2 3 MRI 3 2 ss 2
82. 2007 4 1 Ver 1 02 2007 5 6 1 2013 7
83. G SpO2 7 1 2 3
84. 1 ECMO CC membrane oxygenation PCPS Percu taneous Cardio Pulmonary Support Reit ho WN 2 1 O
85. C 7 7 1 JMDN 35004000 JMDN 35005000 JMDN 70536000 JMDN 70529000 7 2 gt JJMDN 34999102 7 3 JMDN 13929001 6 1
86. 3P 2P 3P 3P 2 I ME I ME 2P IL ME 3 ME ME ME 1 ME
87. 3 3 3 4 4 4 1 5
88. 7 1 2 2
89. 2 5 1 3 7
90. 5 G6 7 4 1 2
91. 120 4
92. 2 3 4
93. 3 1 MRI 2 4 1
94. 35 145 36 1 1 1 2 2 1
95. 1 6 1 7 1
96. pH potential hydrogen 2 3 pH
97. 17 4 1 FAX 4 1
98. 1 8 p111 123 2014 2 37 3 2 p145 150 2014 3 1 p82 87 2013 TE 331S SP 80S TOP 5520 SP 505 1235 Co OO Q 85 1
99. 2014 10 I 1 2007 4
100. LCD No to i ESD electro static discharge
101. B BF B BF 4 1 gt gt 2 1
102. gt 1 2 3 5 AC DC 6
103. GO MRI tz 1
104. 2 110 2 1 2 3 1
105. 2 7 2 8 LED y 40 40 1 mmm 1 OHDb 8 Hb 2 5 2 6 4 4 40 2 SPOs EE Me AMMM lt _ OOHb 100 SPO2 OHb Hb 2 7 2
106. 25 1 1 2013 7
107. 3 4 62 5 6 7 OFF
108. 0427004 kd UM A B C 20 A B C
109. DC AC EE Japan Association for Clinical Engineers 4 2 2
110. 1 2 3 4 5 6 7 8 9 10 A 1l AC 12 1 2 3 4 5 5 6 7 8 1 2 AA 3
111. il 4 E 204 E 2 E
112. 0330001 AED 20 3 35 145 2 4
113. 4 5 4 4 1 4 2 4 3 7 1
114. S ke EE Japan Association for Clinical Engineers 2 4 5 1
115. A B C A PI Peripherally in serted CV Central vein B A
116. 3 10 1 10 40C 30 85 96 2 3 70 106kPa 10 70C 10 85 RH 700 1060hPa
117. 2 1 2
118. PEEP positive end expiratory pressure r sr PEEP 28 2 1 2 3 foamiE EET EL
119. 90 2 1 2 2 2 3 2 4 2 5
120. 2013 7 1 http wwwja ces orjp ce wp content uploads 2013 03 089a9b030c6a90b3045f15891 d2d9fcepdf 8 7 10 1 1 1
121. 2 2 1 TV
122. 1 TEC 5500 2012 2 AED 2100 2012 3 1 2013 fe EE Japan Association for Clinical Engineers 5 1 2 1 2 1
123. 23 QO 1 1 2 3 4 5 6 7 8 9 10 1 12 13 14 15 16 17 2 1
124. 2 AED 5 5 1 1 A B C
125. 4 G5 6 2 1 1 2
126. ac EE Japan Association for Clinical Engineers lt COHb MetHb
127. 20 GQ3 114 1 1 1
128. B C Fe D E ON OFF 20 OFF OFF F G H I 1
129. 2 3 OFF 6 1 IABP IABP A B
130. 9 1 fe EE Japan Association for Clinical Engineers 30 1
131. 1 2 106 G3 4
132. 2 3 2 3 1
133. 5 7 1m 6 8 9 ZE 10 1 m 5 IEC 60601 1 2 JIS T 0601 1 2 IEC 60601 1 2 2001 2 2004 E 2 1 2007 3 JIS T 0601 1 2 2012 2 TEC 60601 1 2 1993 1 JIS T 0601 1 2 2002 1
134. 5 2 AED 1 2
135. 8 10 6 3 1 AC 2 CD 33 ur EE Japan Association for Clinical Engineers
136. 2 3 My 0 1 2 3
137. 40C ur EE Japan Association for Clinical Engineers 0 5 oo MRI 6 7 1
138. a x Ne 3 RY 0 9 GQ Nal RY Oo 68 6 1 CO tt
139. 7 7 1 2 2003 7 8 1 2 AC 8 6 10 9
140. E 17 3 10 0310004 26 11 25 IA sr Ce Japan Association for Clinical Engineers 1 1 25 84 35 145 63 2 1 1
141. 2 OFF CD 4 O 5 6 8 NIV Noninvasive ventilation 1 NIV 2 NIV NIV
142. PC
143. 1 2013 7 10 ee 1 10 40C 30 75 3000m 2 10 60C 5 85 3000m 10 11 1 SpO 2 ETCO
144. 3 ECG 1 2013 7 1 2 2012 10 3 2008 2 4 http wwwanihonkohden cojp iryo documents HAMILTON C 2013 5 6 39 1 5 EE Japan Association for Clinical Engineers ac 3 1 HD Hemodialysis
145. EMC 11 EMC EMC EMC 4 7 11 Electro Magnetic Compatibility 2
146. 1 2
147. 13 14 6 2 1 2 gt Oo 3 4 6 1 7
148. 6 1 2 NN eR 3
149. 2 3 AED 10 1 2013 7 10 1 0 45 30 95 70 106kPa 2 20 70C 10 95 50 106kPa 10
150. 4 5 8 1 9
151. PHS 2 OFF 4 CD 4 89
152. 4 i 5 6 7 i 8 9
153. a NC 5 fe EE Japan Association for Clinical Engineers 8 1 2 9 2
154. 10 1 ET 12 PEEP 13 1 33cmHzO 6 7 1
155. AED 6 AED 6 1 1 3P 2 CM Ne it 3 AC 6 2 1
156. 5 6 9 1 2 ET CD SN ee Japan Association for Clinical Engineers 3 ET 6 10 6 11 Y Y
157. 14 10 9 1 A OFF B 86 1 I a eg MO 10 10 id ti 1
158. 4 GO 1 5 QO 6 68 22 3 4
159. 3 2 1 2 4 1 2 5
160. H 7 1 8 7 10 9 10 1 2013 7
161. G6 5 fe EE Japan Association for Clinical Engineers 7 4
162. 5 1 A 70 300kPa 0 7 3 0bar B 10 30C 2 2 1 2 2
163. B A B C D E 4 A B C
164. H v G4 H 4 2 5
165. 2 3 4 2 2 PEEP PEEP cmHzO PEEP 4 2 3 A C Assist Control SPONT
166. ESD 3 1 3 2 B 3 3 3 4
167. 2 E Japan Association for Clinical Engineers 3 1 2
168. 3 16 298 JMDN i i 4 5
169. EN JIS T 0601 1 2 2012 6 3 99 E ee Japan Association for Clinical Engineers 7 8
170. 2 MRI CD 1 23 wo ES Japan Association for Clinical Engineers 4 1 1 CF 2 AC100V 10V 50 60Hz 1 Hz 3
171. 3 UI 1 E 7 93 10 2013 ur EE Japan Association for Clinical Engineers 10 1 10 40C 30 75 RH 700 1060hPa 2 10 70C 10 85 RH 700 1060hPa 10 DD NE ER APD
172. 2 LED PD Photodiode SpOz PR r 2 1 2 2 2 SpO Lambert Beer A
173. SIGH 5 5 3 1 2 3
174. 3 2 8 1 2 2 3
175. 4 6 6 1 1 2 es eo Rte io hit CD 32 5
176. RS 60 4 1 Ss gt 1 sy EE X 9 2 AC100V 50 60Hz 3 1 BF B 4 A 934 38C B 23 39C
177. 1 64 2 1 1 p70 75 2013 2 i 2013 3 GE 2010 4 8000 fe EE Japan Association for Clinical Engineers 6 1
178. 1 2 3 CO a fe EE Japan Association for Clinical Engineers Jal 3 1
179. 13 ur EE Japan Association for Clinical Engineers 6 NNN A 7 oi
180. 2 2 3 0 4 6 5 ee
181. 6 2 1 SpO CPR CardioPulmonary Resuscitation IABP intra aortic balloon pumping 2 2 SpO 84 A B C ICOHb
182. 4 5 6 3 1 NUM RN 3 hte
183. 14 1 0 O1 oO DW 6 7 9 10 11 OO 3
184. 6 4 HME 1 HME 2 6 5 2 6 6 1 CMV SIMV CD 2
185. D A B C D A B C D 2 A
186. 9 2 1 EOG ethylene oxide gas 2 9 3 Ry CD 1 gt pm ac Japan Association for Clinical Engineers 1 2
187. http wwwr info pmda gojp 1 0310003 17 3 10 2 4 22 11 16 3 26 3 23 25 So 16 1 1 PCPS 1 ee
188. A A AC100V ee EE ac EE Japan Association for Clinical Engineers 11 2014 10 2
189. 2 1 2 2 1 2 2 1 2
190. 2 JMDN 3 4 1 2
191. 2 63 2 1 3 4 5 2 6 2 1 4 1 5
192. 33 gt OO NOU Rw MW OO ST Oy OT SC9 RS CO GW CO 65 oO RS TO RS bg 6 OS 6 SS OS
193. 40 1 2 3 4 2 3 1
194. 2 3 8 7 10 9
195. 9 10 2 2 1 2 2 3 11
196. 3 ON 4 ON 5 OFF 6 34 ET Endotracheal tube 8 ON OFF 9
197. 6 12 1 2 OFF ON 3 6 13 1 2
198. C 2 MRI 3 4
199. 1 4 8
200. 83 ee Japan Association for Clinical Engineers 3 4 5
201. 5 4 ON OFF 5 1 ON SpDOz 2
202. A 4 1 7cm 2 A4 109 1 Japan Association for Clinical Engineers 1 1 A4 A4 eS A4 SE 2 1 A4
203. ee 0 we
204. 2 O OOOO xxmg Omg mg Jal EE Japan Association for Clinical Engineers
205. ECUM extracorporeal ultrafiltration method 49 ur EE Japan Association for Clinical Engineers 3 5 UFR en 3 6 3 7 3 8 TO
206. Lambert B Beer 98 SaO 75 HbO Hb 2 4 2 2 2 SpO2
207. 2 1 2 1 2 3 4 5 6 3
208. AC DC
209. 2 2 63 ee Japan Association for Clinical Engineers Q SpO2
210. 6 22 1 2 IABP 1 IABP intra aortic balloon pumping 2 1 1 2
211. 1 1 p73 75 2013 2 495 1972 3 2012 4 ST5 2012 94 10 AED 11 8 10
212. AC100V 3 4 31 ur EE Japan Association for Clinical Engineers 5
213. 3 1 2 3 MRI 4
214. 2 3 SpOz 4 3 1 2 3
215. 2 7 2 8 3 3 1 OFF 46 3 2
216. 6 1 2 3
217. DJ ee Japan Association for Clinical Engineers 2 3 HD HDF HF HDF HF
218. 2 1
219. 3 1 HD HDF 5 MRI 6
220. L U 4 1 4 2 1 3 1 4 OFF OFF 6 6 1 1
221. 19 ee Japan Association for Clinical Engineers 5 1 OFF ON ON ON ON 2 ON
222. 4 1 yo NA GD gt NS x 8 1 2 3
223. IPPV Intermittent positive pressure ventilation SIMV Synchronized intermittent positive pressure ventilation PSV Pressure support ventilation CPAP Continuous positive airway pressure BIPAP Biphasic positive alrway pressure 1 2 1 1 3 1 4 1 5 OO CO to
224. 11 1 2 3 4 5 6
225. 7 CD 4 HT HDF HF 1 10
226. 7 7 1 1 69 ke EE Japan Association for Clinical Engineers 2 NR i 7 2 1 2 DR 7 3 1
227. 6 1 0 2
228. 190 3 1 2 11 4 3 Leleaeroert Fi ET Laman oontet i FLI T CC ImLHIELHIT Tn 1 k 1 5 RI Lt lll LFh He Hr bi SE LE TE LE ET OEE el MNT TH
229. 2 1 3 8 6 8 10 9 10 1 20134 39 10 0 50C 30 75 70 106kPa 10 11
230. 1 1 http www gelifesciences co jp technologies ee Japan Association for Clinical Engineers spectro spectclub theo_01 html 2014 6 30 7 4 1 P 137 2012 12 8 17 3 9 88 9 1
231. 2 ee es 1 7 1 2 mL h h 7 5 1 2 7 6 1 2
232. 1 1 2 3 CR 4 et dma hen 5 6 2 1 2 3
233. MetHb B C D E 3 3 1 MRI MRI 3 2
234. O OO 2 RB
235. 7 1 2 1 2 3 4 5 6 7 8 9 10 1 12 13 4 15 16 17 105 ur EE Japan Association for Clinical Engineers 3 1 2
236. p9 20 2001 2 2001 3 1 p82 87 2013 4 2011 5 TE 161S 2012 6 FP N11 2014 7 MS 0T 888 2013 fe EE Japan Association for Clinical Engineers 7 1
237. 10 10 11 1 2 1 2 3 3 4 1 5 2010
238. 2014 10 CE Yact IT IT 1 2 ririoo ee SA W eneniieeyuss pT 5 1 II
239. 1 6 3 1 1 2 3 MRI 4 ee Japan Association for Clinical Engineers 4 1 2 1 2 2 SpO ECG
240. 6 7 2 1 2 1 2 3 4 5 4 5 1 2 8 6 1 2 7 8 9 40
241. I 1
242. 6 ON 3 OFF
243. 20 A B C D 2 5 fe EE Japan Association for Clinical Engineers E F ON G
244. 300mm 470mm 1300mm 440mm 470mm 1325mm 55kg 75kg 42 2 AC100V 50 60Hz 15kVA A B B BF C IP International Protection X1 D 3 TIL me oo i
245. AC DC 12V lt 2 3 4 5 8 2 1
246. ICU 8 6 10 ke EE Japan Association for Clinical Engineers 9 10 1 2013 E 7 by 10 10 11
247. 44 4 3 3 Pre Qs 60mL mim Post Qp 440mL mi 1 1 Qr 60mL nlin 1 1 1 1 1 1 Qpo 500mL min 3 HDF HF
248. A B CPU C 18 4
249. A B CPU C 4 5 1 OFF ON 24
250. 15 210 2 1 2 CO
251. 2 10 11 1 ICU NICU 2
252. HF Hemofiltration HDF Hemodiafiltration HD 2 1 HD HDF HF 2 1 2
253. LCD 5 40 6 7 8
254. ke EE Japan Association for Clinical Engineers 1 1 CF BF 2 AC100V 10V 50 60Hz 1 Hz 3
255. 80 T 1 T x 100 A Logio 1 1 my I 600 700 800 900mm 2 3 2 4 HbO Hb 6 4 2 LED ON OFF OFF ON OFF OFF 3 1 2 5 2 6 40
256. 2 1 2 2 1 3P AED 2 2 3 1 2
257. B C ee Japan Association for Clinical Engineers HDF HF A B
258. II ME 2 1 B BF 1 2 BF B 3 CF CF
259. ke EE Japan Association for Clinical Engineers 5 1 1 OO OO 2 1
260. we EE Japan Association for Clinical Engineers 1 AC100V 50 60Hz 15A 2 5 1 2
261. 2 8 SPO 4 8 5 fe EE Japan Association for Clinical Engineers 1 1 1 AC A AC B C 1 2 4 1 7D 7 0
262. 2 15kg 8 10 9 1 AED
263. 4 1 ON A B SpO 4 2 4 1 6 82
264. Q 8 7 Q 3 a 9 40
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266. 1 3 4 5 6 7 8 9 10 1 12 13 14 80 15 16 17 19 19 20
267. AED 3 ke EE Japan Association for Clinical Engineers 4 AED 5 4 2 AED 1
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269. 2 3 4 5
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271. 6 7 4 E 8 i 9 40
272. JIS T 0601 1 2 2012 250mW 1 15m 0dB 2dB 0 92m 18cm 1m JIS T 0601 1 2 2002 1 JIS
273. 2010 3 er EE Japan Association for Clinical Engineers 2 2 1 1 1 oo OO CO DM CMV Continuous mandatory Ventilation
274. 4 5 1 1 4 _ es 1 5000 6 AC 38 10
275. 107 ac fe EE Japan Association for Clinical Engineers 1002 1 26 10 2 26 10 2 1002 8 5 26 11 25 17 3 10 0310001 108
276. 98 IV a 1 26 8 19
277. 1 1 2 3 4 2 3 4 8 G5
278. 10 0310003 25 84 26 78 11 25
279. 2 3 8 _ 7 10 9 10 1 2013 7 10 10 11 ee TO 26 1 V IABP 2
280. 6 495 1972 1 2 3
281. AED AED 3 AED AED 7 1
282. 30 0 42 0C 0 3C 20 0 42 0C 0 3C 40 95 Rh 15 99 Rh 10 Rh 30 0 42 0C SpO gt 1 100 3 21 65 5 5 1 6 fe EE Japan Association for Clinical Engineers Jal
283. LT LT 4 4 1 4 IPX 1 EMC Electro Magnetic Compatibility JIS T 0601 1 2 2012 1 LCD 4 43 ke EE Japan Association for Clinical Engineers 3
284. spontaneous respiration SIMV 1 SPONT CPAP PS Pressure Support 2 PS PS PS PS PS 5 5 1 1 2
285. 2014 10 2014 10 113 0033 3 4 3 884 4F 03 5805 2515 FAX 03 5805 2516 151 0051 5
286. 8 9 G0 a tne oo 1 ee
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