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資料1 医療機器の承認基準案について(PDF:2151KB)
Contents
1. Vs
2. 2 A
3. WS JIS T 14971
4. 3 16 169
5. 6 7
6. 2 JIS T 14971
7. 4
8. 2 JIST 3269 20XX JIS T 14971 2012 3 JIST3269 3
9. FE v o 1 4
10. 35
11. E 95 3 2 4
12. 5 7 0310003 17 3 10 9
13. 3 16 169 4
14. 2 JIS T 14971
15. 4 2 95 3 JIS T 14971
16. 64
17. 4 i Se
18. 16 169 2 i 15 210 3
19. 6 3 16 169 4
20. 3 10
21. 2 NS 3 4
22. 4 5 3 4 6 1 4 6 2 gt 4 7 0310003 17 3 10 9 JIS T 14971
23. 5 JIS T 14971 5 5 3 JHS_T_0993 6
24. 6 MI JST 3250 201H_T G 4 2 9
25. 7 JIS T 14971 4 2 JIS T 14971
26. JIS T 14971 54
27. 16 169 16 169 2
28. 1 3 22 2 4 E
29. 2 3 MS
30. H Y 71
31. SE 16 169 2 15 210 3
32. 2 ISO 594 1 1986 Conical fittings with a 6 Luer taper for syringes needles and certain other medical eduipment Part 1 General reduirements ISO 594 2 1998 Conical fittings with 6 Luer taper for syringes needles and certain other medical equipment Part 2 Lock fittings ISO 7886 1 1993 Sterile hypodermic syringes for single use Part 1 Syringes for manual use JIST 14971 20122003 JIS T 0993 1 20122005 1
33. JIS T 14971 90
34. JIS T 14971 MI JHST 3269 _ 0 58 5
35. JIS T 14971 0 JTS T 3250 2011
36. 2 3 H 2
37. 2 JIS T 3270 20XX JIS T 14971 2012 3 0201001 0201001 17 2 1 JIS T 3270 3 4 E JIST 3270 5 1
38. 4
39. 8 7 1 2 H
40. 3 gt 15 4
41. 5 JIS T 14971 4 2 6 JIS T 14971
42. v 08 23 3 1 5
43. S 3 12 I haemofilter 3 13 haemofiltration 6 3 14 abeling lt ke 3 15 sievi
44. 1 5 2 H 3
45. 101 1 2
46. JIS T 14971 LsS 3269 5 2 2 JHS_T 0993 JIS T 14971 LS 3269 5 2 2 JHST0993
47. 16 169 A JIS T 14971 5
48. 2 3
49. 1 50 E
50. 4 5 11
51. 5 3 Ri 16 169 4
52. 99 2 IN r C2BRIPR H v 3
53. A a NE TR TR A RR RS 0 t SN ER EE 2MEEES EERUEHEEEE UEEM EEE 1
54. 2 3
55. 14 8
56. 2 Uk 5 3 4 lt
57. a MNO 3 3 4
58. 2 JIS T 14971
59. 2 3 Nb
60. 4 2 JIS T 14971 4 3 4 4 4 5 1 4 5 2 4 5 3 4 5 4 4 5 5 4 5 6 4 6 1 4 6 2 4 6 3 lt 2 JIS T 14971
61. 98 JIS T 14971
62. 8 40 1 2
63. 3 _ 1 16 169 JIS T 14971
64. MOS 15
65. JIS T 14971 JIS T 14971 JST3250 201_ G 4 4 4 1 4 4 2_ 5 1 5 2
66. 7 1 8 1 z
67. JIS T 3250 6 1 29 2
68. 2 3
69. 4 5 8 6
70. 8 16 169 9 10
71. 2 JIS T 14971 NAS JHST 3250 201H_T G G 41
72. JIS T 14971 ST3250 20THXT G 4 4 3_ 4 4 4
73. 16 169 9 10 17
74. 5 7FF 6 9 7
75. 3 16 169 4 16 I 3S 169
76. JIS T 14971 S 3259 20 G G 4 6 JIS T 14971 OO HS 3250 201L G G
77. uj 16 169
78. oO 5 i 9 6 7
79. 2 1 7 16 0216002 17 2 16 2 85 2 5 7 16 298 1 75 2_8 3 3 O
80. E 2 1 0
81. 1 3 4 2
82. 3 H
83. yr 6 93
84. MA 3 B 3 5 4 oO 5 5 f
85. 4 oO 9 82
86. JIS T 14971 JIS T 14971 otn SO 38 2
87. 4 s 5
88. 6 H 2 6 5 4
89. S 3269 5 2 2 JHST_ 0993 5 3 JIS T 14971
90. 5 6 H lt 7 i 8
91. 74 2 JIS T 14971
92. 95 5 0 11 2
93. kN 3 R 3 15 210 MS De
94. ul a 2 3 3 62 4
95. 2 60 4
96. 5 amp 77
97. a 1 16 169 JIS T 14971 A
98. 16 169 16 169 76 2 15 210
99. 4 5 JIS T 14971 HHS3269
100. yr RE A 30
101. 16 169 JIS T 14971 NM 5 16
102. 13 2 3
103. 6 7 13
104. 0 5 6 S3269 gt A 5 2 8
105. 2 5 H 1 0 6 CX 7
106. 3 4 0 JIS T 14971 40 JHS 3250 201
107. H 2 JIS T 14971
108. 4 5 1 1 4
109. RS GMPQMS 4 4 CFP 7 3 30 0330001 17 3 30 16
110. 25 2 5 7 6 16 2 9_8 298 1 4 6 746 O O23 9 1 4 A O
111. 0310003 17 3 10 es ee 0201001 0201001 17 2 1 84 JIS T 14971 L ED
112. 2 SC ERR 3
113. 8 9 16 169
114. JIS T 14971 53 4 8 5 2 Bp 5_ L9 EURO 5 2 JIS T 14971
115. 11 2 12 JIS T 3250 G G 6 1 6 2 63 4 W 12 1 a b d e f TMP g
116. 5 JIS T 14971 JST3250 201 G 41 6 6 JIS T 14971
117. 2 5 2 1 2 5 1 1 2 1
118. JIS T 14971 JIS T 14971 JIS T 14971 JIS T 14971
119. b d c e g YYYY_MM 2 1 ES 7 jo ka
120. 16 169 JIS T 14971 5 16
121. 16 169 JIS T 14971 6 JIST 14971
122. GMPQMS 4 4 0330001 17 3 30 8 16 169 9 10
123. JIS T 14971 5 16 169 2 JIS T 14971
124. 20 2 0 3 RN
125. 5 3 CPF 7 3 10 0310003 17 E 3 10 i CE 19 4 27 5 37
126. 2 3 HAS NIR SA 1 5
127. 2 3 4 0310003 9
128. 5 1 4 2
129. JIS T 14971 P 16 169 2 F E E E
130. 16 169 2 3
131. 5_L5_ 5_1_6_ 5 7 5_1 8_ 5_1 10_ 5 1 11_ 52 7 1 NN
132. 0 19 3 10 1 E
133. A RU 2 ul 3
134. 10 JIS T 14971
135. GMP QMS 4 4 0330001 17 3 30 4 4 7 6 GMP QMS 4 4
136. 16 169 JIS T 14971 SI ST 3250 2011_ 4 6 8 6 JIS T 14971 HHS 3250 2011 RMT
137. a 1 16 169 JIS T 14971
138. 15 210 4
139. 3 67 4 2 5 68 1
140. HS IE JIS T 14971 JIS T 14971 JIS T 14971 JIS T 14971 JIS T 14971 59
141. SG 6 GMP QMS 4 4 0330001 17 3 30 4 4 7 S 3269 5 2 8
142. 5 2 6 OHI2 11 4 5_3_ OFR 4 5 4_ 4 5 5 7 12 7
143. 10 98 35 2 lt E
144. 5 1 4 2
145. 7 32 7 JIS T 14971 JST 3259 201 RS G
146. 0 4 o 5 5 a Ns 6
147. 80 4 5 a 11
148. 4 5 3 UER 4 5 4 4 5 5 JIS T 3250 JIS T 3250 4 5 3 UFR mL hr mmHgs 25 JIS T 3250 4 5 2 GN 50 50 300 500 mL min 8 JIS T 3250 4 6 9
149. JIS T 14971 JIS T 14971 JIS T 14971 JIS T 14971 79
150. JIS T 14971 H 8 gt 8 3 169
151. b JIS T 3269 1 2 3 4 STR PS 7 49 2 2
152. 2 3 10 6
153. 7 HS 3250 201_ G 42 9 GMP QMS 4 4 1 3 30 0330001 17 3 30 8
154. 0330001 17 3 30 GMP QMS 4 4 1 0 3 3 353 OM Nn 3 JIS T 3250 3 1 blood compartment 3 2 Clearance
155. 2 2 7 1 3 2 5 7 _6 16 2 9 8 298 1 711 2712 741 5 83 753 2_ 3 2 9 O
156. o 6 5 7 3
157. 0 oo 5
158. 4 Ii E JH5 3250 20H FE EMEA 9 36 GMP QMS 4 4 CF 7 3 30 0330001 17 3 30
159. MM 1 16 169 JIS T 14971
160. 15 4 ed 5
161. 0310003 17 3 10 MA SRD 4 7 JIS T 14971 16 2 1 0216002 17 2 16 104
162. 1 2 4 E 2 95 3
163. 89 nn 9 3 6 hub 3 7 tip 3 8 4 4 1 STERILE
164. 4 5 11 39 2
165. 33 2 JIS T 14971 JST3250 2011
166. 1 2 1 3 TE 4 2 5 86 1 1
167. 2 105
168. JST 3250 201_ 4 6 6 JIS T 14971 34 8
169. 0427004 19 4 27 9 JIS T 14971 JIS T 14971 JHS 3250 20H 3 4 4 2_ 5 1 5 2 JIS T 14971
170. Sa lt 97 6 H 2
171. 15 210 E 5 56
172. NO 11 E NS 100
173. 3 JIS T 3250 1 JIS T 3250 4 5 3 UFR mL hr mmHg 25 JIS T 3250 4 5 1 Bj 10 15 8 20 2 JIS T 3250 4 5 2 50
174. 5 5 3 LIS 0993 3 JIS T 14971 JIS T 14971
175. 1 Du 1 2 1 8 4 3 3 7 2 5
176. 2 3 4 9 5 I
177. 1 1 2 i JIST 3250 20XX ISO 8S637 20042010 Cardiovascular implants and grB etal ergaftSs extracorporeal systems Haemodialysers haemodiafilters haemofilters and haemoconcentrators JIS T 0993
178. 4 8 4 1 4 7 JIST14971 a A A 1 EN 1707 1997 Conical fittings with a 6 Luer taper for syringes needles and certain other medical eduipment Lock fittings ISO 10993 1 20092003 Biological
179. ul 3 4 E E EX 4 3 6
180. 1 4 83
181. 2 JIS T 14971 d H 5 5 5 3 JHS_T_0993 1 JIS T 14971 i 5 3 JHS_T_0993 JIS T 14971
182. 2 v 0 42 3
183. 6 JIS T 14971 4 3 4 4 4 5 1 4 5 2 4 5 3 4 5 4 4 5 5 4 4 4 4 5 6 6 1 6 2 6 3 94
184. 3 3 convection 3 4 dialysate dialysing gid dialysis fluid 3 5 dialysate dialysis fluid compartment 3 6 diffusion 3 7 filtrate 3 8 haemodiafilter 1 3 9 haemodiafiltration 3 10 haemodialyser i 3 11 l haemodialysis
185. 4 5 JHS F32s0 G 6 6 4 4 4 41 5 1 JIS T 3250 4 4 1 5 2 JIST 3250 4 4 2 5 3 JIS T 3250 4 4 3 OS 5 4 PP a JIS T 3250 4 4 4 5 5 JIS T 3250 4 4 5 4 6 L 4 1 7
186. 57 6
187. 10 JIS T 0993 7 TJSO_10993_7 2008 11 11 1 2 12 28 _ JIS T 3250 6 1 6 2 6 3
188. JIS T 3252 2007 JIS T 3261 20122007 3 36 0330001 17 3 30 GMP QMS 4 4 2 0 40 0301 20 24 3 1 3 3 1
189. S 49 2 ER SN I 3 10
190. is 13 nr 2 NT
191. JST 3250 2011 1 2 SN _ 2 9 GMP QMS 4 4 7 3 30 0330001 17 3 30 7 MAS
192. 4 NO NY 5 6
193. 2 5 26 1 1 t9 wn JIS T 3250 20XX JIS T 0993 7 2012 1 1
194. 0330001 17 3 30 3 8 16 169 78 9
195. JIS T 14971 4 i H
196. 169 JIS T 14971 6 JIS T 14971 3 4 51 8 HSsT 3269 5 2 IN 5 3 5 1 4
197. i 1 61 5 6 7
198. 2 6 JIS T 14971 S 3250 2011 EL 8 9 4 1 6 JIS T 14971 HS3250 201 4 4 2 5 1 5 2
199. 6 12 17 3 10 0310003 17 3 10 mk uy gt et 24 16 2 1 7 3 16 0216002 17 2 16 2
200. 7 8 21 1 2
201. 3 JIS T 3250 4 5 3 UFR mL hr mmHg 25 JIS T 3250 4 5 2 50 2 1 1 a 1
202. 8 _ 1 3 2 sheath introducer i 2 3 3 dilator 1 1 3 4 distaLemd patient end ll 3 5 effective length
203. 1 7 SO 10993 7 Bielegieal evaluation of medieal deviees Part 7 Ethylene oxide sterHizatiorn esiduats 0330001 17 3 3 30 3_9 033099 4 E GMP QMS 4 YE 0 9 _ L _ CM 2 2 0 2 1012 2
204. 5 2 2 JHST 0993 5 6 JIS T 14971 55 8
205. 9 4 8 JIS T 14971 NOY 70 2
206. 3 46 4 2 5 47 1 1
207. QD mside mner diameter Effective Usable ensth mm 1 SO 2 F Ch 1mm 3F Ch ll b Maximum Max Guidewire GW diameter c 9 e f g h 9 Tt i
208. GMP QMS 4 4 0330001 17 3 30 4 4_ 8 16 169 9 10
209. 169 JIS T 14971 JST3250 20H G 4 6 8 6 JIS T 14971 JHST 3250 2011 3 4 5 2_ FR 4 5 8 GE 31 4 5_4 4 5 5
210. 3 4 3 5
211. 3 OS gt WY 63 4 s
212. 6 3 JIS T 14971 JIS T 14971 4 SHI
213. 4 5 JIS T 3261 5 4 1 4 5 2 JIS T 3261 5 4 2 90 4 5 3 6 JIS T 3261 5 4 3 4 5 4 JIS T 3261 5 4 4 4 5 5 JIS T 3261 5 4 5 4 5 6 JIS T 3252
214. 4 6 JIS T 14971 6 HS 3250 201L G 4 4 1 5 1 5 2 13
215. YYYY_MM b i 12 2 a b c dd e f g YYYY MM h i UF 1 12 3 a
216. 4 16 169 JIS T 14971 5
217. 0 JIS T 3250 3 l 1 JHSF3250 4 4 44 14 5 1 JIS T 3250 4 4 1 2 Fr E JIS T 3250 4 4 2 3 L JIST 3250 4 4 6 L 27 6 6 JIS T 3250 4 1 7 JIST 3250 4 5 4 5 2
218. 9 0 _ 6 4 6 3 JIS T 14971 JIS T 14971
219. 4 5 JIS T 14971
220. 44 5 KS 5 3 5 4 5 3 10 0310003 17 3 10 18 9
221. 5 2 7 C 0310003 17 3 10 9
222. JIS T 14971 JIS T 14971 JIS T 14971 bs
223. 44 2 5 7 16 298 1 371 555 562 i 2
224. 12 CFP 17 3 10 i 0310003 17 E3 10 43 16 2 1 7 0216002 16 1 17 2 16 T 2
225. 4 JIS T 3269 5 1 5 2 1 5 JIS T 3269 5 2 2 6 JIS T 3269 5 2 3 7 JIST 3269 6 7 8 4 7 JIS T 14971 a 48
226. 4 2 4 2 4 8 1S 2 13_ 0213091 Eis JIS T 3261 6 4 3 JIS T 3261 5 2 4 4 JIS T 3261 5 3 CEE
227. Gintravascular catheter introducer 3 2 3 3 1 1 87 Ne 8 9 _ 5 6 b 88 c 8 O d 9 e 3 5 2 6 7 CO Io
228. 1 1 2 6 45 6 6 8 6 1 1 2
229. 17 3 10 S3269 7 JIS T 14971 16 2 16 2 2 1 0216002 17
230. 4 9 E Ei 72 0 73 7 3
231. 5 2 5 3 5 4 5 5 A 4 6 4 6 1 JIS T 3261 5 5 1 4 6 2 JIST 3261 5 5 2 4 6 3 JIS T 3261 5 5 3 4 7 a
232. 3 B 8B 8 5 5 1 5 15 1
233. H 3 1 E 4 a 5
234. H 0 8 16 169 96
235. 1 2012 1 ISO 10993 4 2002 Biological evaluation of medical devices Part 4 Selechon of tests for interactions with blood Amendment 1 2006 S JIS T 0993 7 2012 7 ISO 10993 11 2006 Biological evaluathon of medical devices Part 11 Tests for systemic toxicity ISO 594 2 1998 Conical fittings with 6 Luer taper for syringes needles and certain other medical eduipment Part 2 Lock fittings JIS T 0307 2004 0 Ss ED 2 gt a gt 0301 20 24 3 1
236. 2 EX id 7 1 1 Es
237. 2 16 2 2N 2 65 2 5 7 16 298 0 1 380 Na O j MN A RN CR
238. evaluation of medical devices Part 1 Evaluation and testing within a risk management process ISO 11070 1998 Sterile single use intravascular catheter introducers ISO 11135 1 2007 Sterilization of health care products Ethylene oxide Part 1 Requirements for development validation and routine control of a sterilization process for medical devices ISO 11137 1 2006 Sterilization of health care products Radiation Part 1 Requirements for development validation and routine control of a sterilization process for medical devices ISO 11137 2 2012 Sterilization of health care products Radiation Part 2 Establishing the sterilization dose ISO 11137 3 2006 Sterilization of health care products Radiation Part 3 Guidance on dosimetric aspects ISO 14971 2007 Medical devices Application of risk management to medical devices 92 2
239. v E 1 o H E j E JIS T 14971 10
240. 1 5 1 2 5 1 4 1 5 1 5 5 2 5 il E 5 1 3 mn JIS T 3270 5 3 6 JIS T 3270 5 4 7 JIS T 3270 5 1 6 5 1 7 6 7 8 17 2 1 0201001 0201001 E 2 E 69 a
241. 4 1 GMPQMS 4 4 0330001 17 3 30 7 NII 4 1
242. JIS T 3250 CG PE 4 5 4 5 1 4 5 2 1 OHP 737 L 1 8 JIS T 3250 3 G 0 HP 9 10 JIS T 0993 7 i i 11 11 1
243. ng coefficient 2 Me 3 16 ransmembrane pressure TMP 2 TMP l 3 17 ultrafiltration coefficient LT HA EF mL mmHg hr
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