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平成23年度 分担研究報告書 医療機関に対する医療機器の添付文書
Contents
1.
2.
3. 107 7
4. 16 1
5. 1 ME Dr
6. 6 9e 0
7. 2 A B
8. M PMDA
9. lt PMDA HP
10. 2m
11. HP MO
12. JMPN
13. 0
14. 109 1 Dr
15. 0
16. PMDA 1 1
17. 2 0
18. 4 I
19. 7 6 NS
20. 5
21. NS ME ME MM 5
22. PMDA PMDA
23. 8 99 18 20 31 30
24. 24 1 Hg 2 3
25. 2 3 4 or
26. TA BC NG CN
27. 13 1 PDE 2 3 1 PDF 2 3 PMDA PDF 1354
28. PMDA DE 1 2 1
29. UM RU No
30. PMDA
31. 3 DOCG MM
32. 8 8 A 8 9 A 9 10J A 10 L11 A 11
33. 5 122 33 5 089 1 530 20106 Q 1 LA 0 6 I 1 TT TS ET TT w 50 51 100 101 200 201 300 301 400 401 500 501 600 601 700 701 800 801 900 901 1 000 1 000
34. 524 34 0 486 31 0 266 17 0 0 7 1 040 69 0 3 8 7
35. HP CD
36. MNO WM
37. 44 100
38. 4 le 105
39. G 2 H a ET
40. 2 MC 1 2
41. 17 24
42. PDF PMDA 9 D 40 30 29
43. PMDA PMDA
44. 23 1 1 1 2 100 5 122 2 Q 2
45. L15 PDF
46. 29 17 24 WG
47. PMDA 0 CD ROM USB 0
48. 1 249 60 203 81 6 150 60 2 142 57 0 141 56 9 101 40 6 85 84 1 2 6 15 5 5 83 3 3 50 0 2 33 3 2 83 3 3 82 18
49. 108 2 ON 0 HP 1 2 PL 3 PDF 2
50. A
51. _ II 4 3 89 5 4 59 5 5 6 48 3 760 53 7 2 654 45 a 100 6 6 7 139 9 PP mh 893 53 507 30 0 5 0 2 no 8 5 3 No i 2
52. mm lt KAX W gt gt XK ue 2 X ta gt SA m T NESE IT 4 1 2 3 4 6 7 3 700 453 12 2 193 59 962 26 92 3 299 G
53. 3 DVD
54. 0 OK 70 106 6 14
55. 1 PMDA
56. PMDA
57. SN EDG PMDA 5
58. 906 1 530 59 2 822 53 7 PMDA L10 1 2 RTC 3 2R4
59. ES ES PL 2 en
60. 114 2 2 3 702 40 249 299
61. Y Y YY 2 AN 14 Y lt X 1 4 4 7 7 ph co cc 9 9 9 go c Ob OT OT OT CC rT 3l ZL p J 4 75 gt 47 N GR lt IF a TH HH EE 5 C HE TD a gt 8 1 1 1E HH tk 3 a se HN HOE HH a S Im 3 1 hs SS EE Sr TT
62. SM PDF PC ME PMDA
63. 1 2 3 4 5 6 7 1 2 93 4 5 6 7 1 2 3 4 5 6 7 1 012 917 789 601 7
64. 24 24 ik 18 h h 2 2100 3 049 2 600 3 000 3500 2700 RS Se PC 4 1 000 60
65. 30 1 30 19 100 400 74 34 31 69 69
66. NS 5 1 1 etc
67. PMDA
68. 24 Q 30 1 100 400 749 53 309 34 31 69 3 702 40
69. I 1 2 EC 5 6 1 2 3 4 5 6 7 8 3 702 1 486 409 882 24 608 17 348 9 249 7 82 29 41 1 6 14 6 8 3 2 1 1 6 2 1 2 3 4 5 6 7 8 3 702
70. CC oO A4 TT Ao
71. 3 239 1 853 3 609 519 1 533 439 75 323 56 582 1 460
72. mm I SE PS 4 jn Nf 57 1 lt 7 lt TT 1 se hn Xx ya lt 6 LE i sx4e4 1 ve X c 9 s V ze ck i i Er X 4 8 0 d X S S 9 d X W
73. 6 7 85 71 69 63 5 2 5 8 9 4 247 6 2 3 1 2 3 4 82 1 481 887 347 2 4 2 4 1 2
74. SEE VN EE CE EE CE EE NN A PH HE RNN NE 0 ii ii ti T RE III EE 4 2 2 2 2 Si 5 5 5 5 5 1 93 33 33 32 31 29 29 wm lt 2 1 hp JI 338 NIS NN 1 1 HN EI HHH T LO RY U 4 Se fr 6dr0 PK Ware NO Trrs CO C O CO CO CO CO NON GNGN GN O 10 OWO ZOAS ZOgS
75. 8 1 2 3 4 5 9 1 2 L10 2 1 2 3 L11 1 2 3 8 9 10 MESME1M 3 391 351 5 598 136 277 100 6
76. 2
77. 1 040 8 IV 9 1 2 3 9e 5 6 PMDA PMDA OT OE
78. WG CT UNO 0 E 69 3 552 179
79. gt E ds 100 WPG 5 MM kc kk SN ETE tof EE 4 Ka EE EE ERERN 115A5A 416 450 9 20 1716119 8 8 7 6 6 5 4 4 444333333 3 44 41 RK AK H gt UIE KK iN 1 0 NSIMW ME AA AN DN
80. 884 41 13 12 2 80 73 70 5 62 60 0 46 40 20 10 0 T T T T T T T mm mm 2 Sm 1 yy gt 5 9 a 1 a
81. A a L14 1 2 3 4 5 6 7 8 S01 9 dd 0U2 3 302 1 2 14 3 302 H5 449 149 2 853 86 104 L15 14 1
82. 1 1 2 3 1 175 87 L12 11 1 1 2
83. 25 30 5 16 19 5 14 17 1 7 8 5 4 1 486 107 1 815 88 5 1285 83 1 1 143 76 9 793 53 83 714 48 0 616 41 5 489 32 9 207 183 9 5 882 93 793 89 9 774
84. MRI PS AN TA KK NG MI PS RR KK 11 KK x XK GW 1 AN 15 LTLLI IL 9 Pr x ME NR hit 0 0 AIK Mi 4 A 18 No T
85. US 5 6 ES 2 e 2 e e e 3 4 5 6 2 8 9 1 1 s 11 8 9 10 11 12 13 2 1 2 3 4 5 6 1 2 3 4 5 6 7 8 4 9 2 10 11 8 9 10
86. 1 562 9 5 1 549 9 5 1 2 3 4 5 6 7 8 Y MN 16 362 3 6
87. PMDA 2 X CT MR
88. 4
89. R R Id NINN Q gt gt 1 8 KOE SE DH NH 28KIIB Nuk Am m NAN SN gt H 1 KK gt HH MG co IS Q KK R R 1 N gt K 0 KNR TINN hE IJ 24443333222222222 2 RA eS Py Mm EE NE
90. gt 1 gt 11 12 13 RS RS oO TD 1 CO Lo CO OO DO To co ES Co ew Re CD gt 5 Oo co 1 mm mm lm lm ea EE 4 ES 5 147 6 383 188 ommag ie EC jm 2 903 236 144 4 153 5 218 6 wawew waoWomm wl ws 8 9 8 98 103 10 1 634 135 141 10 1 028 240 181 13 Re as mks ee awaeaaee el ass mm mea ml al s 8 RA 9 ml G
91. ml ae nu 9 394 wl F 56 el nu 0 E MK m lt 1 4 104 5 4 0 sg 246 19 6 8 9 TT ET ET ET 8 86 15 3 4 6 1 3 4 5 6 7 8 9 10 11 9 10 12 13 FE EE EE OO 1
92. 5 7
93. 919 529 1 549 386 2 523 350 4 387 284 es sm 6 980 9195 305 7 693 240 246 8 99 2 666 233 290 11 446 9 170 9 311 347 10 566 453 11 831 743 12 193 62 2 285 13 148 46 1o6 424 Ss 4 13 9 3 0 5 9 6 64 9 ml a eo EA 126 GE al 2 2 OU 2 ri 6 60 20 sz 8 GO s 9 8 0 9 sl 17 52 13 3 4
94. 1 530 88 4 ee 14 0 i 3 2 MM 43 5 CO mm R CoO LC 1 211 5 438
95. 24 B 100 5 122 Q 2 Cg C 1
96. PMDA NN AO
97. 0 1 0 9 1 5 6 10 11 15 16 20 21 25 26 30 31 246 6 0 1 0 9 1 0 9 1 5 1 5 6 10 5 10 11 15 11 15 16 20 16 20 21 25 21 25 26 30 26 0 31 31 1 1 21 82 608 4 _0 _4 1 0 9 5 5 10 11 15 0 1 0 9 1 5 6 10 11 15 16 20 21 25 26 30 31 16 20 21 25 26 80 31 1 486 41 0 1 0 9 0 1 0 9 5 1 5 6 10 6 10 11 15 11 15 m16 20 m16 20 21 25 21 25
98. e 1 mm ET me CT gt 0 ee K x om EE gt 00 1 ls RK mn HK Mi SM ee ee ha eT ma Oe PU En es AK 4 ii 2 N ha AT 00 Ne 30 425 20 15 10 0 3 CN CI CI CI CI CI 7 A PET T ME ECMO ECT TI R aa
99. ls 3 552 234 6 21 74 579 38 1 424 870 7 4 4 1 ME NS 327
100. 1 530 101 200 633 41 201 200 307 20 301 400 194 18 74 66 4 2 1 DI a 7 696 2 21 5 2 1 4 4 1 1 530 744 A 49 5 324 21 5 3 RR 809 Ps 80 3 809 14 3 11 2 15 2 1 494 100 ER 80 897 60 _ 5
101. 26 80 26 80 31 31 1 31 882 3 _ 2 1 11 31 0 1 0 9 5 16 31 6 10 1 1 5 16 1 15 31 21 31 26 30 5 81 348 3 0 0 1 0 9 1 5 6 10 11 15 16 20 21 25 26 30 1 3
102. 5 60 190 550 PC RCR 6 UPCC PDF OU PC PDE 2 lk 9 5
103. 2 1 2 A4 2 PDF
104. 87 8 666 75 5 653 74 09 585 66 3 360 40 8 233 26 4 ra 6 348 57 285 81 9 253 72 77 202 58 0 147 42 2 188 39 7 7 608 57 C 486 79 9 X 367 60 4 MR I 316 51 9 X 311 51 1 149 24 5 X 185 22 2 110 118 1 8
105. sg gt h HH A ACTH NNSA1 8 pn Te G GU EGG i 1 HOH ud 00 Mm Ma Ei al 1 8 8 5 A 6 BF RP 30 be 5 0 AN 2 31 29 1111 3 222221111111 1 eee 70 10 O 9 RK gt KAN X gt lt X R R 1 rk ta DP ee a 1 4 EE EE EE mm mig
106. EE RE 4 i 5 a 6 6 7 8 sy Co D 9 11 12 13 sw ew 1 gt 12 1 2 3 4 5 6 7 8 lrl218 4 5lel7lmlIS 1 2 1 3609 1 2
107. L 6 90 2 5 611 Lo 234 49 20 9 3 552 6 2 33 3 74 171 4 8 10 13 5 1 424 447 2 6 2 823 247 7 8 870 65 472 521 14 7 192 22 1 327 33 10 1 579 20 73 12 6 38 5 13 2 1 2 3 4 5 6 7 8 peW
108. X W X G G G 6 OL OL TL tr tr SL 8T OZ TZ gz gz SE Or HH Lcer 43 90 ES TTE 9TE W EE 38Y SnAD 1 34 4 Y T CG BT ZX 6 CCGCA1IZ n Y Y Y OQ 5 rr 4 oO N es mc NENEE IC sx 4m 10 10 1 3 3 15 10 SN ES K
109. 1 1 2 3 4 607 1 2 5 1 43 2 9 4 L5 4 1 2 3 16 362 3 092 18 9 2 378 14 5 2 215 18 5 1 746 10 7 1 601 9 8
110. 41 41 10 24 4 10 24 4 9 22 0 8 19 5 7 17 0 60 qT wu a Nm TS X K OF AN AN AN AN AN AN CN CN AN AN AN AN Mm Ne IAA 00 00 le AN Mm 00 77 CT C
111. CO 1 2oo 99 4 PMDA 474 RCE 5 PMDA 1 2 3 4 PMDA 5 PMDA 6 1 255 1 530 82 09 PMDA 1 4 L11 1 letb 120 2 leo pm
112. E II PO An Rll bt EE IE je LF LU 1 107 gt x TT R K RE s ji K K PE RR Rd KK ERIKIE 3 63 61 53 52 44 42 36 11 111 1 06 103 101 1DO 95 95 1 1 S 3 NS MR mm NT Mnr A AN Q RE ES RSS kil S 8 8 8 2 O
113. Y EE HD kam TE HE EE BEI Ws I es HN HE Ft RE Js gt amp EE tl 6 6 Hm HE al OOGNQGNQGNGNGNGNGNGNQGNNNGNN s LU IN 1 8 NS LN NA 0 6 la NG ESN ED EE a EE mW lt o Fl Fm ss Fm oo LO s nm ME eh a mm 1 wm
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