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動物用医療機器製造販売承認申請のための モックアップ

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Contents

1.
2. 1 2 1 1 13 2
3. 8 3 2
4. 12 3 31 12 A 418 2 1 2 1 1 2 ABS
5. 39 17
6. 1 2 1 5 14 6 1 2 1 6
7. 3 1 3 8 BBBBBB CCCCCC 5 720 10 J 1SZ4751 2 54 203 6 4 3 104 3 15 5 20 JISZ4751 2 54 203 6 4 4 104 4 3 10 0 2mAs JISZ4751 2 54 203 6 4 4 104 5 4 10 0 2mAs JISZ24751 2 54 203 6 4 4 104 6 5 X
8. 1 1 2 1 2 1 7 63 2 1 2 1 7 7 OO OO OQO 1 2 1 7 FAX E mail 1 2 1 7
9. X 5 X OO 3 X 4 5 X 20 MO 2 X RZ X 1 EE A N X OO 200 OO 30 AAA _ AOAOAeAOA _ 29 3 1 4 3
10. ABS 1 2 1 2 3 1 2 1 3 4 1 2 1 4 5
11. 1 X 4A 2 5 13 1 1 2 OOOO OO O
12. 17 31 2 a 54 6 2
13. SI SI i
14. 26 1 1 1 X X 2 X ei X OOOkg 28 2 1 ABS
15. 1 7 4 1 200 V 2 50 60 Hz 3 50 kVA 4 1 5 B O 23
16. 42 1 a
17. 1 2 1 2 EC 3 1 2 1 3 4 1 2 1 4 5
18. 1 1 2 gt 3 2 1 X X 2 X XX X 3 3 1 2 3 4 4 1
19. JIS TO601 1
20. 1 6 2 CC UL
21. 1 2 1 5 6 1 2 1 6
22. 2 3 1 2 3 X 4 2 1 2
23. 1 2 OOOO OO OO 23 2 17 1 1 OOOO O OOOO Company OO 10
24. 12 1 a a SI SI
25. 3 5 5 5 45 lt gt 5 5 2
26. 0 0 5 7 8 9 9 0 04 0 08 10 10 KK i JISZ4751 2 54 203 6 3 2 101 X 6 X X X mGy mA 7 7 JISZ4751 2 54 203 6 3 2 102 a X 0 6 xx yy JIS Z 4751 2 28 201 7 9 3 101 JIS 1 2 xx Z 4120
27. 12 3 81 12 A 729 2 16 107 91 25 91 23 2
28. 5 91 23 91 25 1 2 5 ST ui 2 5 a 6
29. 6 8 9 DOGE 10 MT 1 2 4 5 X X X 8 MM 8 12 50 X 1 X 2 A OO OO OOOOOOO OOO 200 NAA X AA AO XX 300 X B OOOOOOOOOOO HHHHHHHH XX JIRAD 17 X 1 X 2
30. XX 25 26 2 2 1 5 10
31. X 20 5 1 5 OO GB RO1 6 2 2 2 1 X 2 X 1 X 2 X 2 A X 300 OO 2 X
32. NN 6 X 40 150kV 50 630mA 0 003 5 0s 0 5 500mAs X 0 05 X 1 X NN 0 X 40 150kV 50 630mA 0 003 5 0s 0 5 b00mAs X 0 05 am
33. OO OO XX OO X O 2010 1 2 3 4 5 6 FAX 03 3210 OOOO A 4 O AAAocco 11 O
34. 1 1 2 1 2 1 7 63 2 1 2 1 7 7 OO OO OQ 1 2 1 7 FAX E mail 1 2 1 7
35. 2 5 6 1 2 30 3 3 4 4 1 0 5 500mAs X 0 05 X Ki gt
36. X X X X 19 1 4 2 2 2 2 1 1 X X X 1 XX X cm cm cm XX X 200
37. 3 2 1 25 25 OT O RH 2 3 4 X OO 2010 5 AAAAAA BBBBBB CCCCCC _ 83 6 6 7
38. __ 140kJ 200kHU 2 XX X cm 1 1 0 43cmX 43cm 401p cm 10 1 ii 3 XX X X 4 X 2
39. nOWWW IIh5 9 9 50 01 1t010 01012101 1t t0t 5 O W hh05 5 0 0 tt t0t nu htht5 W1W111111W OU It EU i 4 2 3 4 3 4 4 4 5
40. 1 3 ul rn AH XX 2010 XX 00 RIN 7 2 NN Ua 1 XX 0 2 0
41. cm cm cm X X 3 X 2 X X X 1 2 2 C JIOMMU OOOOHH 321p cm 14 1 Pin 21 O 1 3 D
42. 3
43. 2 3 4 37 7 2 5 6 38 2 1 2 3 2
44. 16 17 2 49 43 i 47 5 52 53 5 5 1 X
45. 0 X X 5 1 33 Sm 5 2 X 1 X 2 A OO OOOOOOOOOOOO SA AAA X 200 0000A0 6 X 300 X B OOOOOOO OO OOO HHHHHHH X JIRAD 17 XX 1 X
46. yy 8 a ie eee ri nn 55kW 65kW 55kW 65kW 55kW 65kW W TIS 2 4751 2 28 201 7 9 2 101 c JIS T 60613 9 30 lp m 30 35 DQAE 10 150 lp mm 50 51 52 MTF gt al 26 O 1 ok4hWet Pr 5 A C X X X SD
47. 7 15 a a 6 1 gt 2 gt 3 4 3 gt lt 4 5 6 gt 5 6 1 2 3 4 1 2 6 3 2 7 3 4
48. Sc PH yy MS MS gt 2 X MS19AOd J RE ER F zH09 08 VAM09 X i AO0Z EE nA nm ji Z vm iz x i 1 X 1 i me oo A001 X 24 1 9 X X X X X y 1 X X X 25 1 10 SI a
49. 31 2 4 6 40 09 _ O 2010 O OO
50. 5 NN 1 1 1 XX X
51. 3 KN ES 4 KG SU 5 6 3 1 2 EMC 4 1
52. 2 1 2 2 3 4 4 1 uo Whs5 8 WIIW WW
53. 4 le 5 123834567 OO JIS T 0601 1 JIS T 0601 1 2 JIS T 0601 1 3 JIS Z 4751 2 54 TIS T 14971 CU ABCXYZ safety test report 123456789 EMC test report 0987654321
54. SI et 1 1 1 1 X 2 X 3 4 5 6 7 1 X 8 X 1 X 1 X 2 X 2 3 X 2 X X 0 3 X 4 X OO O 5 OO O O O O 7 X 1 OO O O 8
55. XX oe Nd TT X 40 110kV 50 400mA 0 003 2 0s 0 5 200mAs X 0 05 0 Le 44 X X XX 0 6 1 2 0 7 1 2 0 3 0 8 55kW 65kW 55kW MI Au amZ
56. 5 6 OO FAX 03 3210 OOOO A 4 OH A AAcco a gt 1 ww
57. 2 OOOOOOOOOOO OO URI A X 1 J SPA RI EE a X 2 2 34 3 3 3 6 1 JISZ4751 2 54 203 6 4 3 104 3 JISZ4751 2 54 20
58. 203 6 4 4 104 4 JISZ4751 2 54 203 6 4 4 104 5 JISZ24751 2 54 203 6 4 4 104 6 10 10 0 2mAs ELF 1 10 0 2mAs X 0 05 A A2 A A2 e092 Lt 7 272 lt 7272 2 JISZ4751 2 54 203 6 3 2 101 X X Y Y 10 10 1 35 2 X Ki KAK 2 lt 0 2 iti 272 Ki gt X lit
59. 41 1 1 2 5 EpEE EE 5g2 8 4 10 TC 11 i I IRI 13 8 2 2
60. C OOOOOOOOOOOO HOOOO J A XX 1 OOOOHHHH B X 2 2 OO OO
61. Ki gt 0 0 2 X liti D2t2 kc 1 K gt X 2 72 31 4 2 200 0 6 1 2 300 0 6 1 2 200 55kW 300 65kW 2 X 32 A C X x X
62. X 1 O O 1 X OO 2 X 2 O O 3 X 2 17 1 2 1 2 XX X X SW 1 EE A X X X 2 18 1 3 2 2 1 X X X XX
63. 0 2 am 2 0 9 0 9 NAANANN IE ME XX X TINT ET 43 1 2 4 4 Meet
64. 7272 eo 2 i mGy mA S ti t2 0 1 NN X JISZ4751 2 54 203 6 3 2 102 a X TISZ4751 2 28 201 7 9 3 101 d JIS Z 4120 JISZ4751 2 28 201 7 9 2 101 O JIS T 60613 36 7 1 63 2 1 1
65. O OOOC 23 2 5 1 1 OO O 2 OO 3 X 201 0 1 2 3 4

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