高度医療審査の照会事項（山口構成員）に対する回答（1）
Contents
1.2.
3. DD
4. 9 20mm
5. A
6. mi
7. IT IT
8. lt gt A 35 50 2 8mm 0 a a 1400mm 1800mm 3 5mm 5 0mm 1 EOG 1 B 6 A P P EER a SA 2 JIS T 0601 1 1999 I
9. ESD Gotoda SAE SAE 11 99 1 3 2 IT IT ESD SAE Gotoda 11 9
10. 6 Ck j 7 i 12 9 9 rs
11. SAE step 1 4 ESD 30 2 3 24 3 14
12. J EE gt 15 2 4 gt 1400mm 2 8mm A P P 175W 500kHz 1 5kVp p gt
13. 3 374 gt 10 45C 30 95 RH 70 106kPa gt 3 4 1 TT a
14. 3 En 2 3 4 1 5 3 tm samk
15. 1 4 3 ESD SB ESD IT ESD IT
16. ESD IT 2 IT
17. SAE IT ESD ES5D IT ESD gt ESD SAE 30 2 3 24 3 14 IT ESD ESD IT ESD SAE Gotoda 11 9 SAE 0 5 4 4 5 IT
18. iy lo ie RN 19 2 21 MD 48518 374
19. 1000C ESD Step 1 CRF
20. t o lt
21. IEC60601 2 18 IEC60601 2 18 gt E
22. 1 0t1 8510 274 018 846 689 31 110 iMR C6 T2 2010 2010 7 1 2 222AABZX00008000 1 18 1 I TU 25 JMDN 70164020 DP2618DT 35 50 a
23. ESD 3 SAE 11 9 2006 SAE 11 9 SAE 11 9 SAE 3 ESD 11 99
24. PS 3 6 7 ue 9 10
25. 23 2 23 24 7 23 6 gt 490 DR OER 1
26. A M oH r 11 12 13 14 6
27. El 31 110 MRTCE T2 TE B 3 p 3
28. 12 13 74 14 15 1 ESD
29. i169 3 17 19 20 1 2
30. 2 3 24 3 14 4 SB DP2618DT 4 SB DP2618DT 2
31. 700Vp 2500vp 1 a G ja 31 110 MRTCB8 T2 0 0 2
32. ESD 4 Step 1 SB 010 10 1 2 e009 5 1H 1 C61 AABZXD0044000 G5 70164080 SB 1 2 3
33. MD 47523 MD 47533 MD 47523S MD 47833S 5 50ml 0 MD 4B518 MD 48518 2 MD 48718 3 SB MD 47910 MD 47820 MD 47930 MD 47940 lt gt 3 3 a 4 Ve 5s 6 sett A
34. 4 1 SAL SAL 10 33 11G MRTC6 H2 RSD TE RE TD Pe 1 3m gt 23mml ERBE CC200 ERBE VIO300D eg ERBE No 20192 II7
35. SB 200 200 0 40 0 60 0 31 0 35 0 32 0 36 Ma 5000 2000 10 15 15 20 14 19 30 2 3 24 3 14 10 Q cm 10 GPa SUS304 5 GPa 1000C
36. SAE 11 9 ESD ESD ESD Gotoda SAE 30
37. 798 TEL 0120 771669 26 30 TEL 03 6419 8033 4 4 FF825A 6 202B1223439A 1007 2 0 FS 30 2 3 2 Endoscopic Submucosal Dissection ESD 2012 3 2 1 1 1 1 Step 2 INS
38. 4 1 Gotoda IT ESD SAE ESD
39. BF A gt gt gt 1
40. 2 IT ESD ESD ESD SAE 30 2 3 24 3 14 3 SB 1 SB
41. RN 3 4 72 5 Me 6 SD 3 10
42. SAE 11 9 SAE SAE ESD Gotoda ESD 100 ESD ESD 10 20 Gotoda ESD SAE 15 2005 4 9 2007 10 1 2008
43. 13 19 11 v MD 1 12 rS HE 13 14 MD 47704 7708 ST p et 4 5 a 8 HH 3 16 lt 17
44. y 200mm E 1 8 E E 3 1 E 4 3 E SS 5 P A
45. 30 2 3 24 3 14 1 Endoscopic Submucosal Dissection ESD 24 3 1 1 Endoscopic Submucosal Dissection ESD step1 2 1 5 3 1001 2
46. 1 ESD 30 2 3 24 3 14 2 3 3
47. 11 12 4 140 5
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