Page 1 Page 2 Page 3 Page 4 Page 5 (2) 平成 24年4月~平成 25年3
Contents
1. HAPI TV TBS 30 8 5 5 30 6 00 6502. PMDA JMDN WG WG W
3. 1 5 000 1 3 1 1 3 1 1 1 000 1 000 1 1 1 2 i 1 5 000 1 1 1 1 1 1 a 4 1 20 21 22 23 24 415 578 667 576 645 60 55 61 52 73 475 628 728 628 718 2
4. 4 5 23 1 8 25
5. 4 No 1 4 6 2 7 3 8 4 ANx 5 1 2 3 25 1 3 8 24 11 22 1 25 2 25
6. es 4 2 3 4 5 6 7 8 9 10 5 1 JIS T 2001 2 JIS 2 4 6 20 9 8 10 18 1 22 3 1 JIST 2001 JTS C 9835 2 27
7. F S 3 Pl 4 y 3 AA _ 5 D JMDN WG 7
8. 2 QMS ISO 13485 QMS TSO 18485 QMS 2013 5 16 17 ISO TC 210
9. 2012 2012 9 10 9 12 3 10 17 3 21 1 25 370 2 0 1 3 3 13 3 15 3 10 17 3 21 1
10. WG WG WG 2 WG WG 20 WG 6 PMDA PMDA Web FD FD A Eo
11. 32 1 1 WG 1 WG 2 3 4 5 7 6 8 9 2 i 9 11 11
12. 12 a 13 14 z4 0 a 15 18 19 20 K 21 wx 1 2 3 2 3 5 1 24 2 14
13. 6 1 2 NITE 5 4 6 8 9 4
14. 3 HAPI 20 121 6 364 26 881 7 194 21 138 7 258 41 1 298 8 556 22 115 6 044 38 1 194 7 238 28 111 5 839 28 879 6 717 24 161 8 444 25 800 9 244 HAP1 HAPI HAP T HAPI
15. JIS JIS 0601 1 2012 JIS T 0988 1 2012 JIS T 14971 2012 Bulletin ISO IEC 17021 JTS Q 17021 ISO IEC 17065 JIS Q 17021 6 1 1 2 2 9 4 18 5 30 6 18 7 11 9 12 11 20 25 1 25 2 22 8 22 3 D
16. 3 4 5 DD T D 4 1
17. 0830 8 24 8 30 24 12 14 QM8 2 WG WVG WG 4 No 6 nA7 5 1
18. WG GHTF SG2 11 12 6 93 98 JMDN GMDN JMDN 2009 23 JMDN GMDN 5 A RCB
19. HAPI 4 No 77S TI i ey Ax M2 1 Q 2 2 3 9 25 10 29 1 18 3 1
20. JMDN WG 7 PMDA JMDN
21. Q amp A WG 4 MI A fy JIS JIS 1 1 JIS 2 3 4 2 3 5 10 9 28 12 6 3 1 JTS JIS T 2001 JIS T 2002
22. 4 No 1 2 MIRIC 3 4 5 gt 6 7 3 5 17 23 24 2012 DD 2018 24 24 11 25 2
23. No No 1 4 2 5 3 6 1 1 2 8 2 5 5 23 7 26 9 14 11 13 2 5 3 2006 253 200mT 119 65 9 55 4 4 1 2 1
24. 3 1 2 24 1 4 0 3
25. 8 15 12 22 8 3 Q amp A 9 4 23 7 10 16 10 13 17 1 81 18 4
26. 1 JIS T2002 2006 2 3 3 4 16 7 17 10 17 1 JIS T 2002 2006 PMDA JIS 2 JIS T 2002 JTS 3
27. 9 45 000 40 000 1 je 9000vr MAAAASL 140 120 7 000 100 000 80 5 000 60 4 000 022 3096 3203 3 227 We D546 2539 2 000 20 000 i 0 H18 a 922Z 8588 3998 H18 H19 H20 H21 H22 H23 H24 1 2 1 10 26 14 16 2 6 12 14 15 17 2 QMS
28. CS 8 yy 7 A4 XX Cs CS y y7 E271 Y y WG WG JIS JIS 7 JIS
29. 2 1 2 4 1 1 23 DD 2 3 4 4 No No 1 5 2
30. 2 WG JIS 3 WG 2 8 8 2 4 WG 4 5 25 9 21 11 16 3 11 WG 4 5 17 9 1 11 19 2 20 WG 5 4 20 9 20 11 12 1 10 2 21 3 1 WG 8 2
31. He 1
32. 43 3 682 47 3 635 1 1 18 1 12 4 26 20 26 6 1 31 EEH 56 10 658 291 10 367
33. 5 2012 9 6 D 40 12 14 2013 25 25 40 25 25 25 H to 14
34. 1ISO 14971 2007 JIS T 14971 2012 2012 3 1 2018 8 11 15 TO 210 3 24 5 100 100 11 NITE Web Web
35. 5 4 Me E zj a ss ERE gmss Tea nn El 25 4 1 JIS JIS JIS G Ws ISOATC210
36. 6 25 37 239 57 52 60 31 7 139 8 179 7 JIS JIS T 2001 JIS T 2002 JTS WHO PMDA JTS IEC 60335 2 32 IEC 60335 2 60
37. 7 16 8 G4ryWw277 17 A 9 B FyA 18 Ey 1 2 T 2 8 11 3 1 2 3 No
38. 4 5 PMDA PMDA 2 NITE WG8 NITE 24 4 2 23 10
39. MTG OSG 7 9 2 29 YX787 2 SPC MIRIC 3 6 TOTO N
40. 4 50 000 5 000 50 000 JET 3 30 300W 2 JIS JIS 9 28 JIST 2001 PMDA 4
41. WG 2 23 8 25 43 8 685 3 500 10496 111 2 20 6 26 56 10 367 9 500 108 106 3 25 2 4 No 1 2 3 4
42. 6 60 66 5 20 22 23 24 52 27 16 16 20 21 6 18 7 1 24 35 19 42 22 15 4 L 9 479 48 29 79 22
43. 2013 2018 25 25 227 G 8 25 JAPAN 2018 24 25 4 10 25 4 11 40 6 5 HAPI ce 2 1 1 WG
44. 39 000 14 24 24 10 23 1 15 1 6 6 28 1 24 224 6 6 23 2012 24 24 1
45. WG 8 8 2 4 mo EE 6 7 8 11 bl 1 1
46. 6 z 3 7 08SG 4 8 TOTO 3 1 D 2 3 2 1 1 23 3 1 PMD A N 1 TE 4 2 3 4 ET 1 2 4
47. Web TPMDA Web FD Web 3 24 3 8 1 WG WG WG 37 WG 4 WG 11 15
48. 2 10 30 3 26 3 2 4 1 2 8 4 10 5 11 6 9 1 2 2 WG 2 4 24 6 20 3 1
49. 25 JAPAN 2018 24 25 25 4 No kwx 2 3 4 4 13 5 14 6 15
50. 2 3 2 3 4 20 5 24 7 28 3 1 2 3
51. 24 24 4 1 25 3 31 1 47 3 3 48 8 1 6 4 1 17 8 1 24 4 1 2 48 33 31 64 49 39 53 gt 92 50 44 70 114 60 56 108 159 5 98 89 187 7 108 67 4 179 20 74 32 4 110 21 72 28 5 105 22 68 25 5 98 28 67 25 4 96 24 64 29 6 99 1 64 gt 1
52. 24 4 25 3 gt amp 16 17 10 0 0 0 8 0 8 9 0 9 35 0 s5 68 0 68 96 0 96 4 2 6 11 0 HAPT 9 0 9 3 0 3 12 0 12 15 0 15 46 1 47 3 0 3 27 0 27 0 4 4 a i 51 0 51 1 _n 1 11 11 2 0 2 31 0 31 0 11
53. 2 6 JIST 0601 1 1 2012 6 1 JIS T 0601 1 3 3 PMS
54. 2 2 WG 3 WG 1 hi 4 No 12 2 8 MW 3 5 6 7 8 9 10 11
55. 1 2 24 225 10 12 40 i 24 4 9 24 8 30 120 91 3 3 24 8 30 121 25 25 G 226 1 11
56. 2 NIKKEN 3 gt 4 5 7 1 1 2 2 1 3 19 3 JIS 9 14 2 4 No No 1 5 2 6 7 gt 3 7 4 8 1 1 2 2
57. IKKEN 066 Y
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