別添2眼内レンズ承認基準（PDF：813KB）
Contents
1.2. 15
3. 3 2 1 6 2 4
4. 4
5. 14 2 3
6. 16 169 IS T 14971 0401036 17 4 1 2 1 8 1 W 8 2 JIS T 14971 2 1 5 1 5 2 5 3 5 3 1 5 3 2 1 0
7. 16 169 JIS T 14971 5 6
8. 4 e
9. 5 5 1 10
10. 0310003 17 3 10 JIS T 14971 0216002 17 2 16 2 1 2 CF
11. 2 3 4
12. 2 1 _ 5 5 17 3 10 0310003 9 JIS T 14971
13. JIS T 14971 3 16 169 4
14. 16 169 5 6 2 1 9
15. 2
16. ri eg JIS T 14971 2 1 7 JIS T 14971 2 1 7 JIS T 14971 JIS T 14971
17. 16 169 2 3
18. 8 6 7 J 1 2
19. MIF 7 2 1 9 8
20. 2 3 16
21. 2 _ 3 yh 10 0 2
22. 1 16 169 JIS T 14971
23. 2 1 5 1 5 2 2 1 8 2 JIS T 14971 _ JIS T 14971
24. 5 6 7 13
25. 2 1 7 4 5 JIS T 14971
26. 5 11 2
27. 10 25 g g tSO 10993 7 11 11 1 11 2 12 12 1 12 1 1
28. 3 4 5
29. 5 2 5 2 1 0 10mm 5 2 2 0 20mm 0 30mm 5 2 3 0 10mm 5 2 4 0 25mm 0 35mm 5 2 5 0 35m 0 45mm 5 2 6 0 05 0 00mm 5 3 5 3 1 546 07nm Hg e
30. 2 D 1 1SO0 11979 2 1 Dr 15 0 lt D 25 0 0 4 D 1 2 5 3 2 MTF 1 60 2 MTF 100 mm 0 43 MTF 70 MTF 0 28 TS0 11979 2
31. 1 1 2 2 1 1S0 11979 1 Ophtha1mic implants Intraocular 1enses Part1 Vocabulary iSO 11979 1 2 2 ISO 11979 2 Ophtha mic implants Intraocular lenses Part 2 Optica1 properties and test methods ISO 11979 2 2 3 IS0 11979 3 OphthaJmic implants Intraocular lenses Part 3 Mechanica1 properties and test methods IS0 11979 3 2 4 IS0 11979 4 Ophthalmic implants Intraocular lenses Part 4 Label1ing and information TSO 11979 4 2 5 1S0 11979 5 Ophthalmic implants Intraocular 1enses Part 5 RAE IS0 11979 5 2 6 TSO 11979 6 Ophthalmic implants Intraocular lenses P
32. 2 _ 3 4
33. IS0 11979 5 6 2 IS0 10993 12 UV A IS0 11979 5 6 3 Nd YAG Nd YAG Nd YAG ISO 11979 5 7 7 1
34. mgf IS0 11979 3 5 4 gt 5 5 ER 3 24 2 6 6 1 2 ISO 10993 12 UV
35. 16 169 9 10 JIS T 14971
36. 1IS0 11979 1 I OL Intraocular Lens i 10 11 12 14 15
37. 7 2 7 3 7 4 7 1 7 4 8 rd so 11979 6 8 1 8 1 1 25 3 C 60 20 8 1 2 ISO 11979 6 8 2 9
38. 7 5 2 3 8
39. 12 1 2 12 1 3 D 12 1 4 mw 5 mm 6 Steri1e 42 1 12 12 2 12 2 1 12 2 2 12 12 12 12 12 12 12 12 12 3 4 D 5 mm 6 mm 7 8 9 A 10 Steri1e 11 EXP date 2 9
40. 2 1 6 1 6 2 6 JIS T 14971 i _ 8
41. 2 2 5 7 16 298 1 643 646 17 4 1 1 1 2 1 3 4 2 5
42. 5 3 3 300nm lt 800nm 1SO 11979 2 5 4 5 4 1 5 4 2 5 4 3 2 109 1S0 11979 2 MTF 2 5 ISO 11979 2 MTF 5 4 5 5 4 6 5 4 7 0 25N 5 4 8
43. 546 07nm Hg e 1 336 _ m D 1 m mm MTF Modulation Transfer Fmction Gg ds dE EC OS mm
44. art 6 Shelf life and transport stability ISO 11979 6 2 7 TSO 10993 7 Biological evaluation of medical devices Part 7 Ethylene oxide sterilization residuals ISO 10993 7 2 8 1SO 10993 12 Biologica evaluation of medical devices Part 12 Sample preparation and reference materials ISO 10993 12 2 9 15 2 13 0213001 2 10 17 3 30 0330001 GMPQMS 4 4 2 11 10 3 31 353 3 CR co 1
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