通知本文はこちら（PDF） - 一般財団法人日本薬事法務学会
Contents
1.2. 1
3. 12
4. 4
5. 15
6. 5 1 5
7. 3 4 1
8. T Bl 5 7
9. 14
10. JIS T 14971 5 16 169 RG 6
11. O 16 169 O 16 169
12. a 4
13. 16 169 9 10 UIS 1 14971 2 1 NN
14. tt 0 2 1 8 1 8 2 JIS 1 14971 2 1 5 1 5 2 5 3 5 3 1 5 3 2 7 JIS T 14971
15. P 7 JIS T 14971 JIS T 14971 2 1 7 JIS T 14971 2 1 1 6 2 JIS T 14971 8
16. RR 2 5 2 1 0 0 0 5 2 2 DN 0 30mm 5 2 3 0 10mm 5 2 4 0 25mm 0 35mm 5 2 5 0 35mm 0 45mm 5 2 6 0 05 0 00mm 3 5 3 1 546 07nm Hg e
17. 2 1 6 2
18. JIS T 14971 16 l0216002 17 2 16 2 1 2
19. 10 25g g 1S0 10993 7 11 11 1 11 12 2 12 1
20. 2 lJIS T 14971
21. JUIS T 14971 1 2 1 5 1 5 2 2 1 8 2 i JIS T 14971 i gt JIS T 14971 E 3
22. 22 D 1 50 119792 1 D 6 0 0 3 50 lt Ous256 E04 lt Ds30 0 05 0 1 2 5 D UE 5 3 2 MTF 1 60 2 MTF 100 mm 0 43 MTF 709 MTF 0 28
23. 5 9 3 31 59 1 60 5 10 489 1 1 1 5 0mm lt 7 5mm 2
24. 2 1 19 7 2 1 9
25. 1 1 A CR ORE AR 2 2 1 ISO 11979 1 0Ophthalmic implants Intraocular lenses Part 1 Vocabulary IS0 11979 1 2 2 ISO 11979 2 Ophthalmic implants Intraocular lenses Part 2 Optical properties and test methods IS0 11979 2 2 3 ISO 11979 3 Ophthalmic implants Intraocular lenses Part 3 Mechanical properties and test methods ISO 11979 3 2 4 ISO 11979 4 0phthalmic implants Intraocular lenses Part 4 Labelling and information IS0 11979 4 2 5 ISO 11979 5 0Ophthalmic implants Intraocular lenses Part 5 Biocompatibility ISO 11979 5 2 6 15S0 11979 6 0Ophthalmic implants Intraocular lenses Par
26. 2 2 5 7 16 298 1 643 Se 17 4 1 1 1 2 1 3 4 2 5
27. 1 RN TE 16 169 JIS T 14971
28. 1 2 17 2 16 0216002 2 3
29. 2 3 N 0310003 17 3 10
30. ISO0 11979 2 5 3 3 300nm 800nm 1S0 11979 2 4 5 4 1 5 4 2 5 4 3 2 109 1S0 11979 2 0 MTF 5 4 4 2 5 ISO 11979 2 MTF 5 4 5 5 4 6 5 4 7
31. 14 96 2 14 1 19 2 1 17 2 16 0216002 4 2 17 3 31 0331012
32. 12 13 3 14 3 15 wow 0 CO wR RR CC
33. D 6 7 1mm mm 3 8 MTF Modulation Transfer Function mm 9 a 11
34. 2 1 7 JIS T 14971 2 1 2 gt
35. O 3 16 169 4 16 169
36. 5 5 5 17 3 10 10310003 9
37. 6 5 13
38. 7 1 7 2 7 3 7 4 7 1 7 4 9 1S0 11979 6 8 1 8 1 1 25 3 60 209 8 1 2 1S0 11979 6 8 2 9
39. 12 1 1 12 1 2 12 1 3 D 12 1 4 mm 12 1 5 mm 12 1 6 ee 12 2 12 2 1 12 2 2 12 2 3 12 2 4 D 12 2 5 mm 12 2 6 mm 12 2 7 12 2 8 12 2 9 A 12 2 10 Sterile 12 2 11 EXP dgate 2
40. 1 a Sb
41. 5 1 11 2
42. 4 5mm 3 4 5 6 7 8 20 0D 1 6mm 9 10 0mgf 30mgf 11 10 5mm lt 14 5mm 12 0mgf 30mgf 13
43. 0 25N 5 4 8 mgf 1S0 11979 3 5 5 3 24 2 RRO I 0 5 6 6 1 2 IS0 10993 12 UV
44. IS0 11979 5 2 y IS0 10993 12 UV 1S0 11979 5 3 Nd YAG Nd YAG Nd YAG 1S0 11979 5 7 gt gt
45. L Intraocular Lens 2 3 4 3 5 6 546 07nm Hg e 1 336 m
46. O O 17 4 1 0401036 60 5 10 489 35 145 14 1 19 2 1 14 9 19 2 5 IVD 1 1
47. t 6 Shelf Iife and transport stability IS0 11979 6 2 7 ISO 10993 7 Biological evaluation of medical devices Part 7 Ethylene oxide sterilization residuals IS0 10993 7 2 8 ISO 10993 12 Biological evaluation of medical devices Part 12 5 Sample preparation and reference materials IS0 10993 12 2 9 15 2 13 0213001 RR ki a ll 10 17 3 30 0330001 GMP QMS 4 4 11 10 3 31 353 1S0 11979 1 1 IO
Download Pdf Manuals
Related Search