眼科用レーザ光凝固装置承認基準の制定について（PDF：1266KB）
Contents
1. 2 JTS T 0601 36 2022. 16 169 16 169 J
3. 16 169 16 169 JIS T 14971
4. 4 4 JIS 14971 18 3 31 0331018 1 4 4 JES T 14971 IS T 0601 1 1
5. 18 3 31 0331018 1 4 5 18 3 31 0331018 1 4 5 9
6. JIS T 14971 for the safety of diagnostic and therapeuttc laser equipment 19 Continuous LEAKAGE CURRENTS and PATIENT AUXILIARY CURRENTS 52 Abnormal operation and fault condition 56 Components and general assembly 57 MAINS parts components and jayout JIS T 0601 1 1 21 22 23 24 25 28 JIST 0601 1 1
7. 1 6 2
8. 1 4 4 4 5 17 3 10 0310003 JIS T 14971 17 2 16 0216002 2 1
9. 3 1 4 9 6 2 1 4 1 1 9 2 1 1 7 2 1 6 0216002
10. te 15
11. 10 9
12. 16 169 4 _
13. 4 5 6
14. 1 97 MAINS parts components and ayout JIS T 14971 JIS T 060 1 1 6 8 2 j JIS T 14971 1 4 4 2 JIS T 14971 5 1 4
15. _ 4 5 6
16. 6 7 J 8
17. 1 W 20 2 W 20 3 1000mW 1000mW 0 2 500 500 1 20 4 6 5 W cm 4 6 6
18. 4 2 1 7 3 3 1 0331012 2 5 7 1 6 2 9 8 1 9 1 9 1 8 3 3 1 1 2
19. 3
20. 1 2 4 4 4 4 1 1 2 3 4 5 Hz
21. 3 4 6 11 4 6 4 4 6 5 4 6 7 4 6 1 0 4 6 12 4 7
22. 36 201 JIS T 0601 1 2 1 2 36 202 1 7 JIS T 0601 1 1 7 13 14 15 16 17 18
23. 7 8 1 2
24. 2 Particuiar requirements IEC 60601 2 22 Medical JIS T 0601 1 2 1 2
25. 2 PE lr
26. 2 3 4
27. 16 169 JIS T 14971 JIS T 14971 1 4 6 3 4 6 4 4 6 5 4 6 6 4 6 7 4 6 8 4 6 9 4 6 10 4 6 11 7 ee
28. 50 10 0 1 50 50 10 0 50 4 6 7 13 5 20 100 um 50 bin 4 6 8
29. 1BC 60601 2 22 6 8 IEC60601 1 2 6 8 201 4 IEC 60825 1 6 1 0 4 7 6 1 4 95 4 6 4 6 1 IEC 60601 1 4 6 2 CW 4 6 3 488nm 514nm 521nm 531nm 532nm 561nm 568nm 575 680nm 788 828nm 4 6 4 2
30. 1 7 3 3 1 0331018 2 1
31. 2 IEC 60601 2 22 Medical electrical equipment Part 2 Particular requirements for the safety of diagnostic and therapeutic laser equipment 49 Interruption of the power supply 52 Abnormal operation and fault condition TIS T 14971 3 4 J 6
32. JIS T 7316 JIS T 7306 4 6 9 0 ep 50 mn nO 4 6 10 1 1 2 1
33. JIS T 0601 1 1 42 JIS T 14971 IEC 60601 2 22 Medica1 electr cal equipment Part 2 Farticular requirements for the safety of diagnostic and therapeutic laser equipment 00 Accuracy of operating data EEC 60601 2 22 Medical electrical equipment Part 2 Particular requirements for the safety of 1 diagnostic and therapeutic laser equilpment 51 Protection against hazardous output 52 Abnormal operation and fauilt condition 1 4 4 2 1 2 3
34. 18 3 31 0331018 1 4 4 JIS T 14971 0 1 1 43 1 18 3 31 0331018 1 3
35. 3 4 hh 5
36. 2 Hp Rt JIS T 14971 JIS T 0601 1 1 43 Pe 18 3 31 0331018 1 4 4
37. 56 3 a 5 14 2 3
38. JIS 16 169 JIS T 14971 JIST 0601 1 1 7 1 JIS T 14971 3
39. 3 1 3 2 3 3 8mm W mW 3 4 3 5 3 6 3 7
40. 56 11 d JIS T 14971 8 2
41. 0331016 18 3 31 E 3 5 1 4 5 1 4 1 1 9 2 1 OO 1 4 9 1 9 2 5 0 1 VD 1 1 7 2 1 6 0216002
42. 1 56 11 3 JIS T 14971 JIS T 14971 JIS T 0601 1 1 25 42 43 57 57 10 59 IPC 60601 2 22 Medical electricai equipment Part 2 Particular requirements for the safety of diagnostic and therapeutic laser equipment 52 Abnormal operation and fauit condition 56 Components and general assembly 3 10
43. 4 4 1 IEC 60601 1 TEC 60601 1 1 IEC 60601 1 2 TIEC 60825 1 JIS T 0601 1 JIS T 0601 1 1 JIS T 0601 1 2 JIS C 6802 4 2 4 2 1 IEC 60601 1 IEC 60601 1 2 E BF _ 4 2 2 IEC 60601 1 1 4 3 4 3 1 IEC 60825 1 8 2 4 3 2 TEC 60825 1 4 2 4 3 3 IEC 60825 1 4 3 4 3 4
44. 1 3 4 2 5 1 1 2 JIS C 6802 JIS T 0601 1 1 JIS T 0601 1 1 1 1 JIS
45. 0601 1 2 1 2 JIS T 7306 JIS T 7316 TEC 60601 1 Medical electrica equlpment Part 1 General requirements for safety TEC 60601 1 1 Medical electrical equipment Part 1 1 General requirements for safety Collateral standard Safety requirements for medical electrical systems TEC 60601 1 2 Medical electrical equipment Part 1 2 General requirements for safety Collateral standard Electromagnetic compatibility Requirements and tests EEC 60601 2 22 Medical electrica equipment Part 2 Part1cular requirements for the safety of diagrnostic and therapeutic laser equipment TEC 60825 1 Safety of jaser products Part 1 Equipment classificatior requirements and user s guide 4 7 6 1 4 9 5 1 7 3 1 0 0310003 18 3 31 0331018 3 JIS T 0601 1 TIS T 0601 1 2 ISC 6802
46. EEC 60825 1 4 4 4 3 5 IEC 60601 2 22 4 9 2 4 3 6 IEC 60825 1 4 5 4 3 7 IEC 60601 2 22 3 2 d e 4 3 8 IEC 60825 1 4 7 4 3 9 IEC 60825 1 5 1 5 6 JIS C 6802 5 1 5 6 4 3 10 IEC 60601 2 22 6 1 bb JiIS C 6802 5 7 4 3 1 1 IEC 60825 1 5 8 5 1 1 JIS C 6802 5 8 5 1 1 4 3 12 IEC 60601 2 22 5 1 1 0 1 4 3 13 IEC 60601 2 22 56 1 0 1 4 3 14 IEC 60601 2 22 56 1 1 4 3 15 IEC 60601 2 22 3 2 59 10 1 4 3 16 4 3 17
47. V 6 A amp VA WD 7 HI TIEC 60601 2 22 6 4 4 2 1 EEC 60601 2 22 6 4 4 1 2 IEC 60601 1 2 6 1 20 1 4 5 1 2 1 7 3 10 0310003 3
48. 20 58 59 electrical equipment Part 13 2 3 4
49. 4 2 1 11 2 _
50. IS T 14971 17 3 10 0310003 TIS 14971 17 3 10 0310003 JIS T 0601 1 1 1 1 TIS T 14971 JIS T 0601 1 1 10 2 2 21 22 23 24 25 IEC 60601 2 22 Medical eiectrical equipment Part 2 Particular reqguireme
51. nts for the safety of diagnostic and therapeutic aser equipment 56 11 Cord connected hand held and foot operated control devices JIS T 14971 JTS T 0601 1 1 10 2 2 IEC 60601 2 22 Medica1 electrical equipment Part 2 Particular requirements for the safety of diaghostic and therapeutic laser equipment 49 Tnterruptioh of the powey suppliy JIST 0601 1 2 1 TE EIT EIT tt 2
Download Pdf Manuals
Related Search