厚生労働省`医薬食品 眼科用 レーザ光凝固装置承認基準の制定について
Contents
1.2. JIS JIS T 0601 1 1 7 1 JIS T 14971
3. 3 4
4. 6
5. 3 16 169 4
6. 18 3 31 0331018 1 4 5 7 18 3 31 0331018 1
7. JIS T 0601 1 10 2 2 21 22 23 24 25 EC 60601 2 22 Medical electrical equipment Part 2 Particular requirements for the safety of diagnostic and therapeutic laser equipment 56 11 Cord connected hand held and foot operated contro1 devices J1S T 14971 JIS T 0601 1 1 10 2 2 IEC 60601 2 22 Medical electrica equip
8. 2 36 202 JIS T 0601 1 1 56 11 d JIS T 14971 JIS T 14971 JIS T 0601 1 1 25 42 43 57 57 10 59 IEC 60601 2 22 Medica1 electrical equipment Part 2 Particular requirements for the safety of diagnostic and therapeutic laser equipment 52 Abnormal operation and fault conditi
9. JIS T 0601 1 1 21 22 23 24 25 28 3 3 4
10. JIS T 0601 1 1 6 8 2 j J1S T 14971 3 4 1
11. 1 2 IEC 60601 2 22 Medical electrical equipment Part 2 Particular requirements for the safety of
12. 2 3 1
13. 4 4 1 IEC 60601 1 IEC 60601 1 1 IEC 60601 1 2 IEC 60825 1 JIS T 0601 1 JIS T 0601 1 1 JIS T 0601 1 2 JIS C 6802 4 2 Me 4 2 1 TEC 60601 Ce 60601 1 2 BEF 4 2 2 TEC 60601 1 1 4 3 4 3 1 1EC 60825 1 8 2 4 3 2 IEC 60825 1 4 2
14. 16 169 ee 2
15. 4 6 8 JIS 1 7316 JIS T 7306 4 6 9 50 1 5 OR 4 6 10 1
16. TIEC 60601 2 22 6 8 IEC60601 1 2 6 8 20 1 4 IEC 60825 1 6 1 0 4 7 6 1 4 9 5 4 6 4 6 1 IEC 60601 1 4 6 2 CW 4 6 3 568nm 575 680nm 788 828nm 450 700nm 4 6 4
17. 1 2 1 3 4 6 1 1 4 6 4 4 6 5
18. 7 JIS T 14971 J
19. 1 JIS T 14971 2
20. 16 169 9 16 169 JIS T 14971 10
21. 4 4 JJS T 14971 3
22. 5 Emi 6 a 7 8
23. 17 3 10 0310003 JIS T 14971 17 3 10 0310003 JIS T 0601 1 1 1 1 9 JIS T 14971
24. JIS T 14971 JIS T 14971 6 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
25. 4 4 4 5 17 3 10 0310003 JIS T 14971 16 17 2 16 0216002 2 1 2
26. 6 JIS T 0601 1 1 56 11 d IIS T 14971 8
27. 16 169 JIS T 14971 5 16 169
28. 2 1 3 4 2 5 1 1 2 JIS C 6802 JIS T 0601 1 1 JIS T 0601 1 1 1
29. 4 5 18 3 31 0331018 1 4 4 JIS T 14971
30. JIS T 0601 1 2 1 6 7 2 36 201 JIS
31. 3 4
32. W cm 4 6 6 50 10 0 1 50 50 10 0 1 50 4 6 7 13 5 20 100 mn 50
33. 4 3 1 7 1 2 4 4 4 4 1 AR SN i 3
34. 4 4 2 1 JIS T 14971 5 1 4 4 2 1 1 1 2
35. JIS T 0601 1 1 56 3 a JIS T 14971 5 JIS T 0601 1 1 42 JIS
36. 2 3 1 4 WW 9 6 2 1 4 1 1 9 2 1 1 7 2 1 6
37. 4 5 8
38. 2 Particular requirements for the safety of diagnostic and therapeutic laser equipment 51 Protection against hazardous output 52 Abnormal operation and fauit condition 3 1 4 4 2 1 1 5
39. 3 0 JIS T 0601 1 JIS T 0601 1 2 JIS C 6802 3 1 3 3 2 3 3 8mm W mW 3 4 3 5 3 6 3 7
40. 4 5 Hz V 6 A VA WW 7 I IBC 60601 2 22 6 4 4 2 1 IEC 60601 2 22 6 4 4 1 2 IEC 60601 1 2 6 1 2 0 1 4 5 1 2 1 7 3 1 0 0310003 3
41. 0216002 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
42. 1 2 3W 5mW 4 3 15 1 W 20 2 W 20 3 1000mW 1000mW 0 2 500 500 1 20 4 6 5
43. 0331016 1 8 3 3 1 3 5 1 4 5 1 4 1 1 9 2 1 1 4 9 1 9 2 5 I VD 1 1 7 2 1 6 0216002
44. 1 JIS T 0601 1 2 1 2 JIS T 7306 JIS T 7316 TEC 60601 1 Medica electrical equipment Part 1 General requirements for safety TEC 60601 1 1 Medical electrica equipment Part 1 1 General requirements for safety Collateral standard Safety requirements for medical electrical systems TEC 60601 1 2 Medica electrical equipment Part 1 2 General requirements for safety Collateral standard Electromagnetic compatibi ity Requirements and tests TEC 60601 2 22 Medical electrical equipment Part 2 Particular requirements for he safety of diagnostic and therapeutic laser equ1pment EC 60825 1 Safety of 1aser products Part 1 Equipment classification requirements and user s guide 4 7 6 1 4 9 5 F 1 7 3 1 0 0310003 F 1 8 3 3 1 0331018 J
45. 4 6 7 4 6 1 0 4 6 12 4 7 1 7 3 3 1 0331018 2 1 16 169
46. 4 3 3 IEC 60825 1 4 3 4 3 4 IEC 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 TEC 60825 1 5 1 5 6 JIS C 6802 5 1 5 6 4 3 10 IEC 60601 2 22 6 1 bb JIS C 6802 5 7 4 3 1 1 IEC 60825 1 5 8 5 1 1 JISC 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 5 6 1 0 1 4 3 14 IEC 60601 2 22 56 1 1 4 3 15 IEC 60601 2 22 3 2 f 5 9 1 0 1 4 3 16
47. diagnostic and therapeutic 1aser equipment 49 Interruption of the power supply 52 Abnormal operation and fault condition JIS T 14971 2 3 4 5
48. T 0601 1 2 1 2 36 202 JIS T 0601 1 1 7 13 14 15 16 17 18 20 58 59 IEC 60601 2 22 Medical electrical equipment Part 2 Particular requirements for the safety of diagnostic and therapeutic laser equipment 19 Continuous LEAKAGE CURRENTS and PATIENT AUXILTARY CURRENTS 52 Abnormal operation and fau1t condition 56 Components and general assembly 57 MAINS parts components and layout 13 2
49. T 14971 1 4 IEC 60601 2 22 Medical electrical equipment Part 2 Particular requirements for the safety of diagnostic and therapeutic 1aser equipment 50 Accuracy of operating data 2 IEC 60601 2 22 Medica1 electrical equipment Part
50. IS T 0601 1 1 43 8 3 31 0331018 1 4 4 38 3 31 0331018 1 4 4 JIS T 14971 JIS T 0601 1 1 43 1 2 18 3 31 0331018 1
51. ment Part 2 Particular requirements for the safety of diagnostic and therapeutic laser equipment 49 Interruption of the power supply JIS T 0601 1 2 1 2
52. on 56 Components and general assembly 57 MAINS parts components and layout JIS T 14971 3 2 10
Download Pdf Manuals
Related Search