眼科用パルスレーザ手術装置承認基準の制定について
Contents
1. 1 52. JIS TT 14971 JIS T 0601 1 1 ME IEC 60601 2 22 Medical electrical equipment Part 2 Particular requirements for the safety of diagnostic and therapeutic laser equipment 49 jnterruption power supply of the 1 JTS T 0601 1 2
3. 36 202 JIS T 0601 1 1 7 13 14 15 16 17 18 20 58 59 EC 60601 2 22 Medica1 electrical equipment Part 2 Particular requiretgents for the safety of diagnostic and therapeutic 1aser equipment 19 Continuous LEAKAGE CURRENTS and PATIENT AUXILIARY CURRENTS 52 Abnormal operatiort and fault condition o6 Components and general assembfy 57 MAINS parts components and layout 1 3
4. JIS T 0601 1 56 11 d Vs 1 JIS T 14971 2
5. 3 4
6. 9 17 3 10
7. 1 14 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 4 6 12 7 JIS T 14971
8. 3 _ 4
9. 20 100 mm 50 4 6 9 20 100gm 50 4 6 10 JIS _T 7316 4 6 11
10. 5 JIS T 0801 1 2 1 2 36 201 6 JIS T 0601 1 2 1 2 7
11. 2 3 9 6 2 1 4 1 1 9 2 1
12. 10 2 4
13. 2 1
14. JJS T 0601 1 1 21 22 23 24 25 28 2 3 4
15. 50 1 5 4 6 12 1 4 6 13 _
16. 5 _ JIS T 0601 1 1 56 3 a TS T 060 1 1 42 14
17. JIST 0601 1 1 43 JIS T 14971 JIS T 0601 1 1 43 1 2
18. JIS T 14971 16 169 5 JIS T 14971 JIST 14971 6
19. 1 4 4 2 1 15 MR
20. 9 10 JIS T 14971
21. 16 169 TIS T 14971 JIS 1 JIS T 0601 1 7 1 JIS T 14971
22. 3 2 1 4 4 4 5 17 3 10 0310003
23. 5 _ 6 7
24. 2 2 3 4
25. 3 16 169 4 16 169
26. IEC 60601 2 22 Medical electrical equipment Part 12 Particular reguirements for the safety of diagnostic and therapeutic aser equipment 50 Accuracy of operating data 2 IEC 60601 2 22 Medical electrical eauipment Part 2 Particular reguirements for the safety of diagnostic and therapeutic laser equipment 51 Protection against hazardous output 52 Abnormal operation and fault condition 3
27. gt 2 1 3 4 2 5 1 1 2 JIS C 6802 JIS T 0601 1 1
28. 2 4 4 4 4 1 d 2 3 4 5 Hz V 6 4 VA W 7 IEC 60601 2 22 6 4 4 2
29. 5 d 209 4 6 5 J cm 4 6 6 1Ins 10ns 50 20 4 6 7 3HBz 4 6 8
30. 5 6 8
31. 8 rm 1 2 IEC 60601 2 22 Medical selectrical equipment Part
32. JTS C 6802 5 7 4 3 1 1 IEC 60825 1 5 8 5 1 1 TJISC 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 f 5 9 1 0 1 4 3 16 3 17 1
33. 1 EC 60601 2 22 6 4 4 1 2 IEC 60601 2 22 6 1 20 1 4 5 3 2 1 7 3 1 0 0310003 3 TIEC 60601 2 22 6 8 IEC60601 1 2 6 8 201 4 IEC 60825 1 6 1 0 4 7 6 1 4 9 5
34. 4 6 4 6 1 LIEC 60601 1 4 6 2 4 6 3 4 6 4 1064nm 20mJ mW 1 mJ 20 2 509 100 1 20 3
35. 1 7 2 1 6 0216002 4 2 1 7 3 3 1 0331012 2 5 7 1 6 2 9 8 1 9 2 0 1 8 3 3 1 1
36. 6 7 8
37. 25 42 43 57 57 10 59 rc 6060 2 22 Medical electrical equipment Part 2 Particular requiremerits for the safety of diagnostic and therapeutic laser equipment 1 52 Abnormal operation and _ fault condition S6 Components and general assembly So7 MAINS parts componhents and layout JIS T 14971 1 3 JIS T 0601 1 1 6 8 2 3 JHS 1 14971
38. JIS T 14971 1 6 17 2 16 0216002 2 1 2
39. 2 0
40. 12 Particuiar requirements for the safety of _ diagnost1c and therapeutic laser equipment 49 fnterruption of the DOWeT suppiy 52 Abnormal operation and fault condition HS T 14971 2 3 4
41. 0310003 JTS T 14971 JIS T 0601 1 1 10 2 2 21 22 23 24 25 TEC 60601 2 22 edica1 electrical equipment Part 2 Particufar requirements for the safety of diagnostic and therapeutic laser eqguipment 56 11 Cord connected hand held and foot operated corntrol devices
42. 0331014 1 8 3 31 3 5 1 4 5 1 4 1 1 9 2 1 1 4 9 1 9 2 5 1 VD 1 1 7 2 1 6 0216002
43. 3 1 4 4 2 JIS FT 14971 5 1 1 1 4 4 2 1
44. 3 3 2 3 4 8mm mJ 3 5 3 6 2 3 7 3 8 3 9 3 10 4
45. 1 2 36 202 JIS T 0601 1 1 56 1i d JIS T 14971 9 JIS T 14971 0 Cm 2 JIS T 0601 1 1
46. 4 1 IEC 60601 1 IEC 60601 1 2 TEC 60825 1 JIS T 0601 1 JIS T 0601 1 2 JIS C 6802 4 2 IEC 60601 1 IEC 60601 1 2 4 3 4 3 1 IEC 60825 1 8 2 4 3 2 IEC 60825 1 4 2 4 3 3 TEC 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 IEC 60825 1 5 1 5 6 JIS C 6802 5 1 5 6 4 3 10 IEC 60601 2 22 6 1 bb
47. JIS T 0601 1 2 1 2 JIS T 7316 TEC 60601 1 Medicat electrical equtpment Part 1 Genera requirements for safety TEC 60601 1 2 Medical electrical equipment Part 1 2 General requirements for safety Coliateral standard Electromagnetic compatibiiity Requirements and tests IEC 60601 2 22 Medical electrical equipment Part 2 Particular requirements for the safety of diagnostic and therapeutic laser equipment TEC 60825 1 Safety of laser products Part 1 Equipment classification requtrements and user s guide 4 7 6 1 4 9 5 1 7 3 1 0 0310003 3 JIS T 0601 1 JIS T 0601 1 2 JISC 6802 3 1 3 2
Download Pdf Manuals
Related Search