百長兼斗用 レーザ光凝固装闘認離の制定について 薬事法 (日召末ロ3 5
Contents
1. 2 36 202 JIS T 0601 1 12. 1 4 4 4 5 17 3 10 0310003 JIS T 14971 17 2 16 0216002 2 1
3. 16 169 16 169 JIS T 14971 16 169 JIS T 14971
4. 6
5. 1 2
6. JIS T 14971 JIS T 0601 1 1 43 18 3 31 0331018 1 4 4 18 3 31 0331018 1 4 4 JIS T 14971 JIS T 0601 1
7. JIS T 0601 1 1 42 JIS T 14971 IEC 60601 2 22 Medica1 electrica equipment Part 2 Particular requlrements for the safety of diagnostic and therapeut1c 1aser equipment 50 Accuracy of operating data IEC 60601 2 22 Medica1 electrical equipment Part 2 Particular requirements for the safety of diagnostic and therapeutic laser equipment 51 Protection agaihst hazardous output 52 Abnormal operation and fault condition 1 4 4 2 1 2 3
8. 6
9. JIS T 14971 JIS T 0601 1 2 1 JIS 7
10. 3 4
11. 4 4 JIS T 14971 18 3 31 0331018 1 4 4 JIS T 14971 JIS T 0601 1 1 56 11 d JIS T 14971 8
12. 4 5 6
13. 4 WW 5 7
14. 16 169 2
15. 2 4 4 4 4 4 1 1 2 3 4 5 Hz V 7 I 082 22 6
16. 50 1 5 4 6 10 1 1 2
17. 3 3 8mm W mW 3 4 3 3 3 6 3 7 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
18. 5 6 7
19. 1 JIS T 14971 3
20. JIS T 0601 1 2 1 2 36 201 JIS T 0601 1 2 1 2 36 202 JIS T 0601 1 1 13 14 15 16 17 18 20 58 59 TEC 60601 2 22 Medica1 electrical equipment Part 2 Particular requirements for the safety of diagnostic and therapeutic aser equipment 19 Continuous LEAKAGE CURRENTS and PATIENT AUXTLTARY CURRENTS 52 Abnormal operation and fault condition S6 Components and general assembly 57 MAINS parts components and layout 0 EE EEE ET ET EF
21. 17 3 10 0310003 JIS T 14971 17 3 10 0310003
22. JIS T 0601 1 1 1 1 9 IS T 14971 JIS T 0601 1 1 10 2 2 21 22 23 24 25 TEC 60601 2 22 Medica1 electrica e
23. 4 NN ds 1 a 56 3 a TIS T 4971 5 1 4
24. 50 10 0 1 50 4 6 7 13 5 20 100 nm 50 4 6 8 Ni ii g a A JIS T 7316 JIS T 7306 4 6 9
25. 4 2 5 1 1 2 TIS C 6802 JIS T 0601 1 i 1 JIS T 0601 1 1 1 1 Ro JIS T 0601 1 2 1 2 JIS T 7306 JIS T 7316 TEC 60601 1 Medical
26. 4 2 1 7 3 3 1 0331012 2 5 7 CR OO A NO 1 9 1 9 1 8 3 3 1 1 3 1
27. 2 RE PO 3 1 4 9 6 2 1 4 1 1 9 2 1 1 7 2 1 6 0216002
28. 6 8 NN IEC 60601 2 22 Medica1 electrical equipment Part 2 Particular requirements for the safety of diagnostic and therapeutic laser equtpment 49 Interruntion of the power supply 52 Abnormal operation and fau t condition 2 JIS T 14971 3
29. 1 1 2 3
30. 4 4 2 1 IEC 60601 2 22 6 4 4 1 2 IEC 60601 1 2 6 1 20 1 1 2 1 7 3 1 0 0310003 0 4 3 TIEC 60601 2 22 6 8 IEC60601 1 2 6 8 20 1 4 IEC 60825 1 6 1 0
31. JI1S 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 2
32. 7 8 ee 18 3 31 0331018
33. 3 E 4
34. 1 7 3 3 1 0331018 2 1 16 169
35. 2 3 1 5
36. JIS T 0601 1 FN 21 22 23 24 25 2 j 3
37. 2 1 6
38. 57 MAINS parts components and ayout JIS T 14971 JIS T 0601 1 1 6 8 2 j JIS T 14971 1 4 4 2 1 JIS T 14971 1 4 4 2 1 5
39. 1 43 1 18 3 31 0331018 1 3 4
40. 4 7 6 1 4 9 5 6 4 6 1 IEC 60601 1 6 2 CW 6 3 488nm 514nm 521nm 531nm 532nm 561nm 568nm 575 680nm 788 828nm 4 6 4 1 2 3W sy 4 3 15 1 W
41. 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 JIS C 6802 5 7 4 3 1 1 TEC 60825 1 5 8 5 1 1 JIS C 6802 5 8 5 1 1 4 3 12 IEC 60601 2 22 51 101 4 3 13 IEC 60601 2 22 56 101 4 3 14 IEC 60601 2 22 56 1 1 4 3 15 IEC 60601 2 22 3 2 f 59 1 0 1 4 3 16 4 3 17 1
42. 1 4 5 18 3 31 0331018 1 4 5 16 169 9 16 169 JIS T 14971 1 0
43. 0331016 1 8 3 3 1 1 EE 0 3 i ee 0 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
44. 20 2 W J 20 3 Ne 1000mW 1000mW 0 2 500 1 2 20 4 6 5 7cm 4 6 6 50 10 0 1 50
45. 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 condition 56 Components and genera assembly 3 10 2
46. JIS C 6802 4 2 4 2 1 OR IEC 60601 1 IEC 60601 1 2 4 2 2 IEC 60601 1 1 4 3 6 4 3 1 IEC 60825 1 8 2 8 4 3 2 IEC 60825 1 4 2 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
47. electrical equipment Part 1 Genera requ1rements for safety TEC 60601 1 1 Medica electrical equipment Part 1 1 General requ1rements for safety Collateral standard Safety requirements for medical electrica systems IEC 60601 1 2 Medica1 electrical equipment Part 1 2 Genera requirements for safety Collateral standard Electromagnetic compatibility Requirements and tests TEC 60601 2 22 Medica 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 requirements and user s guide 4 7 6 1 4 9 5 1 7 3 1 0 0310003 1 8 3 3 1 0331018 3 I 2 JIS T 0601 1 JIS T 0601 1 2 JIS C 6802 i BMN 3 1 3 2
48. 1 3 4 6 11 4 6 4 4 6 5 4 6 7 4 6 1 0 4 6 12 4 7
49. quipment Part 2 Particular requirements for the safety of diagnostic and therapeutic laser equipment 56 11 Cord connected hand held and foot operated control devices IS T 14971 JIS T 0601 1 1 10 2 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 JIS T 0601 1 2 1
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