自良末斗用 レデザ光凝固装闘認基準の制定について 薬朝去 (昭和35蜩
Contents
1. JIS2. 16 169 lo 4
3. 5 6
4. 16 169 16 169 JIS T 14971 16 169 JIS T 14971 JIS T 14971 1 4 6 3 4 6 4
5. 4 5 6
6. 5 6
7. 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 1 43 1 18 3 31
8. IEC 60601 2 22 Medica1 electrical equipment Part 2 Particular requirements for the safety of diagnostic and therapeutic 1aser equipment 49 Interruption of the power SupDly 52 Abnormal operation and fault condition JIS T 14971 2 3
9. JIS T 0601 1 2 1 2 36 201 JIS T 0601 1 2 1 2 36 202 JIS T 0601 1 1 7 13 14 15 16 17 18 20 58 59 TEC 60601 2 22 Medica1 electrical eqguipment Part 2 Particular requirements for the safety of diagnostic and therapeutic laser equipment 19 Continuous LEAKAGE CURRENTS and PATIENT AUXILIARY CURRENTS 52 Abnormal operation and
10. 4 6 11 4 6 4 4 6 5 4 6 7 4 6 1 0 4 6 12 4 7 1 7 3 3 1 0331018 2
11. 4 JIS T 0601 1 1 56 3 a JIs T 14971 5
12. 2 4 4 4 4 1 1 2 3 4 5 Hz V 6 A VA W 7 H IEC 60601 2 22 6
13. 9 10
14. 2 2 36 202 JIS T 0601 1
15. 16 169 JIS T 14971 17 3 10 0310003 JIS T 14971 17 3 10 0310003 JIS T 0601 1 1 1 1 JIS T 14971 JIS T 0601 1 1 10 2 2 21 22 23 24
16. 3 1 4 0Lo 478 4 9 6 2 1 4 1 1 9 2 1 1 7 2 1 6 0216002 4
17. _ 2 3
18. 4 j 3 1 1 4 4 2 1 JIS T 14971 1 1 4 4 2 1 5
19. 9
20. 1 1 2 3
21. 50 lt ee 2 NL RRO 4 6 10 1 1 2 1 3
22. 4 4 2 1 IEC 60601 2 22 6 4 4 1 2 IEC 60601 1 2 6 1 20 1 4 5 1 2 1 7 3 1 0 0310003 3 TIEC 60601 2 22 6 8 IEC60601 1 2 6 8 20 1 4 IEC 60825 1
23. 3 3 8mm W mW 3 4 3 5 3 6 3 7 4 4 1 TIEC 60601 1 IEC 60601 1 1 IEC 60601 1 2 TEC 60825 1 JIS T 0601 1 JIS T 0601 1 1 JIS T 0601 1 2 JIS C 6802 4 2
24. 7 8 1 2
25. JIS T 14971 6 ER JIS T 0601 1 1 56 11 d JIS T 14971 8
26. 50 10 0 1 50 amp 4 6 7 13 5 20 100m 50 _ 4 6 8 JTIS T 7316 JIST 7306 4 6 9
27. EB 5 1 2
28. 1 4 2 3
29. 4 4 4 5 17 3 10 0310003 JIS T 14971 16 17 2 16 0216002 2 1 2
30. 2 1 7 3 3 1 033102 2 5 7 RN CR RN I 1 9 1 9 1 8 3 3 1 1 2 1 3 4
31. 4 2 1 TEC 60601 1 IEC 60601 1 2 BF 4 2 2 IEC 60601 1 1 4 3 4 3 1 IEC 60825 1 8 2 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 TEC 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
32. 4 _ 1 5 18 3 31 0331018 1 4 4
33. _
34. 16 169 JIS T 14971 JIS T 0601 1 1 7 1 JIS T 14971 3 4
35. 6 8 2 j JIS T 14971 10 2
36. 7 8 18 3 31 0331018 1 4 5 18 3 31 0331018 1 4 5
37. 0331016 1 8 3 31 WA HH 2 1 aN 1 9 2 5 1 VD 1 1 7 2 1 6 0216002 i E
38. 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 Medical electrical equipment Part 2 Particular requirements for the safety of diagnostic and therapeutic laser equipment 52 Abnormal operation and fault condition 56 Components and general assembly 57 MAINS parts components and layout JIS T 14971 3 JIS T 0601 1 1
39. 0331018 1 4 4 JIS T 14971 3 _
40. 2 5 1 1 2 JIS C 6802 JIS T 0601 1 1 JIS T 0601 1 1 1 1 JIS T 0601 1 2 1 2 JIS T 7306 JIS T 7316 TEC 60601 1 Medical electrical equipment Part 1 General requirements for safety TEC 60601 1 1 Medica electrical1 equipme
41. 1 5 JIS T 0601 1 1 42 JIS T 14971 IEC 60601 2 22 Medical electrical equipment Part 2 Particular requ1rements for the safety of diagnostic and therapeutic laser equipment 50 Accuracy of operating data TEC 60601 2 22 Medicat electrical equipment Part 2 Particular requirements for the safety of diagnostic and therapeutic laser equipment 51 Protection against hazardous output 52 Abnor
42. 25 IEC 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 control devices j JIS 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
43. 30 W 20 a 3 1000mW 1000mW 0 2 500 500 1 2 20 4 6 5 W cm 4 6 6 50 10 0 1 50
44. 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 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 TEC 60601 2 22 3 2 f 59 1 0 1 4 3 16 4 3 17 1
45. fault condition 56 Components and general assembly 57 MAINS parts components and ayout 1 3 JIS T 0601 1 1 21 22 23 24 25 2 3
46. 4 5 6 7
47. 4 6 5 4 6 6 4 6 7 4 6 8 4 6 9 4 6 10 4 6 11 7 2
48. 6 1 0 4 7 6 1 4 9 5 4 6 4 6 1 IEC 60601 1 4 6 2 CWO 4 6 3 488nm 514nm 521nm 531nm 532nm 561nm 568nm 575680nm 788 828nm 4 6 4 1 2 1 W 20
49. mal operation and fault condition 1 4 4 2 1 2 3 1
50. nt Part 1 1 Genera requirements for safety Collateral standard Safety requirements for medical electrica1 SYStems TEC 60601 1 2 Medica electrical equipment Part 1 2 General requ1rements for safety Collateral standard Electromagnetic compatibility Requirements and tests TEC 60601 2 22 Medica electrica equipment Part 2 Particular requ1rements for the safety of diagnostic and therapeut1c laser equ1pment IEC 60825 1 Safety of 1aser 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 JIS T 0601 1 JIS T 0601 1 2 JIS C 6802 3 1 3 2
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