薬食発第033ー0ー6号
Contents
1. 16 169 16 169 JIS T 14971 16 169 JIS T 149712. JIS T 14971 JIS T 0601 1 1 43 18 3 31 0331018 1 4 4 18 3 31 0331018 1 4 4
3. 6
4. 5 6
5. 2 4 4 4 4 1 1 2 3 4 5 Hz V 6 A VA WW 7
6. 2 2
7. 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 a 8
8. 9 16 169 10
9. 16 169 2
10. IEC 60601 2 22 Medical electrica equipment Part 2 Particular requirements for the safety of diagnostic and therapeutic aser equipment 49 Interruption of the power supply 52 Abnormal operation and fault condition JIS T 14971 _ 3 4
11. 4 5 6
12. 4 6 7
13. JIS JIS T 14971 JIS T 0601 1 1 7 1 JIS T 14971 3
14. JIS T 14971 17 3 10 0310003 JIS T 14971
15. 2 16 169
16. 1 7 3 3 1 0331018 2 1 3
17. 3 4
18. 8 1 2 2
19. 42 JIS T 14971 TEC 60601 2 22 Medica1 electrica equtpment Part 2 Particular requlrements for the safety of diagnostic and therapeutic laser equipment 50 Accuracy of operating data TEC 60601 2 22 Medica1 electrical equipment Part 2 Particular requirements for the safety of diagnostic and therapeutic laser equipment 51 Protection against hazardous output 52 Abnormal operation and fau t condition 1 4 4 2 1
20. 1 3 4 6 11 4 6 4 4 6 5 4 6 7 4 6 1 0 4 6 12 4 7
21. 6 8 2 j JIS T 14971 10 2 _
22. 4 4 2 1 JIS T 14971 2 3
23. 10 2 2 21 22 23 24 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 contro1 devices JIS T 14971 JIS T 0601 1 1 10 2 2 EC 60601 2 22 Medical electrical equipment Part 2 Particu lar requirements for the safety of diagnostic and therapeutic laser equipment 49 Tnterruption of the power supply JIS T 0601 1 2 1
24. 2 3 1 4 6 2 1 4 1 1 9 2 1 1 7 2 1 6 02160
25. 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 IEC 60601 2 22 Medical electrical equ1pment Part 2 Particular TequirTements for the safety of diagnostic and therapeutic laser equipment 19 Continuous LEAKAGE CURRENTS and PATIENT AUXILIARY CURRENTS 52 Abnormal operation and fault condition 56 Components and genera assemb y 57 MAINS parts components and layout i 13T 60T Ni JIS T 0601 1
26. W 20 2 W J 20 3 1000mW 1000mW 0 2 er 500 1 20 4 6 5 W cm 4 6 6 50 10 0 1
27. 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 2
28. 17 3 10 0310003 JIS T 0601 1 1 1 1 9 JIS T 14971 JIS T 0601 1 1
29. 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 TEC 60601 2 22 Medica1 electrical equipment Part 2 Particular requirements for the safety of diagnostic and therapeut1c laser equ1pment 52 Abnormal1 operation and fault condition 56 Components and general aSsembly 57 MAINS parts components and layout JIS T 14971 3 JIS T 0601 1 1
30. 5 6 7
31. 18 3 31 0331018 1 4 5 7 18 3 31 0331018 1 4 5 8
32. 2 JIS T 7306 JIS T 7316 TEC 60601 1 Medica electrica equipment Part 1 General requirements for safety TEC 60601 1 1 Medica1 electrica l equipment Part 1 1 General requirements for safety Collateral standard Safety requirements for medica electrica systems IEC 60601 1 2 Medical electrica equipment Part 1 2 General requirements for safety Collateral standard Electromagnetic compatibility Requirements and tests TEC 60601 2 22 Medica electrica equipment Part 2 Particular requirements for the safety of diagnostic and therapeutic laser equipment TEC 60825 Safety of aser 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
33. 2 1 4 4 4 5 17 3 10 0310003 JIS T 14971 17 2 16 0216002 2 1
34. 3 4 1 5 1 4 4 2 1 1 1
35. JTS T 7306 4 6 9 50 1 5 4 6 10 1 1 2
36. 2 3 e 1 5 JIS T 0601 1 1
37. ES 21 22 23 24 25 2 3
38. 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 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
39. 3 1 3 2 3 3 8mm W mW 3 4 3 5 3 6 6 3 7
40. 4 JIS T 0601 1 1 56 3 a JIS T 14971 5 1 4
41. 50 50 10 _ 0 1 50 4 6 7 13 5 20 100m 50 4 6 8 lt 3 JIS T 7316
42. 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 1 VD 1 1 7 2 1 6 0216002
43. 2 3 1 6
44. H IEC 60601 2 22 6 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
45. 2 1 3 4 2 5 1 1 2 JIS C 6802 JIS T 0601 1 a a 1 JIS T 0601 1 1 1 1 i SE JIS T 0601 1 2 1
46. 8 20 1 4 1IEC 60825 1 6 1 0 4 7 6 1 4 9 8 4 6 4 6 1 IEC 60601 1 3 4 6 2 CW 4 6 3 568nm 575 680nm 788 828nm 450 700nm 4 6 4 1 2 0 pp 1
47. JIS T 14971 JIS T 0601 1 1 43 1 18 3 31 0331018 1 3 4
48. 02 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
49. 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 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 5 1 1 0 1 4 3 13 IEC 60601 2 22 56 101 4 3 14 TEC 60601 2 22 5 6 1 1 4 3 15 IEC 60601 2 22 3 2 f 5 9 1 0 1 4 3 16 3 1 7
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