薬事法 (昭和3 5培去輔ー 4 5号。 以下 「法」 という。 ) 第ー 4条第ー項
Contents
1. 1 4 4 4 5 17 3 10 0310003 JIS T 14971 16 lt2. JIS T 0601 1 2
3. to 10
4. 4 j 3 1 4 4 2 1 JIS T 14971
5. IEC 60601 2 22 Medica1 electrical equipment Part 2 Particular requirements for the safety of diagnostic and therapeutic 1aser equipment 51 Protection against hazardous output 52 Abnormal operation and fault condition 3
6. 3 4 5 6
7. 3 4 5
8. 5 16 169 JIS T 14971 TIS T 14971 6
9. 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 power supply of the JIS T 0601 1 2 1 2 36 202 JIS T 0601 1 1 56 11 d JIS T 14971 JIS T 14971
10. 3
11. 1 4 JIS T 0601 1 1 56 3 a JIS T 0601 1 1 42 IEC 60601 2 22 Medica1 electrical equipment Part 2 Particular requirements for the safety of diagnostic and therapeutic laser equipment 50 Accuracy of operating data 2
12. JIS 1 7 1 JIS T 14971
13. 7 8 NN
14. 20 100 mn 50 4 6 9 20 100 m 50 4 6 10 JIS T 7316 4 6 11
15. 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 4 6 12 7 JIS T 14971
16. 3 4 5 JIS T 0601 1 2 1
17. 6 JIS T 0601 1 1 56 11 d JIS T 14971
18. 8 2
19. JIS T 14971 17 3 10 0310003 9 JIS T 14971 JIS T 0601 1 1
20. 2 17 2 16 0216002 2 1
21. 3 4 5
22. 2 1 16 169 JIS T 14971
23. 50 1 5 4 6 12 1 4 6 13
24. 2 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 1aser equipment 52 Abnorma operation and fault condition 56 Components and general assembiy 57 MAINS parts components and layout 1 JIS T 14971
25. 5 1 4 4 2 1 1 1 2 1
26. 2 36 201 6 JIS T 0601 1 2 1 2 36 202 JIS T 0601 1 1 7 13 14 15
27. 1 2 TEC 60601 2 22 Medical electrical equipment Part 2 Particular requirements for the safety of diagnostic and therapeutic laser equipment 49 1nterruption of the power supply 52 Abnormal operation and fault condition JIS T 14971 2
28. 2 8 1 4 9 6 2 1 4 1 1 9 2 1
29. 3 16 169 4 16 169 JIS T 14971
30. 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
31. 1 4 4 2 1 1 5 2 3
32. 10 2 2 21 22 23 24 25 IEC 60601 2 22 Medical electrical equipment Part 2 Particular requ1rements for the safety of diagnostic and therapeutic laser equipment 56 11 Cord connected hand heid and foot operated control devices j
33. 3 3 3 4 8mm mJ 3 5 3 6 3 7 3 8 3 9 3 10 4 4 1
34. 1 2 1 3 4 2 5 1 1 2 JIS C 6802 JIS T 0601 1
35. 16 17 18 20 58 59 IEC 60601 2 22 Medica1 electrica equipment Part 2 Particular requirements for the safety of diagnostic and therapeutic 1aser equipment 19 Continuous LEAKAGE CURRENTS and PATIENT AUXILIARY CURRENTS 52 Abnormal operation and fault condition 56 Components and general assembly 57 MAINS parts components and layout 13 JIS T 0601 1 1 2 22 23 24 5 28 2
36. JIS T 0601 1 1 43 JIS T 14971 JIS T 0601 1 1 43 1 2
37. 6 7 8
38. A 1 GR 2 H 4 4 4 4 1 1 2 3 4 5 Hz V 6 A VA W 7 HI IEC 60601 2 22 6 4 4 2
39. 3 JIS T 0601 1 1 6 8 2 j JIS T 14971 1 0 I 2
40. 1 JIS T 0601 1 2 1 2 JIS T 7316 TEC 60601 1 Medical electrical equipment Part 1 General requirements for safety TEC 60601 1 2 Medical electrical equipment Part 1 2 General requirements for safety Collateral standard Electromagnetic compatibi1ity Requirements and tests IEC 60601 2 22 Medical electrical equipment Part 2 Particular requirements for the safety of diagnostic and therapeutic 1aser equipment IEC 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 3 JIS T 0601 1 JIS T 0601 1 2 JIS C 6802 3 1 3 2
41. 0331014 1 8 3 31 3 5 1 4 5 1 4 1 1 9 2 1 1 4 9 1 9 2 5 T VD 1 1 7 2 1 6 0216002
42. 3 5 1 20 4 6 5 J cm 4 6 6 1ns 10ns 50 20 4 6 7 3Hz 4 6 8
43. 1 IEC 60601 2 22 6 4 4 1 2 IEC 60601 2 22 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 6 1 0 47 6 1 4 95
44. 1EC 60601 1 1EC 60601 1 2 IEC 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 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 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
45. 4 NN 5
46. 4 6 4 6 1 IEC 60601 1 4 6 2 4 6 3 532mm 1064nm 450 700nm 4 6 4 532nm 3mm 1 1064nm 20mJ 1 mj 20 2 50 100 1 20
47. 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 5 6 1 0 1 4 3 14 IEC 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 4 3 17 1 Ss
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