通知本文はこちら（PDF） - 一般財団法人日本薬事法務学会
Contents
1.2.
3.
4. 14 2
5. 3 JIS
6. 2 2
7. 8
8. 1 21 22 23 24 25 28 JIS T 0601 1 1 56 3 a JIS T 14971 JIS T 0601 1 1 42 JIS T 14971 IEC 60601 2 22 Medical electrical equipment Part 2 Particular requirem
9. 1 1 4 4 4 5 17 3 10 0310003 UIS T 14971 _ 16 j 17 2 16
10. WW 13 UIS T 0601 1 tt 36 201 JIS T 0601 1 2 1 LS 2 36 202 JIS T 0601 1
11. 1 4 4 2 1 UIS T 14971 1 4 4 2 1 4
12. 9 2
13. 5 6 169
14. E JIS T 14971 JIS T 0601 1 1 25 42 43 57 57 10 59 IEC 60601 2 22 Medical electrical equip
15. 11
16. 16 169 JIS T 14971 JIS T 0601 1 1 7 1 JIS T 14971 4
17. 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 0331018 1 4 4 JIS T 14971 5
18. 18 3 31 0331018 1 4 4 JIS T 14971 JIS T 0601 1 1 56 11 d JIS T 14971 16 169 CO
19. 1 1 2 1 3 4 6 11
20. Medical electrical equipment Part 2 Particular requirements therapeutic laser equipment 49 Interruption of the power supply 52 Abnormal operation and fault condition JIS T 14971 g
21. 15 2 3
22. oO
23. Bi 16 169 JIS T 14971 16 169 JIS T 14971 JIS T 14971 1 6 3 6 4 6 5 6 6 6 7 6 8 6 9 6 10 6 11
24. 4 6 4 4 6 5 4 6 7 4 6 10 4 6 12 4 7 17 3 31 0331018 2 1
25. 2 17 3 31 0331012 gt 2 5 7 16 298 1 919 18 3 31 1 2 1 3
26. pg 0 2 3 10 90
27. NN 32282 4 2 o 5 O 18 3 31 0331017 IVD ER 1 1
28. 2 JIS C 6802 JIS T 0601 1 IT JIS 0601 1 1 1 1 JIS T 0601 1 2 1 2 JIS T 7306 JIS T 7316 IEC 60601 1 Medical electrical equipment Part 1 General reguirements for safety IEC 60601 1 1 Medical electrical equipment Part 1 1 General reqguirements for safety Collateral standard Safety requirements for medical electrical systems IEC 60601 1 2 Medical electrical equipment Part 1 2 General requirements for safety Collateral standard Electromagnetic compatibility Requirements and tests IEC 60601 2 22 Medical electrical eqguipment Part 2 Particular requirements for the safety of diagnostic and therapeutic laser equipment IEC 60825 1 Safety of laser products Part 1 Equipment classification requirements and user Ss gulde 47 6 1 495
29. 3 14 96 2 14 1 19 2 1 aa NA 17 2 16 0216002
30. 17 3 10 0310003 18 3 31 0331018 3 JIS T 0601 1 JIS T 0601 1 2 JIS C 6802 3 1 3 2 3 3 8mm W RN 3 4 3 5
31. 10 2 2 Rt 4 ee fi Or IEC 60601 2 22 Medical electrical equipment Part 2 Particular requirements therapeutic laser eduipment 49 Interruption of the DOWer supply JIS T O0601 1 2 1 2 36 202 UIS T 0601 1 1 56 11 d UIS T 14971
32. 12 3 Hl
33. 16 169 JIS T 14971 17 3 10 0310003 JIS T 14971 17 3 10 0310003 JIS T 0601 1 1 JIS T 14971 JIS T 0601 1 1 10 2 2 24 25 IEC 60601 2 22 Medical electrical equipment Part 2 Particular requirements for the safety of diagnostic and therapeutic laser eduipment 56 11 Cord connected hand held and foot operated control devices UIS T 14971 UIS T 0601 1 1
34. 5
35. 6 7 13 5 20 100 gm 50 FE 4 6 8 4 6 9 50 1 5 4 6 10
36. 7 JIS T 14971 2 8
37. 3 6 3 7 4 4 1 IEC 60601 1 IEC 60601 1 1 IEC 60601 1 2 IEC 60825 JIS T 0601 1 JIS T 0601 1 1 JIS T 0601 1 2 JIS C 6802 4 2 1 IEC 60601 1 IEC 60601 1 2 BF 4 2 2 IEC 60601
38. 18 3 31 0331018 1 4 5 18 3 31 0331018 1 4 5 169 5 9 10
39. 4 4 1 1 2 4 5 Hz V 6 A VA W 7 I IEC 60601 2 22 6 4 4 2 1 IEC 60601 2 22 6 4 4 1
40. 1 7 16 17 18 20 58 59 IEC 60601 2 22 Medical electrical equipment Part 2 Particular ruquirements 13 14 15 therapeutic laser edquipment 19 Continuous LEAKAGE CURRENTS and PATIENT AUXILIARY CURRENTS 52 Abnormal operation and fault condition 56 Components and general assembly 57 MAINS parts components and ayout 2
41. 2 IEC 60601 1 2 6 1 201 4 5 1 2 17 3 10 0310003 3 IEC 60601 2 22 6 8 IEC 60601 1 2 6 8 201 4 IEC 60825 1 6 10 47 6 1 495 4 6 4 6 1 IEC 60601 1
42. 0216002 2 1 2 1
43. oO 4 6 2 CW 4 6 3 488nm 514nm 521nm 531nm 532nm 561nm 568nm 575 680nm 788 828nm 4 6 4 1 2 1 W 20 2 W J 20 3
44. 1000mW 1000mW 0 2 500 500 1 2 20 4 6 5 W cm lt 4 6 6 50 10 0 1 509 6 50 10 6 0 1 50
45. 1 1 3 4 3 1 IEC 60825 1 8 2 4 3 2 IEC 60825 1 4 2 3 3 IEC 60825 1 4 3 4 3 4 IEC 60825 1 4 4 4 3 5 IEC 60601 2 22 49 2 4 3 6 IEC 60825 1 4 5 4 3 7 IEC 60601 2 22 32 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 3 10 IEC 60601 2 22 6 1 bb JIS C 6802 5 7 4 3 11 IEC 60825 1 5 8 5 11 JIS C 6802 5 8
46. 5 11 3 12 IEC 60601 2 22 51 101 4 3 13 IEC 60601 2 22 56 101 3 14 IEC 60601 2 22 56 11 4 3 15 IEC 60601 2 22 32 f 59 101 3 16 4 3 17 1 2
47. O 18 3 31 0331016 35 145 14 1 19 2 1 14 9 19 2 5 IVD 1 17 2 16 0216002
48. ents therapeutic laser equipment 50 Accuracy of operating data E6 60601 2 22 Medical electrical equipment Part 2 Particular requirements therapeutic laser eduipment 51 Protection against hazardous outbput 52 Abnormal operation and fault condition 1 4 4 2 1 Ri 3
49. ment Part 2 Particular requirements therapeutic laser eduipment 52 Abnormal operation and fault condition 56 Components and general assembly 57 MAINS parts components and layout JIS T 14971 JIS T 0601 1 1 j JIS T 14971
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