薬事法 (昭末口35飼去軸ー45号。 以下 「法」 という。 ) 第ー4条第ー取は
Contents
1. 22. JIS 16 169 JIS T 14971 JIS T 0601 1 1
3. 4
4. 9 JIS T 14971 17 3 10 0310003 JIS T 14971
5. 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
6. 1 4 4 4 5 17 3 10 0310003 JIS T 14971 16
7. 1 5 2 3
8. 1 2 IEC 60601 2 22 Medica1 electrical equipment Part 2 Particular requirements for the safety of diagnostic and therapeutic laser equipment 49 nterruption of the power supply 52 Abnormal operation and fau1t condition
9. 5 6
10. 16 169 16 169 JIS T 14971 16 169 JIS T 14971 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
11. 4 5 6
12. JIS T 0601 1 1 43 1 2 3
13. 2 3 4 5 1
14. 6 7 8
15. JIS T 0601 1 1 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 held and foot operated contro1 devices JIS T 14971 1 JIS T 0601 1 1 10 2 2 IE
16. 11 2 1 4 4 2 JIS T 14971
17. 2 17 2 16 0216002
18. 2 NN 3 YY OE NN 9 6 2 1 4 1 1 9 2 1 1 7 2 16 0216002
19. J cm 4 6 6 1ns 10ns 50 20 4 6 7 3Hz 4 6 8 20 100 mn 50
20. 4 2 1 7 3 3 1 0331012 7 2 5 7 1 6 2 9 8 1 9 2 0 1 8 3 3 1 1 2
21. 1 4 4 2 _ 3 4 5
22. 8mm mJ 3 5 3 6 3 7 OE NE EN DOE RR OR 3 8 3 9 3 10 4 4 1 IEC 60601 1 IEC 60601 1 2 IEC 60825 1 JIS T 0601 1 JIS T 0601 1 2 JIS C 6802 4 2
23. 8 JIS T 0601 1 1 56 11 d
24. 7 TEC 60601 2 22 Medical electrical equipment Part 2 Particular requ1rements 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 genera1 assembly 57 MAINS parts components and layout 13 JIS T 0601 1 1 21 22 23
25. 4 5 4 6 1 2 1 7 3 1 0 0310003 3 IBC 60601 2 22 6 8 IEC60601 1 2 6 8 RE IEC 60825 1 6 1 0 4 7 6 1 4 95 4 6 1 IEC 60601 1 4
26. JIS T 14971 2 3 4 5 6
27. JIS T 14971 _ 2 3
28. JIS T 14971 JIS T 0601 1 1 25 42 43 57 57 10 59 2 IEC 60601 2 22 Medical electrical equipment Part 2 Particular requirements for th
29. 8 9 10 i a
30. 4 1 1 2 3 4 5 Hz V 6 A VA W 7 I T1EC 60601 2 22 6 4 4 2 1 TEC 60601 2 22 6 4 4 1 2 IEC 60601 2 22 6 1 20 1
31. 3 5 6 7 _
32. 7 1 JIS T 14971 3 2 4
33. 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 Collatera standard Electromagnetic compatibility Requirements and tests IEC 60601 2 22 Medica electrica1 equipment Part 2 Particular requ1rements 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 3 JIS T 0601 1 JIS T 0601 1 2 JIS C 6802 3 PK 2 3 2 3 3 3 4
34. 4 6 12 7 JIS T 14971 JIS T 0601 1 1 43 JIS T 14971
35. 4 6 12 1 4 6 13 2 1
36. 5 14 JIS T 0601 1 1 56 3 a JIS T 0601 1 1 42 TEC 60601 2 22 Medica1 eltectrical equipment Part 2 Parti
37. 4 6 9 _ 20 100m 50 4 6 10 JIS T 7316 4 6 11 50 1 5
38. 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 5 6 1 1 4 3 15 IEC 60601 2 22 3 2 f 59 1 0 1 4 3 16 4 3 17 1 Sa 2 4 4 4
39. IEC 60601 1 IEC 60601 1 2 4 3 4 3 1 TEC 60825 1 8 2 4 3 2 TEC 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 JISC 6802 5 1 5 6 4 3 10 IEC 60601 2 22 6 1 bb JIS C 6802 5 7 4 3 11 IEC 60825 1 5 8 5 1 1 JIS C 6802 5 8 5 1 1
40. 0331014 1 8 3 31 Ee 28 Aa HB HH 1 gt 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
41. 24 25 28 2 3 4
42. 1 3 4 2 5 1 1 2 JIS C 6802 JIS T 0601 1 1 JIS T 0601 1 2 1 2
43. 6 2 _4 6 3 4 6 4 1064nm 20mJ 1 mJ 209 2 509 100 1 20 3 5 1 20 4 6 5
44. C 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 2 36 202 JIS T 0601 1 1 56 11 d JIS T 14971
45. cular requirements for the safety of diagnostic and therapeutic laser equipment 50 Accuracy of operating data TEC 60601 2 22 Medical electrical equipment Part 2 Particular requirements for the safety of diagnostic and therapeutic 1aser equipment 51 Protection against hazardous output 2 3 52 Abnormal operation and fault condition 1 4 4 2 1
46. e 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 JIS T 0601 1 1 6 8 2 j 3 10 JIS T 14971
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