薬食発第0331014号
Contents
1.2. 5 NSK 9 6 EAR
3. ad Ao 15 _ 2 3 RT
4. JIS T 14971 yi 2 rR i 0 Peer res mr MP 4 A a Pf 5
5. y OO 1 2 TEC 60601 2 Medical e1ectrical equipment Part A 2 Particular requirements for the safety of diagnostic and therapeutic laser equipment 49 Interruption of the power supply 52 Abnormal operation and fault condition
6. 2 _ 3 _ 4 5 6 7 8
7. 3 16 169 4
8. BE 4 5
9. 1 JIS T 14971 _ _
10. 7 0 13 14 15 16 17 18 20 58 59 IEC 60601 2 22 Medica1 electrical equipment Part 2 Particular Tequ1rements for the safety of _ diagnostic and therapeutic aser equipment 19 Continuous LEAKAGE CURRENTS and PATIENT AUXILIARY CURRENTS 52 Abnormal operation and fault condition 56 Components and general assembly 57 MAINS parts components a and layout 13
11. 3 5 a a ee 16 169 JIS T 14971 16 169 JIS T 14971
12. JIS T 0601 1 1 10 2 2 TEC 60601 2 22 Medica electrical equipment Part 2 Particular requirements for the safety of diagnostic and therapeutic Iaser equipment 49 Tnterruption of the power supply JTS T 0601 1 2 1 2 36 202 JIS T 0601 1 1 56 11 d
13. 2 IS T 0601 1 2 1 JIS 7
14. 4 a 2 5 A OE 1 1 2 JIS C 6802 a JIS T 0601 1 1 os JTS 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 eleetrica
15. 4 6 13 2 _ 1 16 169 JIS T 14971
16. 6 a erxko 5 JIS T 0601 1 2 1 2 3 36 201 JIS T 0601 1 2 1 2 2 3 36 202 _ JIS T 0601 1 1 7
17. TIS T 14971 JIS T 14971 Oo 2 JIS T 0601 1 1
18. TIS T 14971 6 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
19. 10 3 2 RA OE
20. 8 9 10 rr 7 13
21. fee JIS T 14971 17 3 10 0310003
22. 4 1 4 4 2 1 JIS T 14971 1 4 4 2 1 5 11
23. JIS T 0601 1 1 56 11 d JIS T 14971 J 8
24. J 2 3 2 4 _ _
25. i 3 8 3 9 3 10 4 4 1 IEC 60601 1 TEC 60601 1 2 TIEC 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 a IEC 60825 1 8 2 4 3 2
26. 9 JIS T 14971 JIS T 0601 1 1 10 2 2 21 22 23 24 125 IEC 60601 2 22 Medica 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 dev1CeS JIS T 14971
27. Aa wv i 0 2 17 2 16 0216002 2 1
28. SE a x
29. JIS T 0601 1 1 56 3 a 5 Frame JIS T 0601 1 1 42 a lt IEC 60601 2 22 Medica1 electrical equipment Part
30. JIS T 0601 1 1 43 1 2 3 ir 6
31. 7 a JIS T 14971 JIS T 0601 1 1 43 _ JIS T 14971
32. 285 2 MTP FSRT 2 LC OMSORN EET 1 oemgiingie mitch gy ea J 2 A 4 4 4 4 1 1 2 3 4 5 Hz
33. nJ 209 50 100 20 a a J 3 5 1 20 4 6 5 Wen J em 4 6 6 1ns 10ns 50
34. TEC 60601 2 22 6 8 IEC60601 1 2 6 8 2011 0 4 TBC 60825 1 6 1 0 4 7 6 1 4 9 5 4 6 4 6 1 IEC 60601 1 4 6 2 _ _ 4 6 3 _ BI 450 700nm 4 6 4 J 1 532nm 3mJ 1 1064nm 20mJ 1
35. lt 4 v At 8 1 7 3 3 1 0331012 99 2 5 7 1 6 2 9 8 1 9 2 0 1 8 3 3 1 2 1 3
36. EE fe 1 4 4 4 5 17 3 10 0310003 TIS T 14971
37. 2 Particular reguirements for the safety of diagnostic and therapeutic laser equipment 50 Accuracy of operating _ data IEBC 60601 2 22 Medica1 electrical equipment Part 2 2 Particular reguirements for the safety of diagnostic and therapeutic laser equipment 51 Protection against hazardous output 52 Abnormal operation and fault condition 3 4 4 2 1
38. VA W 7 T IEC 60601 2 22 6 4 4 2 1 IEC 60601 2 22 6 4 4 1 2 IEC 60601 2 22 6 1 201 _ 4 5 RE J 1 1 7 3 1 0 0310003 3
39. _ 209 4 6 7 3Hz 4 6 8 20 100 nm 50 4 6 9 1 RE RRR RA lt a 20 100gnm _ 50
40. 0331014 1 8 3 31 3 5 1 4 5 1 4 1 1 9 2 1 7 1 4 9 1 9 2 5 ie DN 1 VD 1 1 7 2 16 0216002 CE Eesti
41. A iO JIS T 7316 4 6 11 50 1 5 MS _ 4 6 12 1 _
42. JIS T 0601 1 1 21 22 23 24 25 28 EGR _ _ 1 4 _ 3 868 _ 4
43. IEC 60825 1 4 2 4 3 3 2 TBC 60825 1 4 3 4 3 4 IEC 60825 1 4 4 3 5 IEC 60601 2 22 4 9 2 3 6 IEC 60825 1 4 5 83 7 _ HEC 60601 2 22 3 2 d e 3 8 IEC 60825 1 4 7 3 9 TBC 60825 1 5 1 5 6 JIS C 6802 5 5 6 4 4 3 10 TBC 60601 2 22 6 1 bb JIS C 6802 7 3 1 1 IEC 60825 1 5 8 5 1 1 lt JISC 6802 5 8 5 1 1 4 3 12 TEC 60601 2 22 5 1 1 0 1 3 TEC 60601 2 22 5 6 1 0 1 3 14 IEC 60601 2 22 5 6 1 1 3 15 TEC 60601 2 22 3 2 f 5 9 1 0 1 3 16 RM
44. 25 42 43 57 57 10 59 TEC 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 MATNS parts components and 1ayout TIS T 14971 rent JIS T 0601 1 1 8 Pace Eee 6 8 2 j JIS T 14971
45. 8 3 1 4 iW 9 6 2 1 4 1 1 9 2 1 0 17 2 1 6 0216002
46. l eqguipment Part 1 2 Genera1 requ1rements for safety Collatera standard Plectromagnet1c compatibility Requirements and tests TEC 60601 22 Medical electricalt equipment Part 2 Particular requirements for_ the safety of diagnost1c and therapeutic laser equipment IEC 60825 1 Safety of laser products Part 1 Equipment classification requirements and user s guide a 4 7 6 1 4 9 5 a 1 7 3 1 0 0310003 3 OO JIS T 0601 1 JIS T 0601 1 2 JIS C 6802 3 1 We 3 2 3 3 2 3 4 4 0 8mm 3 5 3 6 3 7
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