Page 1 Page 2 Page 3 薬事シ去第2条第5項から第?項までの規定によ
Contents
1. 3 42. 4
3. JIS T 0601 1 1 56 11 d JIS T 14971 8
4. 3 1 4 9 6 2 1 4 1 1 9 2 1
5. 4 5 6
6. 1 4 NN JIS T 0601 1 1 56 3 a 4 JIS T 0601 1 1 42 5 IEC 60601 2 22 Medica1 electrical equipment Part 2 Particular requirements for the safety of di
7. _ 2 3
8. 1 5 3
9. 8 EE 9 i DO 10 OR a a
10. TIS T 14971 17 3 10 0310003 9
11. 2 3 4
12. JIS T 14971 bb JIS T 0601 1 te 43 1 2 EE el Ea A
13. 2 16 17 2 16 0216002
14. 4 6 2 4 6 3 532nm 1064mm 450 700nm 4 6 4 532nm 3ml 1 1064nm 20mj 1 nmJ 20 2 509 100 1 20 ES 3 5
15. 16 169 2 16 169 4 JIS T 14971
16. 8mm nmJ 3 5 3 6 2 3 7 3 8 2 3 9 Ss 60 4 4 1 IEC 60601 1 IEC 60601 1 2 IEC 60825 1 JIS T 0601
17. JIS T 14971 CC 2 JIS T 0601 1 1 25 42 43 57 57 10 59 TEC 60601 2 22 Medical electrical equipment Part 2 Particular requirements for the safety of diagnostic
18. JIS T 14971 6 Rii JIS T 0601 1 1 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 control devices TIS T 14971 ON FE JIS T 0601 1 1
19. JIS T 14971 AE 2 3 4 5 tl
20. 6 7 AR 8 1 2 IEC 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 52 Abnormal operation and fault condition
21. 5
22. 2 TIS T 14971 JIS T 0601 1 1
23. 2 NNN 1 4 4 4 5 Po 17 3 10 0310003 JIS T 14971
24. 7 JIS 1 JIS T 14971 3
25. 4 4 4 4 1 1 2 3 4 5 Hz V 6 A VA W 7 IL TIEC 60601 2 22 6 4 4 2 1 IEC 60601 2 22 6 4 4 1
26. 5 16 169 TIS T 14971 TIS T 14971 6
27. 2 1 3 4 _ 2 5 1 2 JIS C 6802 JIS T 0601 1 1 JIS T 0601 1 2
28. a i 16 169 1
29. 1 20 4 6 5 J cm 4 6 6 1ns 10ns 50 20 4 6 7 3Hz 4 6 8
30. 2 IEC 60601 2 22 6 1 20 1 4 5 1 2 1 7 3 1 0 0310003 3 IEC 60601 2 22 6 8 TEC60601 1 2 6 8 201 4 IEC 60825 1 6 10 4 7 6 1 4 9 5 4 6 4 6 1 TIEC 60601 1
31. 10 2 2 IEC 60601 2 22 Medical electrical equipment Part 2 Particular requ1rements for the safety of diagnostic and therapeutic laser equipment 49 Tnterruption of the power supply TIS T 0601 1 2 1 2 36 202 JIS T 0601 1 EE 56 11 d NN
32. NIS 0 5 3 6 7
33. 1 5 MOE _ 4 6 12 1 4 6 13 2
34. 20 100 m 50 4 6 9 20 100 nm 50 4 6 10 JIS T 7316 4 6 11 50
35. 1 7 2 1 6 0216002 4 2 1 7 3 3 1 09331012 2 5 7 1 6 2 9 8 1 9 2 0 1 8 3 3 1
36. 0331014 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
37. 1 6 3 6 4 6 5 6 6 6 7 8 6 9 6 10 11 12 7 TIS T 14971 JIS T 0601 1 1 43
38. 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 Collatera standard Electromagnetic compatib1 1ty Requirements and testS IEC 60601 2 22 Medica electrical equ1pment Part 2 Particular requirements for the safety of diagnostic and therapeutic laser equipment IEC 60825 1 Safety of laser products Part 1 Equipment classificat1on requirements and user S gu1de 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 8 1 DNR CA OE 2 3 2 2 3 3 3 4
39. Ot 1 4 4 2 1 JIS T 14971 1 4 4 2 1 5 11 2
40. 13 5 16 17 18 20 58 59 Nr A IEC 60601 2 22 Medical electrical eqguipment Part 2 Particular requ1rements for the safety of diagnostic and therapeutic aser equ1pment 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 21 22 23
41. 24 25 28 2 3
42. 5 1 1 JISC 6802 5 8 5 1 1 4 3 12 IEC 60601 2 22 5 1 1 0 1 4 8 1 TEC 60601 2 22 56 10 1 4 3 14 IEC 60601 2 22 56 1 1 4 3 15 IEC 60601 2 22 3 2 f 59 1 0 1 4 3 16 3 1 7 1 Re 2
43. and therapeutic laser equipment 52 Abnormal operation and fault condition 56 Components and general assembly 57 MAINS parts components and layout TIS T 14971 JIS T 0601 1 1 6 8 2 3 2 JIS T 14971 10
44. 1 JIS T 0601 1 2 JIS C 6802 4 2 IEC 60601 1 TIEC 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 NL IEC 60825 1 4 4 35 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 TEC 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 3 4 3 1 1 IEC 60825 1 5 8
45. A RN 1 2 36 201 6 i T 0601 1 2 1 2 36 202 7 JIS T 0601 1 1 7
46. agnostic and therapeut1ic 1aser equipment 50 Accuracy of operating data TEC 60601 2 22 Medica1 electrical equipment Part 2 Particular requlrements for the safety of diagnostic and therapeutic laser equipment 51 Protection against hazardous output 52 Abnormal operation and fault condition 3 2 1 4 4 2 1
Download Pdf Manuals
Related Search