薬食発第0331016号
Contents
1. 3 Rmm 1 4 9 6 2 1 4 1 1 9 2 1 EO AR RO FR ARN 1 7 2 1 6 02160022. 4 J 2 J 5 1 1 E 2 JIS C 6802 JIS T 0601 1 1 JIS T 0601 1 1 1 1 ee JIS T 0601 1 2 1 2
3. 1 _ NE 3 42 6 1 4 6 4 4 6 5 _ 4 6 7 4 6 1 0 4 6 12 1 6
4. 1 W 20 2 W 20 3 1000mW 1000mW 0 2 500 500 1 2 O 20 4 6 5 W cmf 4 6 6
5. TJIS T 7316 Cs JIST 7306 4 6 9 50 2 RI 1 5 NE 4 6 10 a 1 1 2
6. 1 _ 8 2 4 4 _ 4 4 1 1 2 3 4 5 Hz V 6 4 VA WW 7
7. J 1 7 3 chidingrorrserei
8. JIS T 7306 JIS T 7316 _IEC 60601 1 Medical electrical equipment Part 1 General requirements for safety IEC 60601 1 1 Medicai electrical equipment Part 1 1 General requirements for safety Collateral standard Safety reauirements for medical electrical systems IEC 60601 1 2 Medical electrical equipment Part 1 2 General requirements for safety Collateral standard Electromagnet1c compatibility Requ1rements and tests _ TEC 60601 2 22 Medica1 ic equipment Part 2 Particular requirements for the safety of diagnostic and therapeutic laser equ1pment TEC 60825 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 1 8 3 3 1 0331018 E 3 JIS T 0601 1 JIS T 0601 1 2 JTS C 6802 3 1
9. 2 3 2 6 ES i 3 3 we Sm W mW 8 4 3 5 3 6 9 Eee 4 4 1 TBEC 60601 1 IBC 60601 1 1 IEC 60601
10. IHI TIEC 60601 2 22 6 4 4 2 1 TBC 60601 2 22 6 4 4 2 IEC 60601 1 2 6 1 2011 4 5 _ 1 1 7 3 1 0 0310003 3 _ TIBEC 60601 2
11. 50 _ 10 0 1 50 50 10 0 1 50 4 6 7 J 13 5 20 100 gm 50 4 6 8
12. 0331016 1 8 3 3 1 E 3 5 1 4 5 1 4 1 1 9 Eee 1 9 2 5 1 VD 1 1 7 2 1 6 600 5 2
13. b amp b 4 2 1 7 3 3 1 uu 0331012 2 5 7 1 6 2 9 8 1 9 1 9 _ 1 8 3 3 1 1 2 1 3
14. 4 3 6 TEC 60825 1 4 5 4 3 7 TEC 60601 2 22 3 2 d e 4 3 8 TEC 60825 1 4 7 4 3 9 TBC 60825 1 5 1 5 6 JTS C 6802 5 1 5 6 4 3 10 IEC 60601 2 22 6 1 bb JIS C 6802 5 7 4 3 1 1 IEC 60825 1 5 8 5 1 1 JIS C 6802 5 8 5 1 1 4 3 12 _ TBC 60601 2 22 51 1 0 1 4 8 TBC 60601 2 22 56 1 0 1 4 3 14 IEC 60601 2 22 56 1 1 4 3 15 1B6 60601 2222 32 1 59 101 4 3 16 _ 4 3 17
15. 22 6 8 _ TEC60601 1 2 6 8 201 a 4 IEC 60825 1 6 1 0 4 7 6 1 4 9 5 4 6 a 4 6 1 IEC 60601 1 4 6 2 CW 4 6 3 488nm 514nm 521nm 531nm 532nm 561nn 568nm 575 680nm 788 828nm 450 700nm 1 _ 4 6 4 2
16. 1 2 TEC 60825 1 JIS T 0601 1 JIS T 0601 1 1 JTS T 0601 1 2 JIS C 6802 4 2 4 2 1 _ TIEC 60601 1 IEC 60601 1 2 BE 4 2 2 IEC 60601 1 1 4 3 4 3 1 IEC 60825 1 8 2 0 IEC 60825 1 4 2 4 3 3 _ TEC 60825 1 4 3 4 3 4 IEC 60825 1 4 4 4 3 5 _ IEC 60601 2 22 4 9 2
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