市川義人
Contents
1. Application specification RW ERR UI 4 4 1 4 1 12. 19 ml 255mL h 1100mL 33 Annex EEE ISO 14971 4
3. 10 8 80 22 1 2
4. 4 1 2 4 4 1 4 1 3 4 4 2
5. lt 5 0 0 22 0 1 i 2
6. 23 20 18 909 6 1009 24
7. IEC 60601 2 2 4 4 rE OLYMPUS MEDICAL SYSTEMS
8. 5 5 5 6 a ME 5 8 a 5 9 19 1 2 3
9. 6 0 0 Kiara 7 i
10. 2013 1 10 IEC 62366 1CDV IEC 62366 2DTR IEC ISO 62366 2007 UI UI 1 2 3 4 4 1 4 1 1 4 1 2 4 1 3
11. 4 3 0 lt 5 5 1 ffg 5 2 5 3 4
12. 4 2 4 3 5 5 1 5 2 5 3 5 3 1 5 3 2 5 4 5 5 5 5 6 5 7 UI 5 8 5 9 6 7 1 9
13. 2 ISO14971 5 4 1
14. 11 UsABILITY ErFECTIVENESS FFFICIENCY 13
15. IEC ISO 62366 IEC SC62A JWG4 IEC 60601 1 6 2005 ISO JWG4 2007 1 22 25 JEITA CDV FDIS EP RE RRR 2007 7 FDIS r2007 9 62A 589 RVD FDIS IS 2007 10 IS IEC 60601 1 6 2013 AM1 ED3 IEC 62366 2011 9 JWG4 IEC 62366 TR
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