画像診断装置の品質管理と法的環境
Contents
1. PBL X 19702. EU 2001 User directive 8
3. 1 7 7 77
4. 2 1996 5 11 2
5. 15 17 20 14 20 3 PL 2 1
6. 21CFR1020 30 CFR Code of Federal Regulation 21CFR FDA paragraph A paragraph C paragraph D paragraph GG paragraph H 2 FDA FDA
7. 8 1 63 2 47 6 495 77 3 3 63 2 2
8. X 2 3 18 19 20
9. 1980 JCAEEO JCAHO Joint Commission on Accreditation Health Care Oreanization JCAHO Vol 11 1999
10. EC 1973 1940 X 1987 TUV TEC61223 X X 3 4 16 18 3 X
11. 3 20 4 5 1
12. 3 27 4 Vol 11 1999 6 IEC61223 X DIN68 IEC EC61223 1973 X Reontogen Verodnug X ROV 1987 1 5 48
13. 9
14. 21 5 TUV 6 1 EC Medical Deyice Act 1994 8 EC X 10 49 6 2 823 7
15. PL 4 10 1 1 9
16. Vol 11 1999 PL IEC61223 X
17. 2 8 3 9 9 7 9 12 8 3 26 263 9 12
18. 1 X 2 X 3 4 X 4 X 1 2 2 X 3 X 10 4
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