08 医療機器のリスクマネジメント
Contents
1.2.
3.
4. m 1
5. S1 S2
6. 6 6
7. 2
8. HHHHHHHHHH AVMANAGEMENT 14 3 1
9. HHHHHHHHHH AVMANAGEMENT 4 f ie AN MRI
10. a b
11. HHHHHHHHHH AVMANAGEMENT 12 5 a b c
12. ALARP
13. ALARP
14. 6
15. a b
16. HHHHHHHHHH AVMANAGEMENT
17. ETA FTA FMEA ETA FTA HHHHHHHHHH AVMANAGEMENT 2 FMEA Failure Mode and Effects Analysis FMEA
18. 1 2 3 OETA S F DLE HHHHHHHHHH AVMANAGEMENT 4 FTA Fault Tree Analysis 1959
19. es E F e HRP HHHHHHHHHH AVMANAGEMENT 2 2 1 M2 2 M2 3 M2 4 5
20. KI B SEM OMIL x 4 52727 x x m2 SDpH x 3 ETA Event Tree Analysis
21. 1 2 3 1 2
22. 9 HHHHHHHHHH AVMANAGEMENT 13
23. 3B4E ERA EO SITAS D BEL BLEL OE OE DE D T A V MANAGEMENT 18 19
24. 1 2 2 FTA HHHHHHHHHH AVMANAGEMENT 5 HAZOP
25. 2 19 2 20 2 21 2 22 HHHHHHHHHH AVMANAGEMENT 3
26. 6 2 6 2 6 3 CX UAI 1E 7 6 4 6 5 ae 6 6 2 6 7 7 8 9 9 g e94940494444959450949444 0244 484092 2940400 2 6929 9042 949495 54 4840 HHHHHHHHHH AVMANAGEMENT 11
27. HHHHHHHHHH AVMANAGEMENT 16 2 1155
28. HHHHHHHHHH AVMANAGEMENT 15 3 OISO14971 3 A B ALARP C ALARP E OH g OALARP As Low As Reasonably Practicable
29. 2
30. OQ Q 8 UZ208T1f j Keesscssssessecenacaceotab60s 0000009000009 9909900000 00099009 009000909000 90 0094000920000 600000090000 00000000 00940009 0009 0000000000900 094099000000 0000 90900000 000009 040000000000 09 9009400099900 96000000 000006002000600000 080600000000 000540400090 00 009000 09000000000 00000 900000 00000000008 HHHHHHHHHH AVMANAGEMENT 4 10 4 2 4 3 4 4 5
31. 10 M2 2 11 2 12 HHHHHHHHHH AVMANAGEMENT 2 13 2 14 2 15 2 16 2 1 2 18
32. 0SHA 1 HAZOP HAZOP Guide Word No Not More Less As well as Part of Reverse Otherthan m PC 8 HHHHHHHHHH AVMANAGEMENT 2 ISO14971 2012 1 WIT TO OT
33. a b ALARP C 4 O 2
34. HHHHHHHHHH AVMANAGEMENT 17 a b CO
35. HOK NG gt L1f amp e dB HH ODISREGRIREBUZS DA RUND
36. veeress seesserserevesessesesecfasseresssessessersasssassesasessseeesesesssnsessre ott essessaetes esosrsesedest esseenedesassatessceresrssmsesseresteseniaestresesetessesasse EE E EE EE EE EE arersss roseaseseseereersesessaeseeseseree rereseeeeseeraesssrere eerascnees nene ee b et MOT DP HPLC NR TAERURERTE SERIE ISSUE EETUAOTUYE SR SS 2 1 2 3 A REPRE b 5 10 Sa 6 wo aram
37. rd n w 1 8 9 5 aaa ee oo aaa ae 6 7 10 A SS B ae C ette a em
38. M2 6 M2 1 2 0 M2 9
39. Fefgriiaa A720 TZXAbE D ELE BLE EL OE D D T AVMANAGEME NT 1 IS013485 QMS FMEA ETA FTA IS014969 1 LIALARP
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