JAHIS 医療情報システムの 患者安全に関する リスクマネジメント
Contents
1.2. AA 3 1 2 A 3 1
3. 2R208
4. 6 IEC 62304 2006 5 6 5 7 100
5. UE Ce ISO 14971 2007 5
6. 5 1 0 5 1 5 2 5 4 5 5 6 5 8 Ne NR 2 2 7
7. Copyright 2010 1 WE LIP 1 2 kk 3 HOE RC A fc 4 15991 CR HP 7 5 nA A 2A RR hh 1111 1 ll 1f1 k1144a 8 CF XR OO 8 0 RG Tt i A 9 S00 kk Nc i 10 6 ka i iiii ll 41 11 CE SC i 11 6 2 RG RT TEAL A RN GI 444 12 63 RT GA EN RN ii Sk 13 7
8. ISO 14971 2007 4 1
9. ID 2 A 2 EA I EO A 31
10. 3
11. 8 3 IEC80002 18 IEC80002 1 ISO14971 ISO14971 2007 8
12. IEC 62304 B 1 IEC 62304 3 7 amp 1 A 2 B
13. lt gt 16 JAHIS 2010 All right reserved 3 4b IBC62304 2004 6 7 3 3 8 4 IEC80002 19 IEC80002 1 ISO14971 ISO14971 2007 9
14. IEBC60601 1 6 IEC62366 2007 9 1 DE EAR SO 012291 2 3 1 1 1 1
15. IEC 62304 2006 5 4 AnnexB IEC 62304 2006 5 5
16. 0 S0UP 25
17. 3 a b c d lt gt 14 JAHIS 2010 All right reserved 7 3 1
18. 1 2 ISO 13485 2003 8 2 1IEC 62304 2006 6 BC 62304 2006 9 IEC62304 2006 6
19. SOUP IEC62304 2006 7 4 8 2 9 7 8 5 IEC80002 1 Annex E Safety Case IBC80002 1 Annex E UK Mod DefStan 00 56
20. 7 1 2 1 5 2 I ear 7 1 2 7 2
21. 5 1 JIS T 62304
22. lt gt 36 JAHIS 2010 All right reserved E I E C80001 1 Application of risk management for IT networks incorporating medical devices IT IT IT 3
23. ISO 14971 2007 5 HIV TIVD IVD lt gt 34 JAHIS 2010 All right reserv
24. JIS T 62304 3 24 3 37 software item ISO IEC 90003 2004 3 14
25. lt gt 17 JAHIS 2010 All right reserved IEC62304 2006 9 SOUP SOUP
26. IEC62304 B 4 JIS Q 13485 JIS T 14971 JIS T 62304 IEC
27. GHTF JAHIS
28. NHS 2006 3 ISO TC215 3 ISO TC215 IEC SC62A IEC TR80001 2 CEN CENELEC WG 2010 3 MDD FDA
29. SSASLSISIS JIS JIS JIS JIS Q 13485 JIS T 14971 JIS T 62304 IEC62366 IEC60601_1 6 IEC TR80002 1 IEC80001 1 IBC80001 2 XX lt gt 1 JAHIS 2010 All right reserved lt gt JIS T 14971 JIS T 62304 IEC62366
30. C 2000 2008 3 lt gt 27 JAHIS 2010 All right reserved
31. 1 GHTF JIS T 62304 3 11 JIS Q 13485 2005 3 7 JIS T 14971 2 7 3 8 objective evidence JIS T 14971 2003 2 8 ISO 8402 1994 2 19 3 9 procedure JIS T 14971 2003 2 9 ISO 8402 1994 1 3 3 10 process JIS T 14971 2003 2 10 ISO 8402 1994 1 2 3 11 record JIS T 14971 2003 2 11 ISO 8402 1994 3 15 3 12 residual risk JIS T 14971 2003 2 12 ISO IEC
32. C lt gt PA JAHIS 2010 All right reserved 10
33. C A 5 C HIS A C
34. B C 6 1 4 SOUP a A B C b A B C c B C 6 2 6 2 1
35. es SOUP ISO 14971 2007 4 3 FMEA FTA FMBA FTA
36. C A 3 lt gt 9 JAHIS 2010 All right reserved C X Y A C W B C 5 3
37. NL2RNS lt gt 35 JAHIS 2010 All right reserved D 1 IEC62304 2006 IEBC62304 TR TTT DU
38. a b 1 C 2
39. lt gt 32 JAHIS 2010 All right reserved D I EC T R80002 1 Annex C D 1 ISO14971 2007 IEBC62304 2006 D 1 IEBC62304 2006 IEC62304
40. JIS T 14971 2003 2 22 3 23 activity JIS T 62304 3 1 3 24 anomaly JIS T 62304 3 2 IEEE 1044 1993 3 1 3 25 architecture JIS T 62304 3 3 IEEB 610 12 1990 3 26 change request JIS T 62304 3 4 3 27 configuration item entity JIS X 0160 1996 3 6 JIS T 62304
41. JIS 2010 9 gt gt
42. a a
43. C X W Z 3 sk Eg Z lt X W A B 0 EE W Z Y C C
44. 8 3 lt gt 10 JAHIS 2010 All right reserved EN JIS T 14971 ya JIS T 62304
45. FA 11 5 RR 15 15 CA 0 2 etc 100 1500 1 1 10 10 30 JAHIS 2010 All right reserved lt gt
46. 6 2 A B C lt gt 13 JAHIS 2010 All right reserved JIS T 62304
47. B A 3 2 3 2 A B C
48. 2 3 6 JIS T 62304 3 13 3 32 process JIS T 62304 3 14 JIS Q 9000 2006 3 4 1 3 33 regression testing JIS T 62304 3 15 ISO IBC 90003 2004 3 11 3
49. AA gt SOUP lt gt 33 JAHIS 2010 All right reserved D 1 IEC62304 2006 IEC62304
50. SOUP SOUP SOUP SOUP SOUP EC62304 2006 CL LEELA CU90Y 4 2 SOUP SOUP
51. lt gt 18 JAHIS 2010 All right reserved lt gt 19 JAHIS 2010 All right reserved 9 RE Ra
52. lt gt 30 JAHIS 2010 All right reserved C 9 I EC62366 3 IEC62366 2007 2 gt 2 5Kg
53. IEC 62304 2006 6 1 CE IEC 62304 2006 6 2 6 3
54. B 1 1 6 HIS A A 0 TEF A CC C B 1 1 lt gt 29 JAHIS 2010 All right reserved
55. 1 2007 Medical devices Applocation of usability engineering to medial devices IBC62366 2007 io
56. IEC TR80002 1 2009 9 21 IBC TR80002 1 Annex C D 6 1
57. e B C 6 1 2 a b B C 6 1 3
58. E 7 MENS 4 lt gt 38 JAHIS 2010 All right reserved IT IT
59. lt gt 26 JAHIS 2010 All right reserved A SONG A C
60. 1 CU 2 IEC 62304 2006 3 33 JIS Q9000 2006 ISO 9000 2005 3 8 4 verification FDA General Principles of Software Validation GPSV 3 1 2
61. 5 3 1 2 8 MP hr 2 5 1 5 2 8 1 8 2 8 3 3 8 1 SOUP 9 18 2 4
62. 1 JPEG rnpe 3 he
63. GPSV 4 10 2 FDA 21 CFR 820 Sec 820 3 Intended use JIS Q9000 2006 SO 9000 2005 3 8 5 validation EDA GPSV 3 1 2 Intended use
64. 1 10 2 2 1 3 4 5 6
65. KRK KK 14 NR 14 7 2 lt lt 14 8 ik 15 8 2 2 RE AA A 2 14444A 44444i4 16 8 1 JIST 62304 8 II 16 8 2JIST623049 16 8 351EC80002 1 8 EkilAk kh lh ef A a g 16 8 4 IEC80002 1 9 kk 7 8 5 IEC80002 1 ANNEX E SAFETY CASE 18 ON ER i 20 OM CRA OM GG GG dA 20 9 2 ES 21 10 kk 22 00 1 BB 209 HK OH 10 FR i 292 OS LA II 23 0 gc 23 A 25 B
66. JIS T 14971 2003 2 17 ISO IEC Guide 51 1999 3 11 3 7 3 18 risk management JIS T 14971 2003 2 18 JIS T 62304 3 19 3 19 risk management file JIS T 14971 2003 2 19 JIS T 62304 3 20 3 20 safety JIS T 14971 2003 2 20 JIS T 62304 3 21 ISO IEC Guide 51 1999 3 1 3 21 severity JIS T 14971 2003 2 21 3 22 Verification RIE
67. 20 1 1 lt gt 2 JAHIS 2010 All right reserved RE
68. 9 lt gt 6 lt gt 28 JAHIS 2010 All right reserved B
69. E B 8 lt gt 23 JAHIS 2010 All right reserved 4 JIS Q 27001 JIS Q 27002 ISMS Information Security Management Systems 2
70. C B C lt gt 3 2000 2008
71. ANOMALIES ANOMALY ANOMALIES
72. vigilance event evidence 10 1 1
73. 6 1 4 B C 6 3 6 3 1 A B C 6 3 2
74. JIS T 62304 IBC80002 1 JIS T 62304 IEC80002 1 Safety Case JIS T 62304 IEC80002 1 8 1JIS T 62304 8 5 3
75. 8 8 1 8 2 8 3 9 IEC 722 06 1 5 1 5 1 5 8 lt gt 8 JAHIS 2010 All right reserved 8 5
76. C B C 6 2 4 B C 6 2 5 B C 6 2 6
77. IT IT IT T lt gt 37 JAHIS 2010 All right reserved The RESPONSIBLE ORGANIZATION TOP MANAGEMENT cS Clinical Department 2 2 Biomedical Policies Engineering Department Processes ca Procedures IT Department MEDICAL IT Supe NETWORK Visea Crea RISK MEDICAL IT MANAGER Other NETWORK RISK MANAGEMENT FILE RESIDUAL RISK 8 s Sub MEDICAL MEDICAL contractor DEVICE DEVICE manufacturer manufacturer or other IT or other IT technology te
78. 29 C TIEC62366 ki 31 NBEO RO LOANNEX CO So ii 33 EE 000 i 37 So 40 111 1
79. ofF the shel JIS T 62304 3 29 3 42 system JIS T 62304 3 30 JIS X 0160 1996 3 31 3 43 task JIS T 62304 3 31 3 44 traceability 6 ISO 9000 2000 ISO 13485 2003 JIS T 62304 3 32 S 3 45 verifcation 8 1
80. 3 GPSV 4 9 4 a b c d 7 V model lt gt 15 JAHIS 2010 All right reserved 8
81. 10 4 1 JIS Q 13485 SO 9001 4 2 4 58 2
82. 2 3 4 5 6 1 2 1 3 1 ISO14971 2007 4 2 2 2 lt gt 20 JAHIS 2010 All right reserved 14971 2007 4 3 PT 1 4 Ne
83. JIS Q 9000 2006 3 8 4 2 JIS T 62304 3 33 3 46 version 1 2 JIS X 0160 1996 3 37 JIS T 62304 3 34 3 47 usability LIEC 62366 2007 3 17 4 CEN European Commnittee for Standardization CENELEC European Committee for Electrotechnical standardization FDA Food and Drug Adminstration FMEA Failure Mode and Effect Analysis FTA Fault Tree Analysis GHTF Global Harmonization Task Force IEC The Internat
84. gt 105 0001 1 19 9 TB 6E 03 3506 8010 FAX 03 3306 8070 lt gt 41 JAHIS 2010 All right reserved
85. lt gt 24 JAHIS 2010 All right reserved A IEBC 62304 A 1 IEC 62304 3 7 amp 1 A 2 B 3 C A 2
86. 8 2JIST623049
87. 2 JIS T 14971 9 8 4 IEC 80002 1 9 E E 1 E 2 3 IEC 80001 1 Application of risk management for IT network incorporating medical devices ITT
88. 3 1 A 2 B 3 C 100 ERO
89. JIS T 14971 2003 2 5 3 6 manufacturer JIS T 14971 2003 2 6 JIS T 62304 3 10 3 7 medical device
90. 0 lt gt A 3 0 A 0
91. 2 i 2 1 1 2 2 2 2 3 3 NE 1 2 3 5 1
92. SOUP A B C 6 2 2 A_B C B C A B C lt gt 2 JAHIS 2010 All right reserved 6 2 3 B C
93. 3 5 3 28 deliverable JIS T 62304 3 6 3 29 evaluation entity FEE JIS T 62304 3 7 JIS X 0160 1996 3 9 3 30 medical device software JIS T 62304 3 12 3 31 problem report lt gt 9 JAHIS 2010 All right reserved 1
94. 3 C HIS Hospital Information System HIS 2 HIS 2 5
95. 5 2 5 2 6 1 6 2 6 3 3 6 3 5 3 5 8 6 1 6 3 8 8 1 8 2 8 3 9 IEC 722 06 5 2 5 2 JIS T 62304
96. IT E 1 ITT IT E 3 1 3 IT 2 IT o 3
97. 1 JAHIS lt gt 2 JAHIS 2010 All right reserved 2 ISO 13485 Medical devices Qualhity management systems Requirements for regulatory purDoses JIS Q 13485 2005 ISO13485 ISO 14971 Medical devices Application of risk management to Medical devices JIS T 14971 IEC 60601 1 Medical electrical equipment Part 1 General requrements for basic safety and essential performance IEC 62366 Medical devices Application of usability engineering to medical devices IEC 62304 2006 Medical Device software Software life cycle processes IEC 80001 1 Application of risk management for IT Networks incorporating medical devices IEC TR 80002 1 Medical device software Part 1 Guidance on the application of ISO 14971 to medical device software
98. 2 3 2 ee 9 0 3 9 3 4 225 9 2 Pe
99. E 8 4 E 9 NG ITT IT IEC80001 2 XX Guidance for HDOs Healthcare Delivery Organizations Step by step risk management with e
100. 10 2 1 a b 2 a 1 b 1 c 3 2 lt gt JAHIS 2010 All right reserved eR 10 3
101. lt gt JAHIS 2010 All right reserved 3 JIS T 14971 JIS T 62304 3 1 accompanying document JIS T 14971 2003 2 1 3 2 harm JIS T 14971 2003 2 2 JIS T 62304 3 8 ISO IEC Guide 51 1999 3 1 3 3 hazard JIS T 14971 2003 2 3 JIS T 62304 3 9 ISO IEC Guide 51 1999 3 5 3 4 hazardous situation JIS T 14971 2003 2 4 ISO IEC Guide 51 1999 3 6 3 5 Gntended use intended purpose
102. 2 IT E 1 1 IT 2 IT 2 IT E 2
103. ISO14971
104. J 6 JIS T 14971 lt gt 11 JAHIS 2010 All right reserved 6 1 1 JIS T 14971 a b c SOUP d
105. 34 security JIS T 62304 3 22 JIS X 0160 1996 3 25 3 35 serious injury a b c JIS T 62304 3 23 3 36 software development life cycle model
106. Guide 51 1999 3 9 3 13 risk JIS T 14971 2003 2 13 JIS T 62304 3 16 ISO IEC Guide 51 1999 lt gt 4 JAHIS 2010 All right reserved 3 2j 3 14 risk analysis ON LJIS T 14971 2003 2 14 JIS T 62304 3 17 ISO IEC Guide 51 1999 3 10 3 15 risk assessment JIS T 14971 2003 2 15 ISO IBC Guide 51 1999 3 12 3 16 risk controD 2 JIS T 14971 2003 2 16 JIS T 62304 3 18 3 17 risk evaluation
107. JAHIS 10 101 Japanese JAHIS iation of gt Healthcare 2010 9 Information SYstems Industry JAH 1I S gt 9 1999 NOM To Err is Human IT 2000 JAHIS 2008 11 JAHIS
108. TR80002 1 JIS T 62304 IEC TR80002 1 IEC62366 IEC60601 1 6 IEC80001 1 IEC80001 2 XX 1 A B JIS T 62304 A
109. chnology provider provider A B E 1 E 4 IT IT E 5 IT E 6 IT IT IT IT IT
110. ed D 1 IEC62304 2006 IEBC62304 IEC 62304 2006 5 1 CYS 2
111. granularity JIS T 62304 3 25 3 38 software product JIS T 62304 3 26 JIS X 0160 1996 3 26 3 39 software system JIS T 62304 3 27 3 40 software unit JIS T 62304 3 28 3 41 SOUP Software Of Unknown Provenance lt gt 6 JAHIS 2010 All right reserved
112. ional Electrotechnical Commission IOM Institute of Medicine ISO The International Organization for Standardization MDD Medical Device Directive NHS National Health Service Te Technical Committee SG Sub Committee lt gt 7 JAHIS 2010 All right reserved 5 JIS T 62304 8 5 2 3
113. xamples Guldance for wireless networking Guldance for specifying security requlrements lt gt 39 JAHIS 2010 All right reserved lt gt 40 JAHIS 2010 All right reserved 2010 9 JAHIS 10 101 2010 9 JAHTI SS
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