2006実施におけるよくある質問
Contents
1. AE AE EN 62304 28 2 6 6 2 6 7 2 6 82. QMS HR 9 AE 2 3 13 2 3 14 2 3 15 DEY EN 62304 5 1 1 e 5 6 8 5 7 2 6 1 9 6 2 2 FAQ 1 1
3. 4 3 EN 62304 ETE EN 62304 C
4. FAQ AE 26 2 5 13 2 6 2 6 1 NB indirectly C
5. AE 5 3 B C 5 4 2 C AE 5 1 1 7 3 3 8 24 A B C B C A B C
6. FDA EN 62304 IEC A B C FDA Minor Moderate Major EN 62304 4 3 FDA
7. EN ISO 13485 EN 62304 EN ISO 14971 AF EN 62304 EN ISO 14971 EN ISO 13485 MDD 14 2 3 3 2 3 4 2 3 5 2 3 6 2 3 1 FDA 11 AE EN 62304
8. C B non serious injury Intended Use X a indirectly
9. a SAAS b FPGA c FPGA d e Medical Apps f Excel macros g h i D AF intended Use a SAAS
10. SOUP 12 SOUP ISO 13485 SOUP 36
11. 5 4 5 5 SOUP EN 62304 SOUP SOUP SOUP MDD 2 HBOR THERE KERERE ALD CHR ANEMREIL A RO oh ERMER ELT KERANI EPE AIEEE 2 2 EN 62304
12. C 5 5 3 5 5 4 30 2 6 10 2 6 11 2 7 2 7 1 2 7 2 EN 62304 AE
13. SOUP MDD EN 62304 ELF NB EN 62304 private IT EN 62304 ELF EN 62304
14. ELF 4 2 7 4 3 c 5 1 1 5 2 5 2 3 5 3 5 4 5 5 5 6 5 7 5 7 1 1 2 5 7 4 5 7 5 5 8 5 8 4 5 8 5 8
15. 40 1 MDD 1 6 BUD XILO ERB eh AE CEAT EIN DO DOS FHKE ER KE REXILAAEABERM BH AXIARI SI ODIRELELAT SEBO HED E Rita 2 HEED DORE XSI E A FEL BRULEE RES SPOR ITF ORE WEROLROREGHREEEE
16. C C AE EN 62304 7 2 2b 7 2 2 C 24 2 5 7 2 5 8 2 5 9 C
17. pdf AIF EN 62304 6 2 4 8 2 1 ISO 13485 4 1 pdf 1 2 3 3 2 3 4 a EN 62304 MDD b EN 62304
18. SOUP FAQ2 7 IE C C
19. 3 1
20. a b ELF a b the state of the art EN 62304 EN 62304 MDD EN 62304 2 E IEC 62304 Amd Ed 1 2013 7 CD E 32 2 7 5 Application of software lifecycle PROCESSES for LEGACY SOFTWARE
21. C B B B A A B B ATE ISO 13485 7 5 2 1 SOUP CH AE
22. C CPU CPU 1 2 FTA FMEA 3 21 2 5 3 OL
23. SED CHS FHANSDUEKA OC CEFR CHEB CAEKSIK LL FOE Y SRA EEL TFE F S7O DKEAFHESG E ZEILGELGYIAILIP PITAL REG GES b7 SEBE CEG MHFO DOKAAEIUS E KEIKGES OBIE REIKLBELAL YIKILP PAT LOM BEBENSECER BICIELL FUL FITAN ZEILBELAZUYIKILI FATAL LEB CELL e FITRAOKSAMELANS KENES SEYIILIPATLEKE ILFRELEUY PAILS FAT LOMA CHAS EYAIKILIL ATL Pl Ald FARYYL LRA RUXEY PIER DKEA 1 C B COTS B A COTS COTS B COTS
24. AE 5 EN 62304 ELF 6 2 1 6 2 4 6 2 5 2 3 1 EN 62304 TickIT Plus IE TickIT EN ISO 9001 EN 62304 ISO 20000 ITIL AE ISO IEC 20000 ITIL
25. 29 2 6 9 ISO 13485 O 7 5 2 1 5 4 2 B 5 4 1 RB C 5 4 2 C 5 5 5 5 5 5
26. Charles Rei 43 44 2013 7 JEITA IEC TC 62 SC 62A JWG 3
27. 4 1 EN 62304 AIF NB EN 62304 EN 62304
28. EN 62304 1 2 EN 62304 1 2 AE 25 2 5 10 2 5 11 2 5 12 EN 62304 3 FDA 3 AE EN 62304
29. ELF intended Use H MDD GPSD MEDDEV 2 1 6 4 a Tb MDD V M b EC 62304 T 3 OK NB AE a 11 Ib
30. ISO 14971 23 2 5 5 2 5 6 A B A 1 C B B A ISO 14971
31. EN 62304 EN 62304 ISO IEC 20000 1 ITIL EN 62304 IT EN 62304 16 2 3 12 EN 62304
32. intended Use AE EN 62304 C intended Use ISO 14971 intended Use C TCT
33. IEC 60601 1 4 PEMS IEC 60601 1 14 EN 62304 AF IEC 62304 2015 IEC 60601 IEC 62304 IEGC 60601 IEC 62304 IEC 82304 AE IEC 82304 3 AE EN 62304 3 12
34. IT EN 62304 FDA ELF a EN 62304 PEMS EN 60601 1 3 14 IEC 82304 ISO IEC 82304 1 Healthcare software systems Part 1 General requirements EN ISO 13485 2012 7 3 6 SO 13485 EN 62304
35. EN 62304 Ae 2 4 2 4 1 2 4 2 2 4 3 EN 62304 EN 62304 EN 62304 6 7 2 1 B C AIF EN 6230
36. IEC 61508 SIL EN 62304 AE SIL 1 SIL 4 3c 7 2 2b
37. EN 62304 1 e SOUP IEC 62304 2 EN
38. IEC CD 82304 2 2 2 2 1 2 2 2 2 2 3 MDD EN 62304 AE EN 62304 MDD EN 62304 EU intended Use
39. 4 3 a ISO 14971 EN 62304 AE EN 62304 ISO 14971 4 2 19 2 4 4 2 4 5 1ISO 14971 EN 62304 1SO 14971 EN 62304 7 IEC TR 80002 1
40. Web EN 62304 http https ATE EN 62304 2 2 EN 62304 AE 5 2
41. b A B ELF IEC 62304 1 ISO 14971 COCIR EUROM Position Paper on Direct Diagnosis 2011 10 14 FAQ 4 27 2 6 2 2 6 3 2 6 4 2 6 5 AE
42. expertise decision MDD MDD b FPGA FPGA EN 62304 c FPGA FPGA IEC 62304 d 2007
43. 10 11 SOUP 37 PEDERE ae la SOUP 1b SOUP a 3 He it 4 NO EEO YES Ea C D YES F DX D EPES Dai C SEERA 10 SOUP
44. ELF 100 IE DEY ERRE SO 14971 2007 1 2 3 ERRE
45. SOUP EN 62304 AIF CMS EN 62304 5 1 4 5 5 2 5 8 8 ISO 13485 7 5 2 1 SOUP SOUP Software of Unknown Provenance AE EN 62304 EN 623
46. intended Use B A 1 C B BAYS A 4 3 d
47. IEC 62304 IEC ISO NB Jomuna Choudhuri VDE Testing and Certification Institute Koen Cobbaert Agfa Healthcare Georg Heidenreich Siemens AG Healthcare Sector Frans Jacobs Philips Healthcare Gerd Neumann Siemens AG Healthcare Sector Michael Bothe VDE Testing and Certification Institute Peter Linders Chair Technical amp Regulatory Affairs Committee COCIR FAQ FAQ62304 vde com FAQ IEC 62304 IEC 62304 AIMDD CMS COCIR COTS EEC EUROM VI FPGA GPO IEC ISO IVDD MDD MEDDEV MPBetreibV Active Implantable Medical Device Directive
48. Configuration Management System European Coordination Committee of the Radiological Electromedical and Healthcare IT Industry Commercial off the shelf European Economic Community European Federation of Precision Mechanical and Optical Industries Medical Technology Field Programmable Gate Array General Practitioner s Office International Electrotechnical Commission International Organization for Standardization In Vitro Diagnostic Directive Medical Device Directive Non binding guidance for Medical Devices endorsed by EU Member States EU http ec europa eu health medical devices documents Medizinprodukte Betreiberverordnung Verordnung uber das Errichten Betreiben und Anwende
49. IE a intended Use MDD b EN 62304 NB NB AIF NB ISO IEC 17021 DRE NB ISO 9001 ISO 13485 EN 62304 13 2 2 8 2 3 2 3 1 2 3 2 ISO IEC 17025 EN 62304 2 1 5 ISO IEC 17065 EN 62304 ATE EN 62304
50. FAQ 3 DVD B B B AE B C
51. 9 1 92 9 3 8 9 4 H9 4 82 9 a 9 D 9 a 9 co 1 35 2 SOUP SOUP 2 7 1 2 7 3 SOUP 2 2 SOUP
52. B C B B 5 5 5 B ATE B
53. QMS EN ISO 13485 FDA 21 CFR 11 FDA 21 CFR 11 IEC 62304 FDA ELF EN 62304 EN ISO 14971 EN ISO 13485
54. IV V LAL MDD b QMS 3 MDD IL 3 EN 62304 2 2 4 2 2 5 2 2 6 2 2 7 NB EN 62304 EN 62304 IEC 62304 IE IEC 62304 FDA 13 8 YY T 0664
55. EN 62304 AE IEC 62304 2 MDD 2 1 2 1 12 2 1 13 2 1 14 2 1 15 A A EN 62304 A AE A
56. FDA EN 62304 intended Use 2 1 8 2 1 9 2 1 10 2 1 11 EN 62304 MDD AE EN 60601 1 3 14 MDD EN ISO 13485 EN 62304
57. EN 62304 5 1 8 5 2 6 5 5 2 6 2 4 8 2 1 9 4 B C 3 EN 62304 ELF EN 62304 5 1 1 EN 62304 AE EN 62304 5 1 15 2 3 7 2 3 8 2 3 9 2 3 10 2 3 11 5 9
58. 41 4 PRES TICE PASEO FEMA HERI Ab e ECG 42
59. Technical debt EN 62304 B 8 2
60. NB AE EN 62304 MDD the current state of the at NB AE EN 62304 A
61. EN 62304 2006 MDD 93 42 EEC 1 hk 2013 4 5 2 1 EN 62304 2 2 LU 23 FA DPA FWP AA 24 2 6 2 7 SOUP 1 2 SOUP 3 4 COCIR 2011 FAQ 62304 EC 62304 ERAY 2006 EN 62304 3 AIMD 90 385 EEC MDD 93 42 EEC IVDD 98 79 EC
62. IE 6 2 3 4 EN 62304 AF 2 3 11
63. EN 62304 2006 NB NB NB NB 7 73
64. B C NO YES SOUP 1 SOUP 12 SOUP 13 SOUP 14 2 SOUP 38 3 3 EN 62304 2 6 7 5 1 1 c 7 3 3 ORE 8 2 4 B TATOIIA B C
65. NBs PEMS SAAS SDD SIL SOUP TUV VDE Notified Body Notified Bodies NB Programmable Electrical Medical System Software as a service Software Detailed Design Safety Integrity Levels as per IEC 61508 IEC 61508 Software of Unknown Provenance Technischer Uberwachungsverein Verband der Elektrotechnik Elektronik und Informationstechnologien 2 1 2 1 1 2 1 2 2 1 3 2 1 4 EN 62304 EN 62304 MDD 93 42 EEC IE 3 MDD IF MEDDEV 2 1 6 2 AE
66. 1 2 3 1 6 2 1 2 ws ao 1 6 213 3 2 gt PERI RER 3 6 2 2 5 6 8 9
67. X 4 X 1 2 3 ARRE 4 Ce 20 2 4 6 2 5 2 5 1 2 5 2 EN 62304 BE ISO 14971 IEC TR 80002 1 IE 3
68. 4 SOUP 2 3 10 11 SOUP SOUP SOUP 12 SOUP SOUP 10 SOUP B C JEF 11 SOUP
69. 3 39 4 COCIR 2011 2 5 13 93 42 EEC 3 2 10 COCIR EUROM VI ZREBES SHED al a CHO ed BED BRGELEAHIOCAO EEE PH ae THIF SB CLF BIS GE ML RIOR WAIL WMBORERE FR PIPER OG DORE BE BHOZLIACKEREtKSS ERZGCLEFIINDX SOR ME HIB IF SBREERS TOBA HILIR Ib CHS COCIR EUROM WI ZHEBELS ORDO RATC ERRITO ED A EC baE 1 PEE WAIL REBEL ILIBE BSUS 2 BEGFEBFHFOCAZAORE 7 2 ED ILIDA a AL HED aC OL FOFEDM A REILZEGEER 3 BEIOHED WAIE DAO BRE FR PRAIEROFZAIODELGE BBZOZLMAOEEREGKSS EBEBGLEFSHNDX SOETE COG BEBILIZZA Ib
70. A COTS AE 3 29 COTS SOUP EN 62304 5 3 3 5 3 4 5 3 6 SOUP SOUP SOUP 5 3 3 5 3 4 Intended Use SOUP 5 3 6 22 2 5 4 SOUP SOUP SOUP A B C EN 62304
71. MDD Intended Use e MDD EN 62304 d MDD EN 62304 MPBetreibV g 2 1 3 h 2 1 5 2 1 6 2 1 7 i j MDD
72. 04 4 1 EN ISO 13485 SOUP SOUP 5 1 7 5 3 3 5 3 4 6 1 7 1 2 7 1 3 8 1 2 FAQ 2 EN 62304 SOUP SOUP AE SOUP 5 4 5 5 SOUP 31 2 7 3 2 7 4 SOUP EN 62304 AE SOUP 3 29 SOUP
73. 4 7 2 1 AE 1 C B B A 4 3 a
74. 62304 AF EN 62304 33 1 David A Vogel 2010 77 A 30 A Medical Device Software Verification Validation and Compliance Artech House ISBN 978 1 59693 422 1 2 MEDDEV 21 6 2012 7 A Guidelines on the qualification and classification of stand alone software used in healthcare within the regulatory framework of medical devices 3 IEC 62304 2 MIARE Ela FC 2014 EDS 2015 FILFATEP EAN WEG 4 IEC 82304 7 Mkt RAE PC 2015 FILFEITE PESN TUE 5 COCIR EUROM VI Position Paper on Direct Diagnosis 2011 10 A 14 A 6 AAMI TIR 45 Guidance of the use of AGILE practices in the development of medical device software 2012 34
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