未承認医療機器の臨床研究実施の手引き（案）
Contents
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18. 1 I IV IEC60601 1 2 BC 1 i
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20. 9 10 11
21. SO FDIS 14155 2011
22. 5 30 1 7 E 4 E
23. 4 E Tl 16 17 18 19 20 i
24. CRF Case Report Form SOP
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40. X CT MRI IEC60601 1
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68. E 11 SOP Standard Operating Procedure CRF Case Report Form
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