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tient baseline status. May involve 5 高 Critical alteration in patient baseline status. 6 很高 Deathdevice related. 7. 探測度等級的評定準則 等級 定性描述 1 幾乎肯定 Can be detected prior to engineering prototype: previous product history, relevant research phase testing 2 很高 Can be detected prior to design releasing: DVR/DVL testing, animal study results and /or protocol required testing 3 高 4 中上 Can be detected prior to mass production: Process and Product Validation efforts 5 中等 6 小 Can b