風(fēng)險管理報告(dfmea(留存版)
【正文】 等級 定性描述 1 無 No effect on patient status or procedural oute 2 很低 Minimal to alteration of patient’s baseline status. No promise in final result. 3 低 Significant alteration of patient’s baseline status. 4 中 等 Serious alteration in patient 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(zhǔn)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 tes
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