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對于中、低使用風險醫療器械,可用性工程研究資料“使用錯誤評估報告”中主要包含哪些內容?
【問】對于中、低使(shi)用(yong)(yong)風險醫療(liao)器械,可用(yong)(yong)性工程研(yan)究資料“使(shi)用(yong)(yong)錯誤評估報告”中主要包含哪些內容?
【答】使(shi)(shi)用(yong)(yong)(yong)錯(cuo)誤評估報(bao)(bao)告(gao)(gao)(gao)用(yong)(yong)(yong)于(yu)細(xi)化風(feng)(feng)(feng)(feng)險管理(li)報(bao)(bao)告(gao)(gao)(gao)關(guan)于(yu)可用(yong)(yong)(yong)性方(fang)面(mian)的(de)內(nei)容(rong),僅適(shi)用(yong)(yong)(yong)于(yu)中、低使(shi)(shi)用(yong)(yong)(yong)風(feng)(feng)(feng)(feng)險醫(yi)(yi)療(liao)(liao)(liao)器(qi)械(xie)(xie)(xie),包(bao)括基本(ben)信(xin)息(明(ming)確(que)(que)(que)申報(bao)(bao)醫(yi)(yi)療(liao)(liao)(liao)器(qi)械(xie)(xie)(xie)的(de)名稱、型號(hao)規(gui)格、預期用(yong)(yong)(yong)途、適(shi)用(yong)(yong)(yong)人群、結構組成)、使(shi)(shi)用(yong)(yong)(yong)風(feng)(feng)(feng)(feng)險級別(bie)(明(ming)確(que)(que)(que)申報(bao)(bao)醫(yi)(yi)療(liao)(liao)(liao)器(qi)械(xie)(xie)(xie)的(de)使(shi)(shi)用(yong)(yong)(yong)風(feng)(feng)(feng)(feng)險級別(bie),并詳述判定理(li)由(you))、核心要(yao)素(明(ming)確(que)(que)(que)申報(bao)(bao)醫(yi)(yi)療(liao)(liao)(liao)器(qi)械(xie)(xie)(xie)的(de)用(yong)(yong)(yong)戶(hu)、使(shi)(shi)用(yong)(yong)(yong)場景、用(yong)(yong)(yong)戶(hu)界面(mian))、同類醫(yi)(yi)療(liao)(liao)(liao)器(qi)械(xie)(xie)(xie)上(shang)市后使(shi)(shi)用(yong)(yong)(yong)問(wen)題分(fen)析(提供(gong)同類醫(yi)(yi)療(liao)(liao)(liao)器(qi)械(xie)(xie)(xie)上(shang)市后使(shi)(shi)用(yong)(yong)(yong)問(wen)題分(fen)析報(bao)(bao)告(gao)(gao)(gao),可參(can)考臨床(chuang)文獻(xian)檢(jian)(jian)索(suo)報(bao)(bao)告(gao)(gao)(gao)格式,包(bao)括檢(jian)(jian)索(suo)對象、檢(jian)(jian)索(suo)內(nei)容(rong)、檢(jian)(jian)索(suo)結果等(deng)內(nei)容(rong))、使(shi)(shi)用(yong)(yong)(yong)風(feng)(feng)(feng)(feng)險管理(li)(提供(gong)申報(bao)(bao)醫(yi)(yi)療(liao)(liao)(liao)器(qi)械(xie)(xie)(xie)的(de)風(feng)(feng)(feng)(feng)險管理(li)文檔并明(ming)確(que)(que)(que)使(shi)(shi)用(yong)(yong)(yong)風(feng)(feng)(feng)(feng)險管理(li)相應內(nei)容(rong),或(huo)者提供(gong)使(shi)(shi)用(yong)(yong)(yong)風(feng)(feng)(feng)(feng)險管理(li)文檔)、結論等(deng)內(nei)容(rong)。
本(ben)文由廣州(zhou)佳譽醫療(liao)器(qi)械有限公司/佛山浩揚(yang)醫療(liao)器(qi)械有限公司聯(lian)合編輯