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《YY／T 0316-2016 醫(yī)療器械 風(fēng)險管理對醫(yī)療器械的應(yīng)用（報批稿）.pdf》由會員上傳分享，免費在線閱讀，更多相關(guān)內(nèi)容在行業(yè)資料-天天文庫。
1、ICS11.040.01YYC30中華人民共和國醫(yī)藥行業(yè)標(biāo)準(zhǔn)YY/T0316-2016/ISO14971：2007更正版代替YY/T0316-2008代替YY/T0316-2008醫(yī)療器械風(fēng)險管理對醫(yī)療器械的應(yīng)用Medicaldevices—Applicationofriskmanagementtomedicaldevices（ISO14971:2007更正版,IDT）（報批稿）（本稿完成日期：2014-11-15）2016-02-01發(fā)布2017-01-01實施國家食品藥品監(jiān)督管理總局發(fā)布YY/T0316-2016/ISO14971:2007更正版目次前言......
2、.............................................................................................................................................................III引言..............................................................................................................................
3、.......................................IV1范圍.................................................................................................................................................................12術(shù)語和定義............................................................................
4、.........................................................................13風(fēng)險管理通用要求.........................................................................................................................................63.1風(fēng)險管理過程..........................................................
5、...............................................................................63.2管理職責(zé).................................................................................................................................................83.3人員資格................................................
6、.................................................................................................83.4風(fēng)險管理計劃.........................................................................................................................................83.5風(fēng)險管理文檔..................................
7、.......................................................................................................94風(fēng)險分析.........................................................................................................................................................94.1風(fēng)險分析過程
