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1、ICS11.040.01YYC30中華人民共和國(guó)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(xiǎn)管理對(duì)醫(yī)療器械的應(yīng)用Medicaldevices—Applicationofriskmanagementtomedicaldevices（ISO14971:2007更正版,IDT）（報(bào)批稿）（本稿完成日期：2014-11-15）2016-02-01發(fā)布2017-01-01實(shí)施國(guó)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(yǔ)和定義............................................................................

4、.........................................................................13風(fēng)險(xiǎn)管理通用要求.........................................................................................................................................63.1風(fēng)險(xiǎn)管理過(guò)程..........................................................

5、...............................................................................63.2管理職責(zé).................................................................................................................................................83.3人員資格................................................

6、.................................................................................................83.4風(fēng)險(xiǎn)管理計(jì)劃.........................................................................................................................................83.5風(fēng)險(xiǎn)管理文檔..................................

7、.......................................................................................................94風(fēng)險(xiǎn)分析.........................................................................................................................................................94.1風(fēng)險(xiǎn)分析過(guò)程