a)改進(jìn)設(shè)計(jì)。                                                                                                                                               


b)加強(qiáng)安全說明指導(dǎo)。                                                                                                                                                 


c)重新確定預(yù)期用途。


                                                                                                                                  


4.6其它危害的產(chǎn)生


                                                                                                                                                            


確定在降低風(fēng)險(xiǎn)過程中是否會(huì)引起新的危害產(chǎn)生。


                                                                                                                                               


4.7所有已判定危害的評(píng)估


                                                                                                                                                          


若對(duì)所有的危害項(xiàng)都估計(jì)了風(fēng)險(xiǎn)并在可接受水平時(shí)，則可進(jìn)行4.8，否則退回至4.3。                                                                                                                 


4.8風(fēng)險(xiǎn)分析報(bào)告


                                                                                                                                                            


4.8.1 將以上風(fēng)險(xiǎn)分析過程及其結(jié)果的記錄形成風(fēng)險(xiǎn)分析報(bào)告，并作出被分析產(chǎn)品所考慮到


預(yù)期應(yīng)用與已判定危害有關(guān)的剩余風(fēng)險(xiǎn)是否達(dá)到可接受的水平。


                                                                                                                            


4.8.2風(fēng)險(xiǎn)分析報(bào)告應(yīng)有闡明編寫、審核人員簽字。


                                                                                                                                                                                  


4.9風(fēng)險(xiǎn)分析評(píng)審


                                                                                                                                                            


4.9.1當(dāng)有新的資料/數(shù)據(jù)可以應(yīng)用時(shí)，應(yīng)考慮進(jìn)行一次新的風(fēng)險(xiǎn)分析。


                                                                                                                                                                                  


4.9.2隨著時(shí)間的推移，風(fēng)險(xiǎn)有可能發(fā)生變化，新的風(fēng)險(xiǎn)可能出現(xiàn)，有可能再次判定產(chǎn)生新的


危害。


                                                                                                                          


5、相關(guān)文件


                                                                                                                                          


5.1醫(yī)療器械-風(fēng)險(xiǎn)管理對(duì)醫(yī)療器械的應(yīng)用 ISO14971：2000。


                                                                                                                                                                                  


6、相關(guān)記錄


                                                                                                                                          


6.1風(fēng)險(xiǎn)管理報(bào)告QP26-01



 


6.2調(diào)查報(bào)告