c)技術特性；                                                                                                                                               


d)使用、操作方法；                                                                                                                                         


e)警告及使用注意事項；                                                                                                                                               


f)風險分析；                                                                                                                                               


g)廢棄與處理要求。 



 


4.2技術部完成標簽、說明內容的編制后，由技術副總經理對其進行審定，并依據歐盟各國法


定語言的規定要求，對產品的相關內容安排翻譯和校對。


                                                                                                                            


4.3標簽、說明的變更與管理執行《文件控制程序》。


                                                                                                                                                            


4.4最終產品上的標簽、說明及語言形式應符合相關產品的標準要求，質檢部在對最終產品的


標簽、說明內容進行驗證確認后，按《產品監視和測量控制程序》簽發放行。



 


5、相關文件


                                                                                                                                          


5.1醫療器械標簽符號 規定  EN980；


                                                                                                                                                            


5.2醫療器械術語、符號和信息  EN1041：1993；                               

                                                                                                                                              


5.3文件控制程序YH/QP-01


                                                                                                                                                                     


5.4產品監視和測量控制程序YH/QP-20


                                                                                                                                                            


6、相關記錄


                                                                                                                                          


6.1標簽最終確認驗證記錄QP27-01