1、目的


                                                                                                                                                               


通過對本公司醫療器械產品的分類，以便合理地選擇CE符合性認證的途徑。


                                                                                                                                                                                     


2、范圍


                                                                                                                                          


本程序規定進行產品分類的職責、工作程序、內容和要求。


                                                                                                                                                                              


本程序適用于本公司生產的一次性使用醫療器械的產品分類。


                                                                                                                    


3、職責


                                                                                                                                          


3.1技術部負責實施對產品進行分類。


                                                                                                                                                                                  


                                                                                                                                                                      


4、控制程序


                                                                                                                                          


4.1依據MDD93/42/EEC附錄IX的要求，根據產品的預期用途，對擬帶有CE標志的產品進行分


類。              


                                                                                                                            


4.2分類的依據：


                                                                                                                                                                                  


4.2.1 使用時間                                                                                                                                                       


a)“暫時”：指連續使用不超過60分鐘的時間；                                                                                                                                                                  


b)“短期”：指連續使用不超過30天的時間；                                                                                                                                                                    


c)“長期”：指連續使用超過30天的時間。



 


4.2.2 創傷性：                                                                                                                                             


a）非創傷；                                                                                                                                                                       


b）通過孔徑創傷；                                                                                                                                                                 


c）外科創傷；                                                                                                                                                                     


d）植入創傷。



 


4.2.3 使用部位：                                                                                                                                                     


a）中央循環系統；


b）中樞神經系統；                                                                                                                                          


c）其它地方。



 


4.2.4能量供應：                                                                                                                                                      


a）無源；                                                                                                                                                                         


b）有源。



 


                                                                                                                                                                              


4.3分類準則                                                                                                                                                          


根據器械的預期功能,對照MDD93/42/EEC附錄IX的要求按1-18條規則進行分類：一般分為四類，即：Ⅰ類、Ⅱa類、Ⅱb類、Ⅲ類。


                                                                                                                                                                              


4.4產品分類原則


                                                                                                                                                            


4.4.1 分類準則的應用由器械的預期使用目的決定。


                                                                                                                                                            


4.4.2 如果器械是和其他器械配合使用，分類規則分別適用每種器械，附件則以脫離所從屬的器械后按其自身的用途進行分類。


                                                                                                                                                            


4.4.3 機械附件可以和其他一起使用的器械分開獨自分類。


                                                                                                                                                            


4.4.4 啟動或影響某種器械的軟件與器械本身屬于同一類型。



 


4.4.5 如果幾個規則適用于同一器械，則應使用較高一級分類的最嚴格的規則。


                                                                                                                                                            


4.5分類程序：


                                                                                                                                                            


4.5.1 技術部根據產品預期用途，按照MDD93/42/EEC附錄IX的要求，對產品進行分類。


                                                                                                                                                            


4.5.2 管理者代表對分類文件復核，并作為該產品技術文檔的一部分予以保存。


                                                                                                                                                            


4.5.3 依據MDD93/42/EEC附錄IX18條規則，存在不確定因素時由技術部負責咨詢公告機構確


定產品分類。


                                                                                                                                            


4.5.4 當產品預期用途發生變化時，由技術部進行重新分類，經管理者代表復核后通知公告


機構，按《與公告機構聯系控制程序》執行。



 


5、相關文件


                                                                                                                                          


5.1醫療器械指令MDD93/42/EEC附錄IX


                           


5.2《與公告機構聯系控制程序》YH/QP-28



 


6、相關記錄


                                                                                                                                          


6.1產品分類報告QP25-01