醫(yī)療器械軟件產(chǎn)品注冊標(biāo)準(zhǔn)模板

1、1目次目次目次目次................................................................................................................................................................................1前言................................

2、....................................................................................................................................41.范圍范圍.................................................................................

3、...................................................................................42.規(guī)范性引用文件規(guī)范性引用文件........................................................................................................................

4、........................43.分類分類....................................................................................................................................................................43.1術(shù)語與定義術(shù)語與定義...........

5、.........................................................................................................................................43.2管理分類管理分類.......................................................................

6、.................................................................................43.3命名與型號命名與型號.............................................................................................................................

7、.......................43.4組成組成................................................................................................................................................................54.要求要求......................

8、..............................................................................................................................................54.1產(chǎn)品說明要求產(chǎn)品說明要求..............................................................

9、..................................................................................54.1.1可用性.................................................................................................................................

10、......................54.1.2內(nèi)容...........................................................................................................................................................54.1.3標(biāo)識和標(biāo)示........................

11、.......................................................................................................................54.1.4功能性陳述..........................................................................................

12、.....................................................64.1.4.1功能概述............................................................................................................................................64.1.4.1.1遠(yuǎn)程會診系

13、統(tǒng)................................................................................................................................64.1.4.1.2雙向轉(zhuǎn)診系統(tǒng)...........................................................................

14、...................錯(cuò)誤！未定義書簽。錯(cuò)誤！未定義書簽。4.1.4.1.3計(jì)費(fèi)系統(tǒng)......................................................................................................錯(cuò)誤！未定義書簽。錯(cuò)誤！未定義書簽。4.1.4.1.4醫(yī)療資源共享系統(tǒng).................................

15、.....................................................錯(cuò)誤！未定義書簽。錯(cuò)誤！未定義書簽。4.1.4.1.5管理系統(tǒng)......................................................................................................錯(cuò)誤！未定義書簽。錯(cuò)誤！未定義書簽。4.1.4.2產(chǎn)品的功能....

16、.....................................................................................................................................64.1.4.3當(dāng)有軟件組件的選項(xiàng)和版本時(shí)，應(yīng)指明。.............................................................

17、.......................64.1.4.4功能性限制......................................................................................................錯(cuò)誤！未定義書簽。錯(cuò)誤！未定義書簽。4.1.4.5對未授權(quán)訪問的預(yù)防措施..............................................

18、..................................................................64.1.5可靠性陳述...............................................................................................................................................

19、74.1.6易用性陳述...............................................................................................................................................74.1.7效率陳述........................................................

20、...........................................................................................74.1.8維護(hù)性陳述......................................................................................................................

21、.........................74.1.9可移植性陳述...........................................................................................................................................74.2用戶文檔集要求用戶文檔集要求..........................

22、..................................................................................................................74.2.1完備性.................................................................................................

23、......................................................74.2.2正確性.......................................................................................................................................................84.2.3

24、一致性.......................................................................................................................................................84.2.4易理解性........................................................

25、...........................................................................................837.1標(biāo)志標(biāo)志........................................................................................................................

26、......................................127.2使用說明書使用說明書..................................................................................................................................................128.包裝、運(yùn)輸、儲存包裝、運(yùn)輸、儲存.

27、................................................................................................................................................138.1包裝包裝...................................................................

28、...........................................................................................138.1.1產(chǎn)品應(yīng)有能防潮、防震、保證產(chǎn)品不受自然損壞的包裝。.............................................................138.1.2包裝盒內(nèi)應(yīng)有以下內(nèi)容：..................

29、...................................................................................................138.2運(yùn)輸、儲存運(yùn)輸、儲存..........................................................................................................