CE認(rèn)證所需要提供的資料：

1、制造商（歐盟代表（歐盟代理）AR）的名稱，商號(hào)，地址；

2、產(chǎn)品的型號(hào)，編號(hào)；

3、產(chǎn)品使用說(shuō)明書；

4、安全設(shè)計(jì)文件（關(guān)鍵結(jié)構(gòu)圖，即能反映爬申距離、間隙、絕緣層數(shù)和厚度的設(shè)計(jì)圖）；

5、產(chǎn)品技術(shù)條件（或企業(yè)標(biāo)準(zhǔn)）；

6、產(chǎn)品電原理圖；

7、產(chǎn)品線路圖；

8、關(guān)鍵元部件或原材料清單；

9、測(cè)試報(bào)告(Testing Report）；

10、歐盟認(rèn)證機(jī)構(gòu)NB出具的相關(guān)證書（對(duì)于模式A以外的其它模式）；

11、產(chǎn)品在歐盟境內(nèi)的注冊(cè)證書（對(duì)于某些產(chǎn)品比如：Class I醫(yī)療器械，普通IVD體外診斷醫(yī)療器械）；

12、CE符合聲明（DOC）。

消毒盒CE認(rèn)證辦理流程：

1.企業(yè)向機(jī)構(gòu)提交辦理CE認(rèn)證的申請(qǐng)表，提供產(chǎn)品的資料并寄樣；

2.機(jī)構(gòu)根據(jù)企業(yè)提供的資料來(lái)判定產(chǎn)品對(duì)應(yīng)的歐盟指令和測(cè)試標(biāo)準(zhǔn)，測(cè)試周期以及費(fèi)用；

3.企業(yè)確認(rèn)報(bào)價(jià)后，簽訂技術(shù)服務(wù)合同并支付費(fèi)用；

4.機(jī)構(gòu)工程師根據(jù)歐盟檢測(cè)標(biāo)準(zhǔn)對(duì)產(chǎn)品進(jìn)行整套測(cè)試及相關(guān)型號(hào)的差異性測(cè)試，然后編寫技術(shù)文檔（TCF），提交歐盟機(jī)構(gòu)審核；

5.審核通過(guò)，頒發(fā)CE證書。ta:image/png;base64,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") center center no-repeat; display: inline-block; vertical-align: top;">