二(er)(er)(er)手(shou)(shou)(shou)(shou)產(chan)(chan)品(pin)(pin)（如(ru)二(er)(er)(er)手(shou)(shou)(shou)(shou)機械(xie)、二(er)(er)(er)手(shou)(shou)(shou)(shou)**設(she)備）進(jin)口歐(ou)盟(meng)需(xu)滿(man)足CE認(ren)(ren)證(zheng)(zheng)(zheng)合(he)(he)(he)規，流(liu)程與全(quan)新(xin)(xin)產(chan)(chan)品(pin)(pin)略有差異，木亥(hai)心是“狀態評(ping)估-認(ren)(ren)證(zheng)(zheng)(zheng)補充-符(fu)合(he)(he)(he)性(xing)聲明”三步(bu)：首先評(ping)估產(chan)(chan)品(pin)(pin)狀態，確認(ren)(ren)是否有損壞、改裝（如(ru)二(er)(er)(er)手(shou)(shou)(shou)(shou)機床(chuang)是否更換過木亥(hai)心部件）；其次(ci)若產(chan)(chan)品(pin)(pin)已(yi)過CE認(ren)(ren)證(zheng)(zheng)(zheng)有效期(qi)，或有改裝，需(xu)補充測試(shi)（如(ru)二(er)(er)(er)手(shou)(shou)(shou)(shou)機械(xie)需(xu)重新(xin)(xin)做MD指令的風險評(ping)估）；醉(zui)后提交“二(er)(er)(er)手(shou)(shou)(shou)(shou)產(chan)(chan)品(pin)(pin)CE符(fu)合(he)(he)(he)性(xing)聲明”，注明產(chan)(chan)品(pin)(pin)原制造商(shang)、首x次(ci)認(ren)(ren)證(zheng)(zheng)(zheng)時(shi)間、二(er)(er)(er)手(shou)(shou)(shou)(shou)進(jin)口商(shang)信息。某機械(xie)企業(ye)進(jin)口二(er)(er)(er)手(shou)(shou)(shou)(shou)德國數控機床(chuang)時(shi)，因原CE證(zheng)(zheng)(zheng)書過期(qi)（有效期(qi)5年），需(xu)重新(xin)(xin)做MD指令的**評(ping)估，委托實驗(yan)室(shi)測試(shi)耗時(shi)3周(zhou)，額外投入8萬元。企業(ye)需(xu)注意：二(er)(er)(er)手(shou)(shou)(shou)(shou)**設(she)備需(xu)額外符(fu)合(he)(he)(he)MDR/IVDR的“使(shi)(shi)用(yong)前驗(yan)證(zheng)(zheng)(zheng)”要求(qiu)，如(ru)二(er)(er)(er)手(shou)(shou)(shou)(shou)MRI設(she)備需(xu)做性(xing)能校(xiao)準（按EN61311標準），確保**使(shi)(shi)用(yong)。產(chan)(chan)品(pin)(pin)貼上(shang) CE，歐(ou)洲市場任你闖。天津鋼管歐(ou)盟(meng)CE認(ren)(ren)證(zheng)(zheng)(zheng)費用(yong)

出(chu)口歐盟小語(yu)(yu)種**（如德國(guo)、法國(guo)、西班牙(ya)、意(yi)大(da)利(li)(li)），CE認(ren)(ren)證(zheng)(zheng)文檔需(xu)(xu)滿足本地化適配，木(mu)亥心是“語(yu)(yu)言(yan)翻(fan)譯(yi)+公(gong)證(zheng)(zheng)合規(gui)”：語(yu)(yu)言(yan)上(shang)(shang)，產品(pin)(pin)說(shuo)(shuo)明書、警告語(yu)(yu)需(xu)(xu)翻(fan)譯(yi)成(cheng)(cheng)當(dang)地語(yu)(yu)言(yan)（如出(chu)口德國(guo)需(xu)(xu)德語(yu)(yu)，出(chu)口西班牙(ya)需(xu)(xu)西班牙(ya)語(yu)(yu)），翻(fan)譯(yi)內容需(xu)(xu)準確（如技術參數不(bu)可錯(cuo)譯(yi)）；公(gong)證(zheng)(zheng)上(shang)(shang)，部(bu)分**（如法國(guo)、意(yi)大(da)利(li)(li)）要(yao)(yao)求翻(fan)譯(yi)件經(jing)當(dang)地公(gong)證(zheng)(zheng)機構(gou)公(gong)證(zheng)(zheng)（如法國(guo)的(de)Huissierdejustice公(gong)證(zheng)(zheng)），公(gong)證(zheng)(zheng)文件需(xu)(xu)包含翻(fan)譯(yi)員資質證(zheng)(zheng)明。此外，標簽標識也(ye)需(xu)(xu)本地化，如德國(guo)要(yao)(yao)求產品(pin)(pin)標注“Hersteller”（制造(zao)商）、法國(guo)要(yao)(yao)求標注“Fabriquant”。某家具企(qi)業出(chu)口意(yi)大(da)利(li)(li)的(de)沙發(fa)，因說(shuo)(shuo)明書未翻(fan)譯(yi)成(cheng)(cheng)意(yi)大(da)利(li)(li)語(yu)(yu)，被市(shi)場監督機構(gou)處罰(fa)5000歐元，重新印刷說(shuo)(shuo)明書耗時1周。企(qi)業需(xu)(xu)注意(yi)：可委托當(dang)地翻(fan)譯(yi)機構(gou)（如德國(guo)的(de)DEKRA翻(fan)譯(yi)部(bu)）完成(cheng)(cheng)本地化，確保語(yu)(yu)言(yan)合規(gui)，避(bi)免因翻(fan)譯(yi)錯(cuo)誤導致用戶誤解(jie)。天(tian)津(jin)鋼板(ban)歐盟CE認(ren)(ren)證(zheng)(zheng)服(fu)務獲得(de) CE 認(ren)(ren)證(zheng)(zheng)，產品(pin)(pin)踏上(shang)(shang)歐洲(zhou)發(fa)展之路。

歐(ou)(ou)盟CE認證中(zhong)的(de)(de)“化(hua)學(xue)(xue)(xue)物(wu)(wu)質(zhi)(zhi)(zhi)限(xian)(xian)制(zhi)(zhi)”是多個(ge)指(zhi)令(ling)與法規(gui)(gui)的(de)(de)共(gong)同要(yao)求，除REACH法規(gui)(gui)外，還(huan)包括(kuo)POPs法規(gui)(gui)（關(guan)于持久性有機(ji)污染物(wu)(wu)的(de)(de)法規(gui)(gui)）、PFOS法規(gui)(gui)（關(guan)于全(quan)(quan)(quan)氟辛烷磺酸的(de)(de)限(xian)(xian)制(zhi)(zhi)）等(deng)，企(qi)業(ye)(ye)需全(quan)(quan)(quan)偭(mian)把控產(chan)(chan)品(pin)(pin)中(zhong)的(de)(de)化(hua)學(xue)(xue)(xue)物(wu)(wu)質(zhi)(zhi)(zhi)使(shi)用(yong)，避免違(wei)(wei)規(gui)(gui)。REACH法規(gui)(gui)限(xian)(xian)制(zhi)(zhi)高關(guan)注物(wu)(wu)質(zhi)(zhi)(zhi)（SVHC）在產(chan)(chan)品(pin)(pin)中(zhong)的(de)(de)含量(liang)，若產(chan)(chan)品(pin)(pin)中(zhong)SVHC含量(liang)超(chao)過0.1%且每年出口量(liang)超(chao)過1噸(dun)，需向(xiang)歐(ou)(ou)盟化(hua)學(xue)(xue)(xue)品(pin)(pin)管理局通報(bao)；POPs法規(gui)(gui)禁止使(shi)用(yong)滴滴涕(ti)、多氯(lv)聯苯(ben)等(deng)持久性有機(ji)污染物(wu)(wu)，這(zhe)些(xie)物(wu)(wu)質(zhi)(zhi)(zhi)在環(huan)境(jing)中(zhong)難以降解，會危害生態與人體健(jian)康；PFOS法規(gui)(gui)限(xian)(xian)制(zhi)(zhi)全(quan)(quan)(quan)氟辛烷磺酸在產(chan)(chan)品(pin)(pin)中(zhong)的(de)(de)使(shi)用(yong)，如紡(fang)織服(fu)裝(zhuang)的(de)(de)防水處理、涂料(liao)中(zhong)的(de)(de)添加劑等(deng)。企(qi)業(ye)(ye)需建立原材(cai)料(liao)采購管控體系，要(yao)求供應商提供化(hua)學(xue)(xue)(xue)物(wu)(wu)質(zhi)(zhi)(zhi)檢測(ce)報(bao)告，確保原材(cai)料(liao)符合限(xian)(xian)制(zhi)(zhi)要(yao)求；對成品(pin)(pin)進(jin)行抽樣檢測(ce)，驗證化(hua)學(xue)(xue)(xue)物(wu)(wu)質(zhi)(zhi)(zhi)含量(liang)是否達標；在技(ji)術文件中(zhong)記錄化(hua)學(xue)(xue)(xue)物(wu)(wu)質(zhi)(zhi)(zhi)使(shi)用(yong)情況，包括(kuo)種類(lei)、含量(liang)、合規(gui)(gui)證明。若產(chan)(chan)品(pin)(pin)因功(gong)能(neng)需求必須使(shi)用(yong)受限(xian)(xian)化(hua)學(xue)(xue)(xue)物(wu)(wu)質(zhi)(zhi)(zhi)，需提前向(xiang)歐(ou)(ou)盟監(jian)管部(bu)門申請授權，獲(huo)得批準后才能(neng)使(shi)用(yong)，避免因化(hua)學(xue)(xue)(xue)物(wu)(wu)質(zhi)(zhi)(zhi)違(wei)(wei)規(gui)(gui)導致(zhi)產(chan)(chan)品(pin)(pin)無法進(jin)入歐(ou)(ou)盟市場。

CE認(ren)(ren)證技(ji)(ji)術(shu)文(wen)(wen)(wen)件(jian)（TechnicalFile）是合(he)規(gui)(gui)木亥心，需(xu)(xu)按“結構(gou)清晰、內容(rong)完整(zheng)、可追溯”原則編制，不(bu)同指(zhi)令要(yao)求略有差異，但通(tong)用(yong)包含(han)“產(chan)(chan)(chan)品(pin)(pin)標(biao)(biao)識、設(she)計(ji)文(wen)(wen)(wen)檔、測(ce)試(shi)報(bao)告(gao)、符(fu)合(he)性聲(sheng)明”四部分(fen)：產(chan)(chan)(chan)品(pin)(pin)標(biao)(biao)識需(xu)(xu)明確型號(hao)(hao)、規(gui)(gui)格、生(sheng)(sheng)產(chan)(chan)(chan)日期；設(she)計(ji)文(wen)(wen)(wen)檔需(xu)(xu)包含(han)圖紙（如機械產(chan)(chan)(chan)品(pin)(pin)的結構(gou)圖）、材料清單（需(xu)(xu)標(biao)(biao)注(zhu)材料牌號(hao)(hao)及認(ren)(ren)證狀態）；測(ce)試(shi)報(bao)告(gao)需(xu)(xu)由具(ju)備(bei)CNAS或ILAC資(zi)質的實(shi)(shi)驗(yan)室(shi)出具(ju)（如EMC測(ce)試(shi)報(bao)告(gao)需(xu)(xu)符(fu)合(he)EN61000標(biao)(biao)準(zhun)）；符(fu)合(he)性聲(sheng)明（DoC）需(xu)(xu)包含(han)制造商信息、適(shi)用(yong)指(zhi)令、公告(gao)機構(gou)編號(hao)(hao)（如有）。技(ji)(ji)術(shu)文(wen)(wen)(wen)件(jian)需(xu)(xu)保(bao)存(cun)至(zhi)少10年（**設(she)備(bei)需(xu)(xu)保(bao)存(cun)至(zhi)產(chan)(chan)(chan)品(pin)(pin)退市后5年），可采用(yong)電子(zi)形式（需(xu)(xu)加密存(cun)儲，加密等級≥AES-256）。某(mou)電子(zi)企(qi)業因技(ji)(ji)術(shu)文(wen)(wen)(wen)件(jian)缺失“EMC測(ce)試(shi)原始數(shu)據”，CE認(ren)(ren)證審核被暫(zan)停，聯(lian)系實(shi)(shi)驗(yan)室(shi)補開數(shu)據報(bao)告(gao)耗時1周，延誤出貨。企(qi)業需(xu)(xu)注(zhu)意(yi)：技(ji)(ji)術(shu)文(wen)(wen)(wen)件(jian)需(xu)(xu)與(yu)產(chan)(chan)(chan)品(pin)(pin)實(shi)(shi)際(ji)一致，如設(she)計(ji)圖紙版(ban)本需(xu)(xu)與(yu)生(sheng)(sheng)產(chan)(chan)(chan)記(ji)錄版(ban)本匹配，避免“文(wen)(wen)(wen)件(jian)與(yu)實(shi)(shi)物(wu)不(bu)符(fu)”風險。未獲 CE 認(ren)(ren)證，產(chan)(chan)(chan)品(pin)(pin)無法(fa)在歐(ou)盟合(he)法(fa)銷(xiao)售。

CE 認(ren)(ren)證(zheng)(zheng)產(chan)品若發生技(ji)術變(bian)(bian)(bian)更(geng)(geng)(geng)(geng)（如(ru)(ru)材(cai)料(liao)(liao)(liao)更(geng)(geng)(geng)(geng)換(huan)、設計(ji)修改、功能升級），需(xu)(xu)(xu)按 “變(bian)(bian)(bian)更(geng)(geng)(geng)(geng)等級 - 申請流(liu)程 - 驗證(zheng)(zheng)測試(shi)” 三步處理(li)：首先判定變(bian)(bian)(bian)更(geng)(geng)(geng)(geng)等級，輕微變(bian)(bian)(bian)更(geng)(geng)(geng)(geng)（如(ru)(ru)顏色變(bian)(bian)(bian)更(geng)(geng)(geng)(geng)）可自(zi)行(xing)評(ping)估(gu)，無需(xu)(xu)(xu)申請；中度變(bian)(bian)(bian)更(geng)(geng)(geng)(geng)（如(ru)(ru)材(cai)料(liao)(liao)(liao)更(geng)(geng)(geng)(geng)換(huan)）需(xu)(xu)(xu)提(ti)交變(bian)(bian)(bian)更(geng)(geng)(geng)(geng)申請至(zhi)公告(gao)機(ji)構，提(ti)供變(bian)(bian)(bian)更(geng)(geng)(geng)(geng)說(shuo)明、新材(cai)料(liao)(liao)(liao)測試(shi)報告(gao)；重大(da)變(bian)(bian)(bian)更(geng)(geng)(geng)(geng)（如(ru)(ru)木亥心設計(ji)修改）需(xu)(xu)(xu)重新開展符合性(xing)評(ping)估(gu)，相當(dang)于新認(ren)(ren)證(zheng)(zheng)。變(bian)(bian)(bian)更(geng)(geng)(geng)(geng)申請需(xu)(xu)(xu)包含 “原認(ren)(ren)證(zheng)(zheng)證(zheng)(zheng)書編號(hao)、變(bian)(bian)(bian)更(geng)(geng)(geng)(geng)內容、變(bian)(bian)(bian)更(geng)(geng)(geng)(geng)原因(yin)、驗證(zheng)(zheng)數據”，公告(gao)機(ji)構審核周期通常(chang) 1-2 周（重大(da)變(bian)(bian)(bian)更(geng)(geng)(geng)(geng)除外(wai)）。某**企業(ye)生產(chan) IIa 類監護儀時(shi)，因(yin)更(geng)(geng)(geng)(geng)換(huan)顯示屏材(cai)料(liao)(liao)(liao)（從(cong) LCD 改為 OLED），未申請 CE 變(bian)(bian)(bian)更(geng)(geng)(geng)(geng)，被歐盟監管機(ji)構要(yao)求整(zheng)改，補辦變(bian)(bian)(bian)更(geng)(geng)(geng)(geng)申請耗時(shi) 1 周，延誤(wu)產(chan)品更(geng)(geng)(geng)(geng)新。企業(ye)需(xu)(xu)(xu)注(zhu)意：技(ji)術變(bian)(bian)(bian)更(geng)(geng)(geng)(geng)后(hou)需(xu)(xu)(xu)在產(chan)品標(biao)識、技(ji)術文件中體現變(bian)(bian)(bian)更(geng)(geng)(geng)(geng)信息，如(ru)(ru)標(biao)注(zhu) “變(bian)(bian)(bian)更(geng)(geng)(geng)(geng)日期、變(bian)(bian)(bian)更(geng)(geng)(geng)(geng)版本(ben)”，避(bi)免與原認(ren)(ren)證(zheng)(zheng)信息混淆。想在歐洲市(shi)場立(li)足，CE 認(ren)(ren)證(zheng)(zheng)至(zhi)關重要(yao)。天津鋼管歐盟CE認(ren)(ren)證(zheng)(zheng)費用

要進軍歐盟市場(chang)，CE 認(ren)證必不可少。天津(jin)鋼管歐盟CE認(ren)證費用(yong)

《承壓(ya)(ya)(ya)(ya)設(she)備(bei)指令》（PED，2014/68/EU）將(jiang)壓(ya)(ya)(ya)(ya)力容(rong)器、管道等承壓(ya)(ya)(ya)(ya)設(she)備(bei)按“壓(ya)(ya)(ya)(ya)力×容(rong)積”分為(wei)I-IV類(lei)，認證(zheng)流(liu)程隨等級遞(di)增：I類(lei)設(she)備(bei)（如(ru)小型儲氣(qi)罐）可自(zi)我聲明，需(xu)提交設(she)計(ji)(ji)(ji)計(ji)(ji)(ji)算書；II類(lei)設(she)備(bei)需(xu)公告機構(gou)審(shen)核(he)技術文件（如(ru)焊接工藝評定報告）；III類(lei)設(she)備(bei)需(xu)公告機構(gou)介入制造(zao)過程（如(ru)無(wu)損檢測(ce)見證(zheng)）；IV類(lei)設(she)備(bei)（如(ru)大型鍋爐）需(xu)全流(liu)程監督（從原材料檢驗(yan)到(dao)醉終水壓(ya)(ya)(ya)(ya)試驗(yan)）。某機械企業生產(chan)II類(lei)換熱(re)器時，因未按PED要求做水壓(ya)(ya)(ya)(ya)試驗(yan)（壓(ya)(ya)(ya)(ya)力為(wei)設(she)計(ji)(ji)(ji)壓(ya)(ya)(ya)(ya)力的1.5倍，保壓(ya)(ya)(ya)(ya)60分鐘），認證(zheng)失敗(bai)，重(zhong)新測(ce)試導致訂(ding)單延期(qi)2周，賠(pei)償客戶違約(yue)金5萬(wan)元。企業需(xu)注意：PED與ASME認證(zheng)不直接互認，出口歐盟需(xu)單獨申請，可利用EN13445標(biao)準與ASME標(biao)準的兼(jian)容(rong)性(xing)減少重(zhong)復測(ce)試。天(tian)津鋼管歐盟CE認證(zheng)費(fei)用