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1.CE mark should be marked? A: The CE wordin the CE mark should be in accordance with the provisions of the proportion ofthe minimum height of 5mm, can be affixed to the product or packaging, color.Need to participate in the European Notified Body products, in addition to theCE mark Notified Body”s company code (such as CSI (0497), ISET (0865)). 2. Is there anyCE mark on my product? A: Many EuropeanDirectives on product safety have the so-called New Approach Directive. Theproducts covered by these directives must all be CE certified. There arecurrently about 20 such directives as Low Voltage (LVD) instruction, theelectromagnetic compatibility (EMC) instruction, the medical product (MDD)instruction and so on. 3.CE mark inthose European countries is necessary? A: The EU memberstates are all subject to the CE mark. At present, the member states areAustria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy,Luxembourg, the Netherlands, Portugal, Spain, Sweden and the United Kingdom.Non-EU countries in the European Economic Area also have mandatory CE markingrequirements, such as Norway, Iceland and Liechtenstein. 4.CE signsmandatory countries currently have those? A: At present,there are 18 countries that enforce the European Economic Area (EEA), of which10 are from EU countries (including E1005 in this column) and 10 new countriesare joining on December 12, 2002, indicating that these 10 new countries At thestart of the CE marking, it is stipulated that Cyprus, Maltese in 10 countriessuch as Hungary, Poland, the Czech Republic, Slovakia, Slovakia, Latvia,Lithuania, Estonia and southern Europe will be discussed in Eastern Europe in2004 In 2007, Bulgaria and Romania will be joined. 5. What are theEU directives that medical devices need to meet? A: ImplantableMedical Device Directive (AIMDD, 90/385 / EEC) MedicalDevice Directive (MDD, 93/42 / EEC) In VitroDiagnostic Equipment Directive (IVDD, 98/79 / EC) 6. What is theclassification of medical devices in the United States and Europe? US FDA accordingto the low risk of medical equipment is divided into: Class Ⅰ, Ⅱ, Ⅲ 3 categories Class Ⅰ products only need to register Class Ⅱ products must be cleared 510K recognized Class Ⅲ products, to apply for PMA approval Europe will bedivided into three types of medical equipment 6, that is Class Ⅰ in general, Class Ⅰ measurement functions, Class Ⅰ disinfection requirements, Class Ⅱ a, Class Ⅱ b, Class Ⅲ, to Before the CEmark affixed to the first 4 can be self-declared, but the production process inaddition to the first level must have the EU Notified Body supervision. 7. Medicalequipment in Europe to meet those technical standards? The technicalstandards to be considered are roughly the same SafetyEN60601 (MDD) and EN61010 (IVD) categories Electromagneticcompatibility EN60601-1-2 BiocompatibilityISO10993-1 RiskAnalysis ISO14971 SoftwareEN60601-1-4 8. What is theENEC logo? ENEC is theEuropean Norms Electrical Certification alphanumeric code, which is tested andapproved by the European CCA Member State Testing Organization and accepted byEU, EFTA and most Eastern European countries. At present, ENEC is suitable forlamps, lamp caps, transformers, information products and so on. One afteranother to expand, not limited to manufacturers can apply for country, comparedwith the CB system, its advantages are: not only in many countries common andobvious certification mark, do not have to go to convert a variety ofcertification mark. 9. Whodetermines the validity of the CE certificate? Most electricaland electronic products can be affixed with the CE certification mark as longas they meet the LVD directive and the EMC directive. Moreover, the first ofthe eight certification schemes, namely the self-declaration scheme, can beadopted. Because of this,produced a wide range of CE certification bodies and CE certificates, how toconfirm that the certificate can be accepted by Europe? First of all, shouldunderstand the CE certification system is often overlooked by the basicprinciples of business: If the CE markedproduct does not meet the European technical requirements, it is up to the businessor importer to take responsibility (ie, who gets it for sale in the market andwho is responsible for the product), not the third party (intermediary or testcertification body) . Enterprises donot understand their responsibility in the CE certification process, that theCE certificate was unimpeded, this misunderstanding is some irregularthird-party agencies (intermediaries or testing and certification bodies) spamCE certificate, misleading Caused by the enterprise 10. What is theprimary responsibility of the third party (intermediary or test certificationbody) in CE certification? In the case of aself-declared CE certification model, a corporate representative must sign aself-declaration, and the self-declaration must be accompanied by TechnicalConstruction Files-TCF, including test reports, circuit diagrams, key partcertificate lists, product features Introduction and so on. The primaryresponsibility of a third party (intermediary or testing certification body) isto test the business, assist the company with the completion of technical data(TCF), save ten years with TCF, and require third parties (intermediaries ortest certification bodies ) Be knowledgeable about product performance,European standards including European regulations, and high technicalcapabilities of third parties (intermediaries or testing and certificationbodies). 11. There areseveral types of CE certificate? The currentcommon CE certificate has the following: Declaration ofconformity / Declaration of compliance “Declaration of conformity” This certificateis a self-declaration and should not be issued by a third-party agency (agencyor test certification body). Therefore, it can be replaced by the EU”sDeclaration of Conformity. Certificate ofcompliance / Certificate of compliance “Certificate of Compliance” This is adeclaration of conformity issued by a third party (intermediary or testing andcertification body) and must be accompanied by a technical report TCF, such asa test report. At the same time, the company must also sign the Declaration ofConformity EC Attestationof conformity “EU standard certificate of conformity” This is acertificate issued by the Notified Body abbreviated as NB, and only NBs areeligible to issue EC Type Declaration of CE according to EU regulations. 12. Three kindsof certificates are valid? If you do notuse self-declaration, but by the EU Notified Body (NB) test and issue acertificate, the business does not need to issue “self-declaration”by the “designated agency” for product compliance, by the lawprotection. Therefore, thereis no issue of validity of the CE certificate issued by the Notified Body NB.However, for the issuance of a CE certificate by a third-party agency(intermediary or test certification body), the validity of the CE certificateis determined by the enterprise or the purchaser based on the accuracy andcompleteness of the data and, in the final analysis, the third-party agencyCertification body) technical competence and credibility. In general,laboratories accredited by the European Laboratory Accreditation Body or CNALunder ISO / IEC 17025 are the most trustworthy and even customer-requested. 13. Can a CEissued a separate certificate issued by the directive? Products onlyfully meet the relevant directives CE, third-party agencies (intermediaries ortesting and certification bodies) can issue a certificate of compliance. Somethird-party agencies (intermediaries or test certifiers) do not have the EMCtest capability and therefore only testing compliance with LVD directives andthen issuing CE-marked certificates is a mistake as it may result in”products meeting CE Requirements “, in which case the third-partyagency (intermediary or test certification body) can only issue a CEcertificate without a CE marking and states:” Only LVD directives are evaluatedfor conformance and other relevant directives are supplemented Compliancejudgment “, or only issued a test report, as a technical basis forself-declaration by the enterprise. Companies can re-EMC test in another EMCtesting laboratory, to confirm compliance with EN standards, the company signedthe “Declaration of Conformity.”


1.CE標誌應如何標示? A:CE 標誌中 CE 二字應符合規定比例,高度最少要 5mm,可以貼在產品上或包裝上,顏色不拘。須要歐洲 Notified Body 參與之產品,在CE 標誌旁須加上 Notified Body 之公司代號 ( 如 CSI(0497),ISET(0865) )。 2.我的產品是否要貼CE標誌? A:歐洲議會公告的眾多產品安全指令 ( Directive ) 內,有所謂 New ApproachDirective,此類指令所涵蓋的產品都必須用 CE 標誌來證明符合規定,目前有大約 20 條此類指令,如低電壓 ( LVD ) 指令,電磁兼容性 ( EMC ) 指令,醫療產品 ( MDD ) 指令等。 3.CE標誌在那些歐洲國家是必須的? A:歐盟會員國均適用 CE 標誌規定,目前會員國有奧地利、比利時、丹麥、芬蘭、法國、德國、希臘、愛爾蘭、義大利、盧森堡、荷蘭、葡萄牙、西班牙、瑞典、英國等。歐洲經濟區內的非歐盟國家也有強制 CE 標示規定,如挪威、冰島、列支敦士敦。 4.CE標誌強制國家目前有那些? A:目前強制 CE 的有歐洲經濟區 ( EEA ) 的 18 個國家,其中歐盟國家除原 15 國 ( 參考本專欄 E1005 ) 外,在 2002.12.13 通過 10 個新國家加入,表示此 10 個新國家開始要適用 CE 標誌、規定,10 個國家為東歐的匈牙利、波蘭、捷克、斯洛伐尼亞、斯洛伐克、拉脫維亞、立宛陶、愛沙尼亞、及南歐的塞浦路斯及馬爾它,在 2004 年將討論土耳其之加入,2007 年將討論保加利亞及羅馬尼亞之加入。 5.醫療器材須要滿足的歐盟指令有那些? A: 可植入醫療器材指令(AIMDD,90/385/EEC) 醫療器材指令 (MDD,93/42/EEC) 體外診斷器材指令 (IVDD,98/79/EC) 6.美國及歐洲對醫療器之分類為何? 美國FDA將醫療器材依風險低至高分成: ClassⅠ、Ⅱ、Ⅲ 3類 ClassⅠ 產品只須列名登記 ClassⅡ 產品須申清510K認可 ClassⅢ 產品,須申請PMA認可 歐洲將醫療器材分成3類6級,即 ClassⅠ一般,ClassⅠ有量測功能,ClassⅠ有消毒須求,ClassⅡa、ClassⅡb、Class Ⅲ,要 貼CE標誌時前4級可自我宣告,但生產製程除了第1級外都須有歐盟Notified Body監督。 7.醫療器材在歐洲須符合那些技術標準? 須考慮的技術標準大致為 安全性 EN60601 ( MDD ) 及 EN61010 ( IVD )類 電磁兼容性 EN60601-1-2 生物兼容性 ISO10993-1 風險分析 ISO14971 軟體 EN60601-1-4 8.什麼是ENEC標誌? ENEC 是 European Norms Electrical Certification 的字母編號,由歐洲 CCA 會員國測試機構測試後授權使用並被 EU,EFTA及多數東歐國家所接受,目前適用產品有燈具、燈頭、變壓器、資訊產品等,以後會再陸續擴充,不限製造廠商國別均可提出申請,與 CB 制度相比較其優點為:不但可在多國通用且有明顯之認證標誌,不須再去轉換多種認證標誌。 9.誰確定CE證書的有效性? 大多數電子電器產品只要滿足LVD指令和EMC指令就可以加貼CE認證標誌,而且,可以採用八種認證方式中的第一種,即:自我聲明方式。 正因為如此,產生了各種各樣的CE認證機構和CE證書,如何確認該證書能否被歐洲接受?首先,應瞭解CE認證制度中常被企業忽略的根本原則: 如果貼CE標誌的產品不符合歐洲技術要求,要由企業或進口商承擔責任(即誰拿到市場上銷售,誰對產品負責),而不是由第三方機構(仲介或測試認證機構)承擔責任。 企業對自己在CE認證過程中應承擔的責任不瞭解,以為拿了CE證書就暢通無阻了,這種錯誤認識是一些不正規的第三方機構(仲介或測試認證機構)濫發CE證書、誤導企業所造成的。 10.第三方機構(仲介或測試認證機構)在CE認證中的主要責任是什麼? 如果是自我聲明的CE認證模式,企業法人代表必須簽署一份自我聲明書,而自我聲明書必須附上技術資料(TechnicalConstruction Files—TCF),包括測試報告,電路圖,關鍵件證書清單,產品功能介紹等。 第三方機構(仲介或測試認證機構)的主要責任是為企業進行測試,還可以協助企業完成技術資料(TCF),TCF要保存十年,而整理TCF則要求第三方機構(仲介或測試認證機構)對產品性能、歐洲標準包括歐洲法規都要非常瞭解,對第三方機構(仲介或測試認證機構)的技術能力要求很高。 11.有幾種類型的CE證書? 目前常見的CE證書有以下幾種: Declaration ofconformity / Declaration of compliance《符合性聲明書》 此證書屬於自我聲明書,不應由第三方機構(仲介或測試認證機構)簽發,因此,可以用歐盟格式的企業《符合性聲明書》代替。 Certificate ofcompliance / Certificate of compliance《符合性證書》 此為第三方機構(仲介或測試認證機構)頒發的符合性聲明,必須附有測試報告等技術資料TCF,同時,企業也要簽署《符合性聲明書》 EC Attestationof conformity 《歐盟標準符合性證明書》 此為歐盟公告機構(Notified Body簡寫為NB)頒發的證書,按照歐盟法規,只有NB才有資格頒發EC Type的CE聲明。 12.三種證書是否都有效? 如果不採用自我聲明方式,而是由歐盟公告機構(Notified Body簡寫為NB)測試和出具證書,則企業不需要簽發《自我聲明書》,由“指定機構”對產品符合性承擔責任,受法律保護。 因此,對於歐盟公告機構(Notified Body簡寫為NB)頒發的CE證書,不存在判定有效性的問題。但是,對於第三方機構(仲介或測試認證機構)頒發CE證書,就要由企業或者採購方確定CE證書有效性,依據是資料的準確性和完整性,歸根到底是第三方機構(仲介或測試認證機構)的技術能力和信譽。 通常,獲得歐洲實驗室認可機構或中國試驗室國家委員會(CNAL)按ISO/IEC17025認可的試驗室是最具有可信任度的,甚至是客戶要求的。 13.可否只就某個指令單獨出具CE證書? 產品只有完全滿足CE各相關指令,第三方機構(仲介或測試認證機構)才可以頒發符合性證書。有些第三方機構(仲介或測試認證機構)沒有EMC的測試能力,因此,只對LVD指令的符合性進行測試,然後頒發有CE標記的證書,這是錯誤的,因為這可能造成“產品符合CE要求”的誤導,這種情況下第三方機構(仲介或測試認證機構)只能出具沒有CE標識的CE證書,並說明:“僅對LVD指令進行了符合性判斷,還要補充其他相關指令的符合性判斷”,或者只出具測試報告,作為企業進行自我聲明時的技術依據。企業可以在另外一個有EMC測試能力的試驗室再進行EMC測試,確認符合EN標準要求時,企業自己簽署《符合性聲明書》。

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