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CE认证-CE certification

CE认证标志
CE certification mark


“CE”标志是一种安全认证标志,被视为制造商打开并进入欧洲市场的护照。CE代表欧洲统一(CONFORMITE EUROPEENNE)。凡是贴有“CE”标志的产品就可在欧盟各成员国内销售,无须符合每个成员国的要求,从而实现了商品在欧盟成员国范围内的自由流通。
“CE” mark is a safety certification mark, which is considered the passport to open and enter the European market. CE represents the European unity (CONFORMITE EUROPEEN), and the products posted “CE” mark, which needn’t to be complied with the require of every EU member, can be sold in domestic of EU member states, this means the commodities with “CE” mark are circulated freely in area of EU member states.


在欧共体1985年5月7日的(85/C136/01)号《技术协调与标准的新方法的决议》中对需要作为制定和实施指令目的"主要要求"有特定的含义,即只限于产品不危及人类、动物和货品的安全方面的基本安全要求,而不是一般质量要求,协调指令只规定主要要求,一般指令要求是标准的任务。产品符合相关指令有关主要要求,就能加附CE标志,而不按有关标准对一般质量的规定裁定能否使用CE标志。因此准确的含义是:CE 标志是安全合格标志而非质量合格标志。
“Main demand” for the purpose of making and implementing directive has a specific meaning in the EC May 7, 1985 (85/C 136/01) The Resolution of Technical Coordination and New Method of Standard, which is only restricted to the basic safety requirements of the products not endanger human, animal and goods on security but not the general quality requirements; the coordination directives only rule the main requirements, and the standard task is the requirement of general directives. The products complied with the main requirements of relevant instructions can attach CE mark, but not decided by rules of the relevant standard requirements. Therefore the accurate meaning of CE is: CE mark is safe and qualified symbol rather qualified mark.


CE认证-模式
CE certification modes


目前,欧盟认可的使用CE标志的模式有如下八种:
At present, there are eight kinds of CE marking modes recognized by the EU following:


工厂自我控制和认证
Factory self control and certification
Module A(内部生产控制)
Module A ( internal production control )  
用于简单的、大批量的、无危害产品,仅适用应用欧洲标准生产的厂家。
For simple, large quantities of products, no harm, only for application of European standards for manufacturers.  
工厂自我进行合格评审,自我声明。
Factory self qualification review, self declarations.   
技术文件提交国家机构保存十年,在此基础上,可用评审和检查来确定产品是否符合指令,生产者甚至要提供产品的设计、生产和组装过程供检查。
Technical documents have been submitted to the national body for ten years, on the basis of this, which can be reviewed an inspected to determine whether the products meet the producer instruction, even the producer shall provide product design, production and assembly process for inspection.   


不需要声明其生产过程能始终保证产品符合要求。
No need to declare the production process can always ensure that the products conform to requirements.
Module Ab   
Module Ab


厂家未按欧洲标准生产。
Manufacturer doesn’t keep the European standards for producing.   


测试机构对产品的特殊零部件作随机测试。
Testing agencies do random testing for the special parts of products. 


由测试机构进行评审
Products shall be reviewed by testing agencies.


Module B(EC型式评审)
Module B ( EC pattern review )  


工厂送样品和技术文件到它选择的测试机构供评审,测试机构出具证书。
The factory sends samples and technical documents to the testing agency for review, and testing agencies issue a certificate.   


注:仅有B不足于构成CE的使用。
Note: Only B is insufficient to constitute the use of CE.


Module C(与型式[样品]一致)+B   
Module C (consistent with pattern [sample] )+B


工厂作一致性声明(与通过认证的型式一致),声明保存十年。
The factory makes a conformance statement (consistent with the authentication type), which shall be preserved for ten years.


Module D(生产过程质量控制)+B:  
Module D (production process quality control) + B 


本模式关注生产过程和最终产品控制,工厂按照测试机构批准的方法(质量体系,EN29003)进行生产,在此基础上声明其产品与认证型式一致(一致性声明)。
The model shows solicitude for the production process and final control of product, and factory produces in accordance with the methods (quality system, EN29003) approved by testing agencies, based on the statement of the products conforming to certification patterns (conformance claim).


Module E(产品质量控制)+B  
Module E (products quality control) +B 


本模式仅关注最终产品控制(EN29003),其余同Module D。
The final product control (EN29003) is only concerned by the pattern with the rest of Module D.


Module F(产品测试)+B  
Module F (product test) +B 


工厂保证其生产过程能确保产品满足要求后,作一致性声明。认可的测试机构通过全检或抽样检查来验证其产品的符合性。测试机构颁发证书。
Factory makes the conformance statement after guaranteeing the production process to ensure that products meet the requirements. Accredited test institutions through full inspection and sampling inspection to verify the conformity of the products. Testing agencies award the certificate.


Module G(逐个测试) 工厂声明符合指令要求,并向测试机构提交产品技术参数,测试机构逐个检查产品后颁发证书。
Module G (test one by one)
Factory statement needs meet the requirements of instructions, and factory submits product technical parameters. Testing agencies award certificates after checking products one by one.


Module H(综合质量控制)本模式关注设计、生产过程和最终产品控制(EN29001)。其余同Module D + Module E。其中,模式F+B,模式G适用于危险度特别高的产品。
Module H (integrated quality control)
The pattern is focused on the design, production process and final product control (EN29001) with the rest of Module D + Module E. Wherein, model F + B, model G are suitable for the products with the high risk.


CE认证-流程
CE certification process


此流程适用于厂商找第三方实验室申请CE认证的流程:  
This procedure applies to manufactures to find third party lab to apply for CE certification: 


制造商相关实验室(以下简称实验室)提出口头或书面的初步申请。
The oral or written request made by manufacturer laboratory (hereinafter referred to as the laboratory).   


申请人填写CE-marking申请表,将申请表,产品使用说明书和技术文件一并寄给实验室(必要时还要求申请公司提供一台样机)。
Applicant fills the CE-marking application form, and sends the application form, product instruction and technical document to laboratory ( if necessary also ask applicants to provide a prototype).   


实验室确定检验标准及检验项目并报价。
Laboratory confirms the inspection standards and inspection items, and quotes to applicants.

 
申请人确认报价,并将样品和有关技术文件送至实验室。
The applicants confirm the quotation, and send the samples and relevant technical documents to the laboratory.   


申请人提供技术文件。
The applicants provide technical documents.   


实验室向申请人发出收费通知,申请人根据收费通知要求支付认证费用。
The laboratory issues a charge circular to the applicants, and applicants pay the costs of certification according to the charge notification requirements.


实验室进行产品测试及对技术文件进行审阅。
The laboratory conducts products testing and review the technical documents.  


技术文件审阅包括:
Technical documents review includes:   


a文件是否完善。
Whether the document is perfect or not   


b文件是否按欧共体官方语言(英语、德语或法语)书写。  
Whether the file is written according to the EC official languages (English, German or French) 


如果技术文件不完善或未使用规定语言,实验室将通知申请人改进。
The laboratory will notify the applicant to improve if the technical documents are inadequate or not used in the specified language.   


如果试验不合格,实验室将及时通知申请人,允许申请人对产品进行改进。如此,直到试验合格。申请人应对原申请中的技术资料进行更改,以便反映更改后的实际情况。
If the test is failed, the laboratory will promptly notify the applicant and allow the applicant to improve the product. So, until the test result is qualified. The applicants should make changes for the technical information in the original application form in order to reflect the changed circumstances.


第9、10条所涉及的整改费用,实验室将向申请人发出补充收费通知。
Rectification cost involved in sections 9, 10, the laboratory will issue the applicant with notice of supplementary charges.  


申请人根据补充收费通知要求支付整改费用。   
The applicants pay the rectification cost according to the notice of supplementary char
实验室向申请人提供产品测试报告或技术文件(TCF),以及CE符合证明(COC),及CE标志。
The laboratory provides the products testing report or technical file (TCF), and CE certificates of conformity (COC), and CE mark for applicants.   
申请人签署CE保证自我声明,并在产品上贴附CE标示。
The applicants signs CE to ensure the self-declaration, and attach the CE marks to the products.
建立技术文件及其维护与更新
Create, maintain and update technical documentation
(Technical Files)   欧盟法律要求,加贴了CE标签的产品投放到欧洲市场后,其技术文件(Technical Files)必须存放于欧盟境内供监督机构随时检查。技术文件中所包涵的内容若有变化,技术文件也应及时地更新。
(Technical Files) The EU legal demands that the technical files must be stored within the European Union for the oversight body to check at any time when the products affixed the CE mark and released to European market. The technical files should also be updated if the contents in the technical files changes.


技术文件通常应包括下列内容:  
The technical files should normally include the following: 
A. 制造商(欧盟授权代表(欧盟授权代理)AR)的名称,商号,地址。
The name, trade name, address of the manufacturer (EU authorized representative (EU authorized agent) AR),  
B. 产品的型号,编号。
Product model and number.  
C. 产品使用说明书。
Product instruction manual.  
D. 安全设计文件(关键结构图,即能反映爬申距离、间隙、绝缘层数和厚度的设计图)。
Safety designing documents (key structure diagram that reflects the creeping distances, clearances, insulating layers and the thickness for the design).
E. 产品技术条件(或企业标准)。
Products technical conditions (or enterprise standards).
F. 产品电原理图。
Products circuit diagram.   
G. 产品线路图。
Products roadmap. 
H. 关键元部件或原材料清单。
Key components or raw materials inventory.  
I. 测试报告 (Testing Report)。  
Testing Report.
J. 欧盟授权认证机构NB出具的相关证书(对于模式A以外的其它模式)。
EU Notified Body NB issued the relevant certificates (for other modes outside the mode A)
K. 产品在欧盟境内的注册证书 (对于某些产品比如:Class I 医疗器械,普通IVD体外诊断医疗器械)。
Registration certificate of products within the European Union (for some products, such as: Class I medical devices, ordinary IVD in vitro diagnostic medical devices). 
L. CE符合声明(DOC)。
Declaration of CE compliance (DOC).

 

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