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CE Certification

CE Certification
 
First,what is the CE mark?
In recent years,more and more CE certification marks have been used among the selling goods of the European economic zone,such as European Union and European Free Trade Association,
except Switzerland.The commodities that labeled with CE marks are meant to be conformed to safety,health,environmental protection and consumer protection etc. European directives.
 
Second,what does CE represent?
In the past,European Communities have different requirements on import and selling products.
Some product accords to one country`s standards,but it may not be listed in other countries.As part of efforts to eliminate trade barriers,CE certification emerged as the times require.Therefore,CE represents CONFORMITE EUROPEENNE.As a matter of fact,CE is short for European Community,which appeared in many national languages in ec countries.In early time,EC is the abbreviation of European Community,and then it is COMMUNATE EUROPEIA in French,COMUNITA EUROPEA in Italian,COMUNIDADE EUROPEIA in Portuguese,COMUNIDADE EUROPE in Spanish,as a result,EC was changed to CE.However,we might as well think of CE as CONFORMITY WITH EUROPEAN (DEMAND).
 
Third,what is the significance of CE mark?
The significance of CE mark is as follows:
1. Using CE abbreviation as the symbol means that products labeled with CE mark meet the essential requirements of European directives.
2. To confirm that the product has passed the corresponding conformity assessment procedures and/or manufacturer's qualification statement.
3. Becoming the passport of product`s entering the European Community market.
If relevant directives require some product must be labeled with CE mark,but the product has no,it shall not be marketed.The products labeled with CE mark and already entered the market,if they are found not complying with the safety requirements,they must be withdraw from the market.If the products continue violating the relevant directives of CE mark,they will be restricted or banned from entering the European market or forced to withdraw from the market.
 
Fourth,whether CE mark has the meaning of quality conformance?
The core of European directive------Essential Requirements,the (85/C136/01)Resolution of new methods of technical coordination and standards issued on 7,May,1985 has a specific meaning on Essential Requirements,which is limited to do not endanger the basic safety requirements of human,animal,and products,rather than the general quality requirements.Coordination directive only sets main requirements,while general directive determines the standards.If products comply with relevant directives and essential requirements,they can be labeled with CE mark.,not decided by relevant standards on the general quality.Therefore,the accurate meaning is: CE mark is safety approval mark rather than quality approval mark.
A kite with CE mark does not mean that it can fly well,but that it only complies with safety regulations.
 
Fifth,CE mark is suitable for what kind of products?When was it put into effect?
According to statistics in December1997,European Community issued and implemented directives of CE mark were as below,listing the Product,Directive Title,CE Ref. and Entry Into Force:
Directive Title CE Ref. Entry Into Force
Simple Pressure-vessels 87/404/EEC   1.7.1992
Toys 88/378/EEC   1.1.1990
Construction Products 89/106/EEC   27.6.1991
Electromagnetic Compatibility 89/336/EEC 1.1.1992 1.1.1996
Machines 89/392/EEC as amended 1.1.1993 1.1.1995
Personal Protective Equipment 90/686/EEC as amended   1.7.1995
Non-automatic Weighing Machines 90/384/EEC   1.1.1993
Active Implantable Medical Devices 90/385/EEC 1.1.1993 1.1.1995
Medical Devices-general 93/42/EEC 1.1.1995 15.6.1998/4/3
Gas Appliances 90/396/EEC 1.1.1992 1.1.1996
Telecommunications Terminal Equipment 91/263/EEC   6.11.1992
Boilers 92/42/EEC 1.1.1994 1.1.1998
Explosives 93/15/EEC 1.1.1995 1.1.2003
Low Voltage Electrical Products 73/23/EEC modified by 93/68/EEC 1.1.1995 1.1.1997
Satellite Earth Station for Telecommunications 93/97/EEC 1.5.1995 1.5.1997
Lifts Proposal: COM(92)35 COM(93)240Com Pos.25/94 1.1.1998 1.1.2000
Equipment for Use in Explosive Atmospheres 94/9/EC 1.3.1996 1.7.2003
Recreational Craft (Boats) 94/25/EC 16.6.1996 16.6.1998
Non-simple Pressure Vessels Proposal: COM(93)319 1.7.1996 1.1.1999
 
 
Sixth,how to use CE mark when a product is affected by multiple directives at the same time?
When a product is affected by multiple directives at the same time,the product can be labeled with CE mark only after it complies with all relevant regulations.For example,if just making security test,that is,low voltage test, on a energy-saving lamp,it does not constitute sufficient condition for using CE mark.The lamp can be labeled with CE mark only after it complies with both low voltage directives and electro magnetic compatibility.
 
Seventh,what CE mak modules can be chosen by manufactures?
At present,there are following eight kinds of CE mark modules approved by European Community:
First,self control and certification.
Module A----Internal production control
1. Available for simple,mass-produced,and harmless products,only available for European -standard manufacture.
2. Manufacture proceeds self-evaluate and self-declaration.
3. Technical documentation has been preserved by state institution for ten years,and on this basis we can confirm whether the products comply with relevant directives by assessment and examination,manufacture has to offer product design,production process and assembly procedure for inspection.
4. Declaring the production process always ensure products conform to the requirements is not necessary.
Module Ab
1. Manufacture does not produce based on European standards.
2. certified organizations make random testing on special parts of products.
Second,reviewed by certified organizations.
Module B----EC type of review
Manufacture sends samples and technical file to their certified organization for review,and then the institution issues certification.
Note: Only Module B is insufficient to constitute the use of CE.
Module C----Consistent with the pattern/sample+B
Manufacture proceeds a declaration of conformity,in accord with certified model,and keep the declaration for ten years.
Module D----Production Process Quality Control+B
This module focuses on production process control and final products control,manufacture produces according to method(quality system EN29003) approved by certified organization,on this basis they can state that their products are consistent with the certified ones,that is,declaration of conformity.
Module E----Production Quality Control+B
This module only focuses on final products quality control(EN 29003),the others are the same with Module D.
Module F----Product Testing+B
Manufacture make sure that their production process can make their products meet the relevant requirements,on this basis they can do declaration of conformity.While the approved certified organization can verify the conformity of products through full-inspection or sampling inspection.Certification is issued by certified organization.
Module G----Tested one by one
Manufacture declare that their products conform to relevant directives and requirements,and submit product technical parameters to certified organization,and then certified organization can issue certification after they test the products one by one.
Module H----Comprehensive Quality Control
This module focuses on product design,production process and final products control(EN 29001).The others are the same with Module D+Module E.Module F+B and Module G are suitable for particularly high risk products.
 
Eighth,using CE mark needs to pass what legal procedures?
Manufacture can operate according to the following main steps:
1. According to the directives,we need to confirm what kind of assessment module,principles,and directive no. 93/465 / EEC to pass,and select the appropriate module among the eight modules.
2. Adopting self-assessment according to relevant directives,or apply for assessment by a third party,or forced to apply European Community to inform approved certified organization to make assessment,then prepare a statement with manufacture`s self-assessment,or a CE certification issued by approved certified organization as the precondition of using CE mark.
3. According to the regulations of manufacture`s relevant instructions,after passing regulated  pattern of conformity assessment,the manufacture can make or use CE mark and relevant directives additional information themselves.
4. If relevant directives require to add certified organization identification number by the CE mark,the number should be added by certified organization itself,or authorized manufacture,or agent in European Community.As for particularly dangerous products,if the directives regulate that the mandatory approved certified organization must do sampling inspection,the manufacture only has the right to use CE mark after they obtain approved evaluation.
 
Ninth,CE mark accepts which kind of object?
CE mark accepts National Regulatory Authorities,which is responsible for market product safety control,rather than customers.When a product is labeled with CE mark,National Regulatory Authorities shall assume that the product meets essential requirements,and can be sold on the European market.