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Introduction to "CE" Marking

 

The "CE Marking" is the manufacturer's or importer's mark of conformity declaring compliance with all applicable directives (Low Voltage, EMC, etc.). The use of the CE marking and Declaration of Conformity is mandatory for most products sold in the EC (European Community). 

Any person (manufacturer or importer) can affix the "CE Marking", and issue the "Declaration of Conformity".


Introduction to European Conformity

The goal of the EU (European Union) is to implement a system that protects the health of consumers and workers, the condition of the merchandise, and the environment.

To accomplish this, a system of EU Laws (Directives) has been established to insure conformity to safety and quality related regulations.

This system provides the basis for the harmonization of standards for product safety, machinery and quality throughout the EU.

The system unifies the assessment process and acceptance in all EU countries, thereby eliminating redundant testing and submission of products to individual countries.


 Steps to the CE marking process

The following 6 steps are necessary prior to affixing the CE marking to a product. A manufacturer can perform these steps by way of "self-declaration" or select a notified/competent body for "voluntary certification".

1) Identify all applicable EU directives and standards for the product in question.

2) Perform the conformity assessment according to the relevant EU standards and
    essential requirements of the directives.

3) Manufacturer corrects any deviations found and incorporates the necessary changes
     into the products and the manufacturing process.

4) Establish a Technical File (test reports, documentation, licenses/certificates, etc.)

5) Prepare and sign the EU Declaration of Conformity (EN 45014).

6) Affix the CE marking to the product.


 The Risk of Non-Compliance in Europe

 

LVD - Low Voltage Directive - 2006/95/EC: If a Member State prohibits a product to be marketed for safety reasons, such as non-conformance with or faulty application of standards, or failure to comply with good engineering practice, the Member State shall immediately inform the other Member States. If CE Marking has been affixed unduly, the manufacturer or importer shall be obliged to make the product comply. Where non-compliance continues, the Member State shall restrict or prohibit its sale, or ensure that the product is withdrawn from the market.

Click here to view the Low Voltage Directive

 

Product Liability Directive - 85/374/EEC: Strict liability on the part of manufacturing and their distributor. There are now only a few defenses: If someone is injured or killed while using a product, the manufacturer/distributor is assumed to be guilty.

Click here to view the Product Liability Directive

 

General Product Safety Directive - 2001/95/EC: Gives Member States Authority to control the safety of products and take the appropriate measures. Sets up a system of rapid exchange of information on defective products at National and Community levels. Information is passed to all Member States and possible publishing in the Official Journal of the EC (negative PR).

Click here to view the General Product Safety Directive

 

 


Sample Declaration of Conformity (EN 45014)

   


 

DECLARATION OF CONFORMITY
 
 

We ......................................................................................................
 (suppliers name)

 ............................................................................................................
 (address)

declare under our sole responsibility that the product

.............................................................................................................
 (name, type or model, lot, batch or serial number, possibly
 sources and numbers of items)

 to which this declaration relates is in conformity with the
 following standard(s) or other normative document(s)

 .............................................................................................................
 (title and/or number and date of issue of the standard(s)
 or other normative document(s))

(if applicable) following the provisions of .............. Directive
 
 

............................................                   .........................................
(Place and date of issue)            (name and signature or
                                                         equivalent marking of
                                                          authorized person)