Product Safety and the Export Challenge
One of the most important markets in the world is the European Economic
Area (EEA) which is comprised of the European Free Trade Association
(EFTA) and the European Union (EU) countries. The EEA with its 380 million
inhabitants is one of the largest and richest markets in the world.
Additionally many countries to the east of the EU are seeking favorite
trade status or even membership in the EU. Therefore these countries must
align their political and economic structures to that of the European
Union. This includes the adoption of directives and standards mandatory in
the EU.
There are Directives regarding Electromagnetic Compatibility (EMC), Low
Voltage equipment, Machinery and Medical Devices that have a major impact
on European and Global industries selling products in this region of the
World. New standards (European Norms) and requirements regarding EMC and
safety must be met to comply with these Directives.
European norms are in general based on or adopted from the
International Electrotechnical Commission (IEC) standards. Approximately
60 member countries create IEC standards with the input of their national
standards working groups and committees. The United States is represented
through the American National Standards Institute (ANSI) and influences a
variety of standards such as IEC 60950, IEC 61010 and IEC 60601. These IEC
standards have been harmonized as European Norms (EN's) with the same
numbers EN 60950, EN 61010, EN 60601 plus very limited European Amendments
to reflect special national conditions.
The CE marking is not directed at consumers but is meant to facilitate
the free movement of goods within the European Union by showing that
products conform to the requirements of directives issued by legislators
in Brussels with their "New Approach" to harmonized standards.
There are some 30 such directives to date, either adopted or in
preparation, and they set out mandatory technical and safety requirements
for a variety of products, including appliances, electrical machines,
medical devices, passenger lifts, telecommunications products,
recreational boats and children's toys.
Equipment today must be designed for the global market with safety and
EMC compliance in mind. For EMC, both emissions and immunity issues must
be addressed. Typical safety design issues to consider are creepage and
clearance distances, the use of components with third party approval,
printed circuit board layouts, transformer design and construction,
insulation thicknesses, safety interlocks and protective earth grounding.
Many of these items are easily incorporated in new designs but often
become serious issues when one is faced with the redesign of existing
products because of limited enclosure space, EMC compliance issues and the
use of specially designed components.
It is important to recognize the appropriate standards that need to be
met. EN 50081-1, Generic Emission - Residential, commercial and light
industry, EN 50082-1, Generic Immunity - Residential, commercial and light
industry and for safety EN 60335-1, Safety of household and similar
electrical appliances - General requirements, along with the EN 60335-2-xx
series are the applicable standards for appliances.
Manufacturers should evaluate their technical construction files and
declarations of conformity to verify that EMC and Product Safety tests
have been carried out for the complete product.
EUROCONSULT has received information from several manufacturers which
were misguided by suppliers and consultants to believe that no EMC or
product safety testing is required because they are using CE marked
components. Notified bodies from the Netherlands, the United Kingdom and
other European Union countries are saying: "Using sub-systems that
meet testing requirements does not mean that the final product will do
so." It is our experience that many of the CE marked components often
meet only the EMC directive and lack compliance to the Low Voltage
Directive and the appropriate component standards. Components must be
specified properly for their application, must be rated for their specific
use and must comply with the applicable component standards. Components
are defined as items that are used in the composition of the finished
product (ready for use). Components must comply with the relevant EU
standards but usually do not need CE marking since they have no autonomous
use.
A word of caution: many of the CE marked components do not meet product
safety standards. In many cases, a component manufacturer simply declares
compliance based on so called 'in-house testing' carried out in the
manufacturers non-accredited test laboratory.
We have reviewed numerous declarations of conformity of components and
found many non compliant or only partially compliant components. Selecting
components with European and North American third party type approvals
such as VDE, SEV, SEMKO, BSI, UL, CSA is the best protection for any
manufacturer. These type approved components are essential for the
continued compliance with EMC and product safety standards because third
party audits guarantee the consistent quality and safety of these
components and subsequently your product. Using type approved components
also reduces the liability because the company can prove that it acted
responsibly by using approved components.
Using third party approved and/or CE marked components does not permit
the manufacturer of a finished product, which requires CE marking, to
forego any of the EMC and product safety testing. However using these
components is the right step in the direction of designing and
manufacturing the 'Universal Model'. The 'Universal Model' eliminates the
need for having different designs and production for the domestic (120V,
60Hz) and the export (220-240V, 50Hz) markets.
For export to Europe and distribution throughout the EEA the following
is required:
Technical Construction File (TCF) should contain the following: sales
information and brochure, user manual, photo documentation, rating labels
and silk screens, schematics, printed circuit board layouts, listing of
safety critical components including data sheets and licenses, product
safety and EMC test reports. The TCF must be kept current at all times by
keeping all safety relevant changes in components or construction well
documented and included in the file.
Declaration of Conformity (DoC) shall be based on testing and
assessment and must give the assurance that the product conforms to the
applicable directives and standards. The DoC must provide information of
the manufacturer (name and address), equipment description, year of
manufacture, applicable directives and standards.
CE marking is affixed to the finished product that is placed on the EEA
markets as a single unit and intended for the final user.
By not complying with providing the TCF, DoC and CE marking for a
product companies run the risk of having their products rejected by
customs inspectors at the port of entry into the EEA.
With increased internal enforcement within the EEA, finished products
found to be in non-compliance of the regulations, even if, installed and
operating, can subject the manufacturer of the product and the person
signing the DoC to fines and the potential loss of the ability to market
in Europe.
We at EUROCONSULT believe that in a few years, the compliance process
will be routine in the design and development of a product for most
manufacturers, but for now, it is the subject of much discussion, research
and training so that all involved can have an understanding of how and why
it is needed and how to make it a successful process for those companies
participating in the global export market.
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