Regulatory Framework Products Covered Routes to Compliance
Markings and Documentation Maintaining Conformity
Regulatory Framework
The European Union (EU) consists of the following 15 European countries: Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, The Netherlands,
Portugal, Spain, Sweden, United Kingdom For the majority of electrical and electronic products, EMC requirements in the European Union are covered by the EMC Directive (full text), 89/336/EEC, amended by 92/31/EEC, 93/97/EEC and 93/68/EEC.
Certain product types have EMC requirements which are covered by other EU Directives. These are: Motor vehicles - covered by the Automotive EMC Directive, 95/54/EEC
Active implantable medical devices - covered by the Active Implantable Medical Device Directive, 90/385/EEC.Medical devices - covered by the Medical Devices Directive, 93/42/EEC
.In vitro diagnostic medical devices - covered by the
In-vitro Diagnostic Medical Devices Directive, 98/79/EEC.Marine equipment, covered by the Marine Equipment Directive, 96/98/EEC
.Equipment for use in aircraft in flight, covered by Council Regulation No 3922/91. This page does not cover the requirements of these
directives. Generally technical requirements are similar to those of the EMC Directive, though regulatory requirments will differ. An EU Directive is not in itself a law, but is a Directive to
the governments of EU members to prepare laws implementing the Directive. The EU publishes "
Guidelines on the Directive, issued by the Commission", a very useful guide to
the requirements of the EMC Directive
Products Covered The EMC Directive covers electrical appliances, systems and installations. The Directive covers both emissions and immunity. However, products covered by other directives noted above have EMC requirements
which are covered by the provisions in those specific directives. The subject of the scope of the EMC Directive with relation to:
- components
- finished products
- systems
- installations
is quite complex. This subject is covered in depth in section 6 of the " Guidelines on the Directive, issued by the Commission". Exemptions:
Products considered electromagnetically passive are excluded from the scope of the directive. Examples are:
- cable and cabling systems
- equipment containing only resistive loads without any automatic switching device
- batteries and accumulators
Certain other equipment is also considered exempt, for example:
- fuses
- circuit breakers without electronic parts, or other parts which are electromagnetically active
- manual switches, without parts which are electromagnetically active
- filament lamps
- quartz wrist watches, without additional functions
In addition, radio equipment used by radio amateurs is specifically excluded, unless the equipment is commercially available.
Routes to Compliance This information describes the routes to compliance to the EMC Directive. It does not cover compliance of EMC
requirements required for products covered by other directives (see above). The EMC Directive allows three routes to compliance: The Standards Route. Products are assumed to comply with the requirements of the EMC Directive, if they can
be shown to comply with the appropriate Harmonized
Standard, as published in the Official Journal of the European Union. If there is a product specific harmonized standard, then this standard must be used,
otherwise the appropriate generic harmonized standard can be used. Generic standards are:
- EN 50081-1 Emissions - Residential, commercial and light industry
- EN 50081-2 Emissions - Industrial environment
- EN 50082-1 Immunity - Residential, commercial and light industry
- EN 50082-2 Immunity - Industrial environment
The manufacturer must build a technical file showing how the product complies with the appropriate Harmonized Standard. Most frequently, this will include a test report
from a third party test house. Nevertheless, compliance may be justified on the basis of the manufacturer's own measurements, or even based purely on engineering
arguments, without any test results. It is clear, though that the manufacturer's own data or engineering arguments would come under much greater scrutiny than a third party test report, in the case where the European
authorities have reason to examine a manufacturer's claim to compliance. The Technical Construction File (TCF) Route. The manufacturer may choose to build a Technical Construction File and present it to a Competent Body
for assessment. If the competent body agrees that the TCF proves compliance with the Directive, it will issue a
certificate certifying this. Reasons for using the TCF route include:
- There are no Harmonized Standards for the product
- Full Testing to the Harmonized Standard in impractical due to the size or location of the product
- A product range of many similar products, where testing each version would not be economical
Radio Transmission Equipment has its own route to
compliance, involving submission of the equipment to a
Notified Body, and the issuance of an EC type examination certificate. However this route is now no
longer relevant for almost all such equipment, given the advent of the R&TTE Directive, 1999/5/EEC.
Markings and Documentation.  By CE Marking the product
and/or the packaging, the manufacturer declares that the product complies with all applicable EU Directives. For some products, the EMC Directive may be the only applicable directive, but for
the majority of electrical and electronic products, other directives, usually related to safety, will be applicable, e.g. the Low Voltage Directive, the Machinery Directive, the RTTE (Telecoms) Directive, etc.
In addition to the CE Marking, the manufacturer must prepare and sign a Declaration of Conformity. An example DoC is shown below. A copy of the DoC must
be included with each item of the product shipped. Many manufacturers include the DoC in the User Manual. It is also recommended to include a copy of the DoC in shipping documents.
EC Declaration of ConformityCouncil Directive 89/336/EEC on Electromagnetic Compatibility We (Name and address of manufacturer)
Certify that the product described is in conformity with the Directive 89/336/EEC as amended.
(Name, type or model, lot, batch or serial no. etc.)
(Description)
(Standards Route) The product has been assessed by the application of the following standards
(Standard Number) (Date of Issue)
(Standard Number) (Date of Issue)
(TCF Route) The product is consistent with a technical construction file showing conformity with the essential requirements of the directive
Name of Competent Body) ( Certificate No.) (Date of Issue)
(Radio Transmission Equipment Route) The product is consistent with the EC type examination certificate
(Number and Date of Certificate) (Name and number of Notified Body)
(Name of Responsible Person) (Signature of Responsible Person) (Date) |
|
Notes:
- Words in italics and in brackets are for explanation only, and are not part of the declaration
- Only one of the options:
(Standards Route), (TCF Route), (Radio Transmission Equipment Route) is appropriate in any particular case. Delete the two options which are not applicable.
This example declaration refers only to the EMC Directive. Reference to other applicable directives may be added to this declaration, or may be included with the product as a separate declaration.
Maintaining ConformityThe manufacturer should take steps to ensure that his production remains compliant with the Directive. These steps may include:
- Basic quality procedures that ensure consistent production of the product
- Review of the effect on compliance of changes in design or of the applicable standards
- Periodic retesting (at least on a comparison basis)
- These measures must be documented, so that the the manufacturer can prove to the authorities, if requested, that steps are taken to ensure continued compliance.
|
