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The CE-markThe ce-mark is the official European symbol on your equipment, showing that it fulfills essential requirements in the field of safety to operator, environment and other equipment. It will however open the entire European market at once for your products, with only language differences for you to bridge. The ce-mark is required for all equipment to be sold or put in service on the European continent, for non-European AND European manufacturers. Read more about the ce-mark. DirectivesThe application of the ce-mark is ruled by so-called New Approach Directives. These pan-European directives do not govern by detailing specific requirements, but by so-called Essential Requirements. Specifying details is left over to the market, and is been done by CENELEC (and others), standards based on published by the IEC. Directives exist for most categories of equipment exhibiting a potential danger to the public, environment or other equipment. For electrical and electronic equipment, directives have been published concerning :
Electrical Safety Directive [73/23/EEC]Electrical safety has been regulated all over the world, and companies world wide have got used to testing their equipment in dedicated laboratories to become f.a. the CSA-, GS- or UL or VDE-mark. These company related marks have expanded their reach somewhat beyond their strictly commercial use, and some became a barrier in exporting to the different European Countries as each country required a local marking. Since 1-Jan-1997 only one mark is allowed, the ce-mark. Testing and declaring has become an obligation that can be fulfilled by the company itself. No special laboratory or homologation is required, and whats even more important, one mark suffices for all Europe. The equipment has however to be tested according to the safety standards published by the CENELEC and notified by the European Commission.
EMC-directive [89/336/EEC]Electro Magnetic Compatibility is an expression for the way electric and electronic equipment behave in their electro magnetic environment, i.e. how much they pollute it's EM environment generating E- and/or H-field. The European Community brought EMC of electrical and electronic equipment and apparatus under the ce-marking regime, publishing a dedicated pan-European directive (89/336/EEG). An important difference with the past is the inclusion of paragraphs and tests for determining the susceptibility of electronic and electrical equipment to a wide spectrum of interference phenomena. Among these are EM-fields, Electrical Static Discharges, Fast transients and Surge Impulses. The list is steadily expanding both in depth as in horizon. Up to 28 different immunity tests are bound to be harmonized in the upcoming years. Popular standards are
Radio & Terminal Equipment Directive [99/5/EEC]Terminal equipment characterizes itself by being on the end of a public telecommunications network Standardization is done by ETSI. We can perform type examinations on most analogue and radio equipment. We have a specialization in Short Range Devices. (SRD). The terminal directive makes a direct link to the requirements of both EMC- and Low Voltage directive as part of the compliance assessment; the latter without the supply voltage limitations. Notified body involvement only for radio frequencies per country. In force per April 8th, 2000
Medical Devices Directive (MDD) [92/42/EC]Medical appliances and devices are covered by this directive. Electronic equipment, having a measurement function, being invasive or getting in contact with human tissue (patients, sterile), must be type tested by a competent body. An important issue here is safety of the patient, and therefore certification is also required for applied software in these electronic instruments. This type of equipment should be monitored after sales for incidents registration and vigilance. Functional requirements are part of the type tests. An exception to this type testing is for Class 1 not-invasive equipment without a measurement function. For these equipment the Manufacturers declaration is to be used.
We may assist you in creating a TCF (Technical Construction File) for the MDD for electric and electronic equipment. We shortly ago started a service in approving software in embedded systems for MDD and Electrical Safety purposes. Relevant standards are :
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