The 15-member European Union (EU) demands that electronic products meet appropriate standards and that they carry the CE marking. The CE marking indicates that the product complies with the basic EMC requirements and that the manufacturer or a third party has carried out the relevant assessment.
The EMC Directive covers everything electrical. To quote a member of the U.K.
Department of Trade and Industry, “If it has an electron in it and the electron moves, it must comply.” That’s a bit of an exaggeration but, nevertheless, it is an all-embracing directive.
Unless your product is specifically excluded, it is included. The directive simply says that, to comply, your product must have an adequate level of immunity and not interfere with other systems and products.
Many test labs offer consulting services to help you resolve specific EMC issues, including engineering design, preliminary test methods and compliance. A quality test lab also keeps up with advances being made in new technology.
Testing facilities must be diligent about equipment maintenance and customer service. Remember, the testing is only as good as the equipment and the up-to-date education of the people performing the tests. Since the cost of testing is fairly competitive, base your selection of a test lab on the quality of customer service offered.
Failing to Comply
Failure to comply with any one of the directives could result in:
A fine.
A prison sentence.
Shipments turned away from port.
Products removed from markets throughout Europe.
Loss of company reputation and image.
No more sales in the EU.
To avoid these expensive risks, a Competent Body or a Notified Body and an accredited test lab can help you attain the required EMC compliance certification and CE marking for your products. If you use a Competent Body or a Notified Body, get them involved early in product design and development. Do not wait until everything is complete.
The bodies and their test labs are appointed on the basis of their experience and can give you very valuable advice. Together they may be able to prevent you from making costly mistakes.
Routes to Compliance
Essentially, there are two routes to compliance: Your product must meet either the appropriate European norms or a specification “invented” by you in conjunction with a Competent Body or a Notified Body. The Competent Body/Notified Body specifications are presented along with information that demonstrates you meet the essential requirements in a Technical Construction File (TCF). Approval of the file is made by a Competent Body or a Notified Body.
Competent Body or Notified Body
Each member state of the European Community appoints Competent Bodies and Notified Bodies. Your first criterion is to select a Competent Body or a Notified Body
in a member country of the European Community.
Next, develop a professional relationship with open lines of communication. The body will advise you in all aspects of the applicable directives and will assist you in preparing the necessary documentation.
Competent Body
Competent Bodies are appointed because they know what they are doing in the world of EMC. In the EU, the appointment of Competent Bodies is based on its ability to make value judgments on the performance of a product. This will not be based solely on the test; the body also must analyze the construction of the equipment. A Competent Body reviews the TCF and generates Certificates of Conformity.
Notified Body
The duties of the Notified Body include:
Type Examination—may include testing of a representative sample of a product against a range of standards, and assessing the documentation that defines the product.
Verification Testing—either testing every item produced or using statistical sampling to verify conformity.
QA System Audit—auditing of some or all of the manufacturer’s capabilities and processes with periodic surveillance. Audit teams must include at least one member experienced in the evaluation of the technologies used in the manufacture of the product but does not have to be an employee of the Notified Body.
Design Examination—assessment of the product-design dossier.
Any of the activities may be subcontracted by the Notified Body to a specialist, but the quality system must ensure that the activities are carried out as if they had been done by the Notified Body itself. The overall responsibility to review the assessment and verification activities and make judgments in relation to the conformity of a device may not be subcontracted.
Self-Declaration
If you wish to use the European-norm route, then you must choose a specification appropriate to the product and show compliance for self-declaration. If there are none, then you may use the European generic specifications for the environment in which the products are to be used.
In the absence of European norms, applicable national specifications of the EC states may be used to show compliance. Once you have identified the appropriate specifications that apply to your product, all you have to do is show that it complies. This can be done either by testing or theoretical analysis.
How Can a Competent Body Help?
A Competent Body will guide you into obtaining compliance by helping you meet a specification that you developed. This route is typically used for five main reasons:
Where there is no applicable harmonized standard.
When a harmonized standard is applied in part only.
Where testing to harmonized standards is not possible due to the physical properties of the installation.
Where the testing of each product is not practical due to large numbers of similar product variants.
Where the product was previously certified to EMC standards not recognized by the EC.
This route applies to many products, particularly in the area of industrial control systems, and products that have already been shown to comply with specifications such as FCC 15 and FCC 18.
With the TCF route, unlike the self-certification route, you cannot perform your own certification. If you choose the TCF route, you must engage the services of a Competent Body to comply with the European requirements.
A Word of Warning
Remember, no one is perfect; it’s how a company reacts and handles your problems that matters. When you hire a test lab, a Competent Body or a Notified Body, it becomes an essential adjunct of your company and is contracted to support your program and goals—a contract that can only be in the best interest of everyone to develop a strong, long-lasting relationship.
Testing is the last step in the manufacturing process and should not be the most difficult. Let your Competent Body or Notified Body help you avoid costly mistakes.
Compliance is a critical path to market in the European Community. Choose carefully and wisely.
About the Authors
Henry Snyder has been the Vice President of Marketing and Sales at Radiation Sciences since 1983. Mr. Snyder has a degree in marketing from MCCC, PA. Radiation Sciences, 3131 Detwiler Rd., Harleysville, PA 19438, (215) 256-4133.
Butch M. Sarma is Manager, Corporate Development at Technology International, a U.K. Competent Body for the EMC Directive. Mr. Sarma has B.A. and M.B.A. degrees from Old Dominion University. Technology International, 705 Twin Ridge Ln., Richmond, VA 23235, (804) 560-5334.
Competent Body—for all electronic products other than medical, under the EMC Directive; lists available from EC Commission in Brussels.
Notified Body—for all medical-related and communications transmission equipment, under the Medical Devices Directive; lists available from the Medical Devices Agency.
Copyright 1996 Nelson Publishing Inc.
October 1996