Travelers know their passport must be in order before they will be allowed trouble-free access to foreign countries. Most wayfarers will not be detained beyond the usual time, but some may be questioned thoroughly if their passport is out of order or if the inspectors suspect something is wrong.
The same is true for manufacturers who want easy access to the unified 15-member European Union (EU). But instead of a passport, they need the CE mark, a type of product passport.
Like the traveler, the product must meet certain requirements before it is allowed into a foreign country. Fortunately, most products with a CE mark will pass without incident. But some may be detained if the paperwork is incorrect or the product raises some concern among the inspectors.
You can avoid these hassles and save yourself time and money as well. The secret of success is to know beforehand what the EU EMC requirements are for your electronic assemblies or where to get the information.
Where to Turn for Help
Test labs offer the help you need to solve a myriad of technical, and even legal, snags both here and abroad. In addition to testing, they furnish seminars, consulting and training to close the knowledge gap and give you unimpeded access to the EU.
Seminars for products entering the EU often address EMC design methods and routes to compliance. Many labs, including CKC Laboratories, provide seminars that cover issues for commercial and industrial products as well as for medical electronics.
Other seminars, such as one presented by DLS, supply a step-by-step explanation of how you can meet the EMC requirements for the CE mark. DLS also presents a half-day briefing on the EU requirements if all you need is an update or if you have specific questions.
Many labs offer consulting to help manufacturers resolve specific EMC issues. A typical consultation at CKC Laboratories includes a free hour-long certification assessment, said Dennis Ward, Director of Labs for the company. “This session introduces companies to the EU requirements that affect the design and marketability of their product. And it is a good primer in EMC design, testing methods and certification routes.”
Some labs offer more encompassing help in the form of training in EMC and EMI control techniques. For example, R & B Enterprises will train you in the testing required by the EU, even showing you how to perform the tests. The content of the courses has been expanded to teach you how to devise a technical construction file for products that have no relevant test standards.
University classes are another option you can pursue for more EMC training. For example, Don Sweeney, President of DLS Electronic Systems, teaches a class on EMC standards and EU requirements at the University of Wisconsin. It covers the fundamentals of EMC using the book Noise Reduction Techniques in Electronic Systems by Henry Ott, and elucidates the details of design using information from the book Controlling Radiated Emissions by Design by Michael Mardiguian.
If you aren’t interested in university classes, you can still keep up with the latest versions of the EU EMC standards. A lineup of standards published in the Official Journal of the EU can help you find the right standard for testing your product (Table 1).
The EU’s Demands
The EU demands that electronic products meet the appropriate standards and that they carry the CE mark. The CE mark 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 mark should be affixed to the product, although some directives allow it to be placed on the packaging or accompanying documentation. If the product is covered by several directives, the mark signifies conformity to all of them.
The EU, however, does not require testing as the only approach to be able to affix the mark. The manufacturer may complete a Declaration of Conformity (DOC) document which states the product meets the requirements of the appropriate standards.
The DOC is a legal document with penalties for making a false declaration, said Dave Imerson, EMC Manager for IBM, United Kingdom. Using an accredited lab indicates that the manufacturer tried to ensure compliance of the product with the standards, he added.
If no standard exists for a product, the EU allows the manufacturer and test lab to use a technical construction file substantiated by an EU-appointed Competent Body. The technical construction file provides the rationale that a product conforms with the intent of the EMC directive.
U.S. manufacturers and test labs have difficulty with the rule that only EU member nations can have a Competent Body. It means that the United States and other nonmember countries cannot perform testing that is accepted by the EU unless a mutually recognized agreement is developed.
The U.S. Government’s Role
The EU wants the federal government to play a role in negotiations regarding mutual recognition of testing. Specifically, the EU would like the Department of Commerce or the FCC to impose test requirements on U.S. test labs.
Some test-lab owners agree that the federal government should play a major role in regulating and certifying labs. “In my opinion, the FCC should not evaluate individual test labs; but it should regulate a few agencies that can adequately evaluate a lab,” said Lee Pulver, President of Pulver Laboratories.
These agencies should be in the accreditation business only, not in the EMC testing profession, suggested Mr. Pulver. Individuals in these agencies should pass formal written and verbal exams administered by the FCC before they can be recognized as experts and allowed to evaluate RF test sites for compliance.
When it comes to product evaluation, the American National Standards Institute (ANSI) has provided a unified approach over the last eight years, said Mr. Pulver. Since ANSI is an accepted standardization agency, the federal government should negotiate with the EU for unconditional acceptance of the ANSI standards.
Some industry observers think the federal government should stay out of the certification business. The government would be providing a service already in place, since many U.S. test labs have already obtained or are in the process of obtaining EU lab certification per EN 45001 or ISO Guide 25 requirements, said Mr. Ward. These are very thorough standards and should be sufficient to meet the quality demands of any regulatory agency, he added.
More test-lab regulations and approvals by the U.S. government would be redundant and unduly burdensome,” continued Mr. Ward. “Customers can be assured of the integrity of a lab with EN 45001, ISO Guide 25 certification and an FCC listing.
However, it is important to note that the EU does not require that U.S. labs meet the provisions of EN 45001, reported Ron Brewer of Instrument Specialties. The EU only demands that labs have an approved quality system in place, such as ISO 9000.
To address these matters, the Department of Commerce has established the National Voluntary Conformity Assessment System Evaluation (NVCASE) organization to develop an EU- recognized laboratory assessment program. It allows the U.S. government to meet the EU demands by recognizing existing conformity assessment bodies such as the NVLAP EMC accreditation program.
Any agreement between the United States and the EU would allow U.S.-based labs to perform the same functions now done solely by the EU Notified Bodies, said Michael Violette, President of Washington Labs. For example, approvals for telecommunications and RF intentional radiators for EU nations must be performed by Notified Bodies. On the other hand, the FCC accepts test data and applications from all countries meeting ANSI C63.4 site requirements.
Parity on the issue of accepting test data from the United States is necessary before any mandatory accreditation of U.S. test labs should be enacted, said Mr. Violette. Otherwise, there is little to gain for U.S. test labs.
The burden of accreditation may evolve into a two-tiered structure for test labs, continued Mr. Violette. One tier would consist of nonaccredited labs that can test to FCC standards, and the other would contain formally accredited labs that can submit test data and applications for approval to the EU.
The EMC directive does allow manufacturers to self-declare a product to any published standard, said Steve Urbanski of Underwriters Laboratories. Because there are many published standards, manufacturers can self-declare, making the need for accredited test labs less critical, he added.
Many U.S. test labs also have made arrangements with EC Competent Bodies to gain acceptance of U.S. test data. But unless industry demands a new U.S. system recognized by the EU and eliminates the need for audits conducted by the Competent Bodies, EN 45001 accreditation will only add expense.
Accompanying this article is a comparison chart of test labs to help you find the company that can meet your needs. It lists the services provided and the capabilities of each lab to test to a variety of standards.
Table 1
Families of Products |
Harmonics |
Emission Voltage Fluctuations |
Radio Interference |
Immunity All Aspects |
Household Appliances and Portable Tools (motor-driven) |
EN 60555-2 1986 |
EN 60555-3 1986 |
EN 55014 1993 |
EN 50082-1 1991 |
TV Receivers and Audio Equipment |
EN 60555-2 1986 |
EN 55013 1993 |
EN 55020 1993 |
|
Information Technology Equipment |
EN 60555-2 1986 |
EN 55022 1986 |
EN 50082-1 1991 |
|
Mains Signaling Equipment |
EN 50081-1 |
EN 50081-1 |
EN 50065-1 1992 |
EN 50082-1 1991 |
Industrial, Scientific, Medical (ISM) Devices |
EN 50081-2 1993 |
EN 50081-2 1993 |
EN 55011 1989 |
prEN 50082-2 |
Industrial Equipment |
EN 50081-2 1993 |
prEN 50082-2 |
||
Low-Voltage Fuses |
EN 60269-1 1993 |
EN 60269-1 1993 |
||
High-Voltage Current-Limiting Fuses |
EN 60282-1 1993 |
EN 60282-1 1993 |
||
Electronic Ripple-Control Meters |
EN 6107 1992 |
EN 61037 1992 |
Copyright 1995 Nelson Publishing Inc.
November 1995