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What is the CE Mark?

The CE Mark indicates that your product has been tested for compliance with the safety requirements of the European Community. Why test?

  • It is the concern of the United States and European Community that its citizens remain safe in the conduct of normal commerce and it is the law that manufacturers protect their equipment adequately so that injuries or unintended operation do not occur.
  • Obtaining the mark is an important step in marketing your products globally.
  • Penalties are very high for noncompliance. Manufacturers can be prevented from distributing their products in EC member countries.
  • Testing may provide protection in court against frivolous lawsuits.
  • For electrical equipment, emission and susceptibility testing has been found effective in eliminating unwanted failure modes.
  • When equipment passes the required tests, there usually is no need for the manufacturer to take any extra precautions to provide product safety.

How Does a CE Mark Certification Work?

The following is a brief synopsis of the process Midwest EMI Associates uses to help manufacturers obtain CE Mark certification for their products.

Determine product to be tested

Midwest EMI and NEMKO assist you in determining the product models to market in United States and Europe. We ask that you provide the following information so Midwest EMI can begin the type acceptance process:

  • Is the device a medical or commercial product?
  • What are the input power requirements of the device? If power can be either 120 or 240 VAC, the product should be configured to 240 VAC for testing.
  • Is safety testing needed? If so, we have experienced personnel and the test equipment necessary to perform safety tests.
  • What EMI test specification must be met? Different requirements apply to different markets. Midwest EMI can assist you in determining the test requirements for your product.
  • What are the operating test limits or accuracy and performance pass/fail criteria for the product?
  • If the device to be tested is a prototype, can it be considered representative of the production device?
  • For testing purposes, how should the product be operated?
  • Does the product have peripheral lines? If so, all peripheral lines should have representative cables connected to them.
  • Is the proper EMI shielding scheme present on the product?
  • Is the product assembled properly?

Conduct Tests

Deliver test device

Midwest EMI usually responds within one day to your request for a quotation. If the quotation is acceptable, we ask that you issue a purchase order. We welcome customers to tour our lab prior to delivering the test device to our laboratory. Customers are welcome to observe the testing. Midwest EMI normally requires 1 to 2 weeks to conduct tests. Short-term tests can be performed overnight if necessary.

Testing stage to CE Mark (emissions testing)

The least invasive tests are typically performed first. Conducted emissions and radiated emissions tests can usually reveal latent problems that require EMI fixes before more invasive tests are performed.

Testing Stage to CE Mark (Emissions EMI Additions)

This is the critical step to obtaining the CE Mark. The conducted emissions test may require additions to the power line configuration such as EMI filters, capacitors and inductors. The radiated emissions test usually requires ferrite absorbers, inductors or capacitors at specific places determined through our testing. We advise the customer of shortcomings and help research alternatives– many options are available at Midwest EMI including a full inventory of EMI components. Midwest EMI has NARTE certified personnel who can solve the most difficult EMI problems. It is usually more economical to address emissions problems immediately rather than wait for all testing to be completed.

Testing Stage to CE Mark (Susceptibility Testing)

This step usually consists of several alternative tests, typically radiated susceptibility, conducted immunity, electrostatic discharge, electrical fast transients, electrical surge test and voltage fluctuations tests. For medical products, testing may also include some MIL-STD-461 tests, special tests from the FDA Reviewer’s Guide, or proprietary Midwest EMI tests. Midwest EMI can perform all of these tests and more, including specialized magnetic susceptibility tests. We usually recommend that ESD testing be performed last because it can render equipment inactive, preventing further testing. We strongly recommend that you have backup units or components on hand.

Roadblocks to Susceptibility Testing

The following are common problems to keep in mind when preparing products for susceptibility testing:

  • Failure to configure the products intended for European submission for 240 VAC input power
  • Failure to have an acceptance criterion established prior to the test before submission.
  • Failure to have appropriate software that will indicate the proper state of the unit as being “Normal” or “Failed”
  • Failure to have established limits on the accuracy to be maintained during the test
  • Failure to supply cables which simulate connections to the device under test

Prepare Test Report

Midwest EMI normally writes a test report after discussing the test results with you. Our full color reports include graphic test results and photos of the test setups used. All testing is automated and all equipment is certified to demanding NIST requirements. (NIST certification expiration dates are listed in the report.) The reports are easy to read, indicate actions taken, and include recommendations for achieving compliance. Midwest EMI maintains an archive of each test report. We can regenerate your report from our copy if necessary.

Redesign/Retest

If the testing indicated that areas of the product design require change in order to comply with test requirements, we can work with you to recommend changes and help you implement them. After design changes have been made, Midwest EMI retests the product to verify compliance and documents the test results.

Conduct Safety Testing

NEMKO safety testing can be conducted before or after EMI testing. In our experience it is best to do EMI testing first because EMI testing may point out areas where design changes may be necessary. In particular, problems in the conducted emissions portion of the test may change filters or components important to safety testing.

Conclusion

NEMKO is a Norwegian "Notified Body", that reviews and recognizes Midwest EMI’s test and safety reports. Midwest EMI, CE Compliance, and NEMKO are unique entities that work together. NEMKO typically may request “witness testing” during sponsor group testing. This is especially true for companies without an established track record. It is not guaranteed that results taken with other notified bodies will be acceptable to NEMKO unless certification has been given (it may be necessary to test the product over again in certain areas). Midwest EMI maintains office space to allow customers to meet with and answer questions from NEMKO representatives.

You can count on professional help from Midwest EMI Associates before, during and after the testing is over. The importing agency can perform testing at any time and can request test results. To learn more about CE Mark certification testing and our NEMKO recognition, call us or stop by and tour our test laboratory.

Visit our Contact Us page to find out more information, a quote, or to leave comment for us.