Originally Published EMDM
September 2004
Industry News
Updated EMC Standard Takes Effect in NovemberChanges in electromagnetic compatibility (EMC) requirements that will soon come into force are significant enough to jeopardize the CE marking of some electromedical equipment currently on the market. EN 60601-1-2:1993, which details EMC requirements, will be replaced with EN 60601-1-2:2001 on 1 November. The revised standard will apply both to new and existing products, according to Didier Bozec, PhD, senior EMC engineer at York EMC Services Ltd. (York, UK).
The first edition of IEC 601-1-2, which subsequently became the European norm, was published in 1993. At the time, “some of the basic immunity standards were not included,” says Bozec. The new edition incorporates a number of immunity tests that have emerged over the years. In the process, it significantly raises the bar for CE marking.
Among key revisions, Bozec cites enhanced electrostatic-discharge testing and an increase in the frequency range of the radiated immunity test to 2.5 GHz. Also included are tests involving surge, conducted RF, and power-frequency magnetic field immunity; voltage dips and interruptions; harmonic emissions; and flicker disturbances. In addition, “the standard contains more-comprehensive pass/fail criteria,” says Bozec.
“Manufacturers of medical electrical equipment should not underestimate the scale of the changes between the two editions,” cautions York’s operations director Nick Wainwright. “There is no guarantee that products currently in compliance will meet the new requirements.”
York EMC Services Ltd. operates two UKAS-accredited laboratories in the United Kingdom. EMDM readers can find numerous other testing houses located throughout Europe by searching the on-line European Suppliers Directory at www.devicelink.com.
For more information about the capabilities of York EMC Services Ltd., contact the company at the University of York, York YO10 5DD, UK; phone: +44 1904 434440; fax: +44 1904 434434; Internet: www.yorkemc.co.uk.
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