Abstract :
From 1 January 1996, all medical devices sold in the EU must bear the CE mark, and must therefore comply with either the EMC Directive, or with the Medical Device Directive (MDD) (active implantable medical devices are covered by their own separate directive). The directives allow three different routes to certify compliance: (1) testing to a set of harmonised standards-the standards route; (2) producing a technical construction file (TCF)-for use where standards are not mature or for a range of similar products; (3) type approval-for radio-communication equipment. As better and cheaper test equipment becomes available, the use of self-test methods will continue to increase, although the investment required for full certification test equipment is only cost effective for the largest companies. The application of EMC measures affects all areas of the company, including marketing, sales, purchasing, manufacturing, quality assurance, installation, and service, but the biggest impact is on the design and test teams. EMC implementation is most cost-effective when designed-in from the early stages of the product development process, and it is important that all design engineers have a thorough understanding of potential EMC problems and techniques for avoiding them. Looking beyond compliance, it is often desirable to develop equipment which achieves better than the minimum standards, particularly for EMC immunity, which will give better performance to the customer, and will help to promote a better quality image for the manufacturer
