With the release of a new medical standard (as with any) there comes a certain amount of apprehension and concern about how current and future products will fit into a new testing scheme. In the medical field this is especially true, as there are additional factors that come into play when seeking approval, as compared to typical consumer products. The fourth edition of IEC 60601-1-2 brings with it a revamped product classification system for both emissions and immunity.
Gone is the old system based on whether or not a product is life supporting, replaced by a classification system based on intended use environment. The new organizational model is better suited for the diverse range of products found in today’s medical field. In order to reduce the susceptibility of these products the fourth edition has increased, added to or changed many of the stress levels for the immunity tests. One of the major focuses addresses the increased proliferation of wireless devices across multiple frequency bands. With these changes in the immunity suite, this will result in a rather distinct difference in tests when compared to the third edition. This is an important point to remember when considering upcoming compliance testing.
At this post, the fourth edition is still several years away from being requisite, and not published in the Official Journal associated with the Medical Directive. For further information regarding these changes or questions regarding the approvals process, you may contact LSR through our website at www.lsr.com, connect with us on LinkedIn, or find our latest news and information on Twitter by following @lsresearch.