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IIEC 60601-1:2006 Third Edition Countdown to June 2012 |
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IEC 60601-1:2006, Medical electrical equipment Part 1 General requirement for safety. The third Edition of IEC 60601-1 has been released in December 2005. and which under transitioning status by each country¡¯s testing agencies and regulatory bodies, however, at a different pace, still not reach the same result, the time is critical to most medical device manufacturers: Such as for Europe, according to policy, by June 2012, all European medical products (existing and new) need to comply with CENELEC EN 60601-1: 2006, unless not all particular standards have been harmonized with CENELEC EN 60601-1: 2006. But what does your company need to do if it still not registered? What steps need to be taken now to ensure that your device meets the standards under Third Edition? |
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