New Editions of Medical Safety Standard Published (posted on 8/13/07)
Significant new editions of the IEC/EN 60601-1 Medical Equipment safety standard were recently published. The long-awaited 3rd edition of this IEC standard was published in December 2005. The European version (EN 60601-1) was published on July 1, 2007 and can be currently implemented. For new appliances covered only by the Part 1 standard, this new European edition is currently scheduled to become mandatory on September 12, 2009.

In addition, each particular Part 2 standard must be updated to align with the new Part 1. For new appliances covered by a particular Part 2 standard, the new edition of the Part 1 standard will become mandatory based on the effective date to be established for each updated Part 2 standard.

Theses new editions of the Part 1 standard have been significantly restructured, the requirements have been further aligned with the IEC/EN 60950-1 standard and a new risk assessment process requirement has been added.

To minimize delays, have your products evaluated now.

EMC
Make sure you're covered! The FCC has specified requirements for testing radiated emissions above 1GHz for several years now. The European Union has no obvious regulations in this respect. However, due to the proliferation of systems using clock frequencies in the several hundreds of MHz, the European Union is now looking at implementing similar requirements in EN 55022 (CISPR 22), and EN 55011 (CISPR 11). They caution manufacturers that even though there are no limits defined above 1GHz, they are still responsible for noninterference at these frequencies. They (the EU) are asking test labs to recommend to their clients testing above 1GHz using the FCC rules as a guide.

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