Product assessments according to IEC 60601-1:2005 and EN 60601-1:2006 available for applications now

Following the issue of IEC 60601-1:2005, the European Committee for Electrotechnical Standardization (CENELEC) has recently published the new EN 60601-1:2006 standard. This regulation was prepared under a mandate given to CENELEC by the European Commission and the European Free Trade Association, and covers the essential requirements of EC Directives 90/385/EEC and 93/42/EEC.

The new IEC 60601-1:2005 and EN 60601-1:2006 standards have been significantly restructured in comparison to their earlier editions. The most noticeable changes include further alignment of the electrical-safety requirements with those defined for information-technology equipment (covered by IEC/EN 60950-1) and the incorporation of requirements for a risk-management process into overall assessment.

In a continuous effort to offer better, faster and more customized services to our clients, we have expanded its scope of operation to cover product-safety assessment according to the new medical standards. The application of IEC 60601-1:2005 and EN 60601-1:2006 provides manufacturers with a powerful tool for achieving compliance with the latest requirements for product safety and the essential performance of medical devices.

For further details, please contact our Medical Device Service group.