IEC 60601-1-9
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Published in July 2007, the new international standard IEC 60601-1-9 for Environmentally Conscious Design of Medical Electrical Equipment is a collateral standard to the General Standard IEC 60601-1 and has been developed drawing on extensive practical experience at Philips Medical Systems and Siemens Medical Solutions. The Part 9 standard asks manufacturers of medical devices to consider the environmental impacts of their devices throughout the product's entire life cycle and to minimise these where possible. The standard also requires that the manufacturer provide information to the user on how to use the product in the most environmentally sensitive way.
IEC 60601-1 has become the global benchmark for medical electrical equipment and many companies view compliance with IEC 60601-1 as a de facto requirement for most markets for: product registration; “CE” “UL” “CSA” marking; contract tenders; defence against claims in event of problems etc. Clause 1.3 in the latest edition IEC 60601-1:2005 requires compliance with all collateral standards in order to maintain compliance with the main standard IEC 60601-1.
The USA, Canada, Japan, Australia and New Zealand have not yet set transition dates for their national versions of this latest edition 60601-1, but the national versions published to date do contain the requirement to also conform with IEC 60601-1-9. However, the European version (EN 60601-1:2006) requires compliance with the new IEC 60601-1-9 collateral standard by September 2009.
[edit] See also
International Electrotechnical Commission (IEC)
