International standard IEC 60601-1-9

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 IEC 60601-1 and has been developed drawing on extensive practical experience at Philips Medical Systems and Siemens Medical Solutions.

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. 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 US, 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.

Although the IEC 60601-1-9 standard is focussed on medical electrical equipment, ENVIRON has developed best practice compliance procedures that can assist all medical device manufacturers to gain tangible business benefits from EcoDesign and Product Stewardship.

For further information, please contact Dr Aidan Turnbull
Head of WEEE, RoHS & EcoDesign on +44 (0)1225 748420