Countdown to June 2012: IEC 60601-1 Third Edition
22 August 2011
The adoption of the 3rd Edition of IEC 60601-1 has been slow since its release in December 2005. Each country’s testing agencies and regulatory bodies are transitioning to the 3rd Edition at a different pace, making it difficult to develop a consolidated test plan.
However, the time is critical to most medical device manufacturers:
- Europe: 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.
- Canada: By June 2012, all new Canadian medical product, submitted to Health Canada, need to meet the requirements of CAN/CSA-C22.2 No. 60601-1: 2008.
- North America: By July 2013, all new medical products in the US, submitted to FDA, need to meet the requirements of ANSI/AAMI ES60601-1: 2005.
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?