EN 60601-1 3rd Edition Electrical Standard Now Harmonized in Europe
European Union regulators have now fully recognized the most recent version of the EN 60601 electrical safety standard, EN 60601-1 3rd Edition, to the European Union’s Medical Devices Directive (MDD). The EN 60601-1 standard was actually released 13 July 2013 under the common designation of Edition 3.1, that has been harmonized under the MDD.
Now that the updated EN 60601 standard has been published in the Official Journal of the European Union, all medical device manufacturers commercialized with European CE Marking must ensure their products conform to the 3rd Edition of the standard by 31 December 2017.
According to Richard Vincins, Vice President of Quality Assurance Consulting at Emergo Group, Annex ZZ of EN 60601-1 3rd Edition makes some notes for the transition period for compliance that may indicate a compliance date much sooner. However, companies should still expect the 31 December 2017 (at the latest) cessation deadline to be enforced.
Vincins notes that differences still exist between major versions of the electrical safety standard—International Electrotechnical Commission (IEC), Underwriters Laboratories (UL) and Europe’s EN designation. In other words, manufacturers in compliance with IEC 60601 3rd Edition may still have work to do in order to meet the requirements of EN 60601-1 or UL 60601-1. Medical device manufacturers should consult with their electrical safety testing laboratories regarding the differences in particular where they plan to sell and distribute their electrical and electronic equipment.
"Having a single electrical safety standard to ease compliance and conformity would be a benefit to the medical device industry," he says. Medical device manufacturers should review current and planned marketing of their electrical medical devices to assure they are meeting the applicable requirements.
Update 18 June 2014
Additional information on this complex topic:
- IEC 60601 3rd Edition (version 3.0) was released in 2005, followed by the release of EN 60601 3rd Edition (3.0) in 2006
- EN 60601 was harmonized in the Official Journal of the European Union in 2008
- IEC 60601 added Amendment 1, also known as version 3.1, in 2012; EN 60601 3rd Edition version 3.1 followed in 2013, and harmonized in the Official Journal in 2014
- EN 60601 3rd Edition version 3.1 contains several hundred changes from version 3.0, some of which are significant
- EN 60601 3rd Edition version has a cessation date of December 2017, but devices for which Annex ZZ of the standard is applicable face a compliance date of 1 January 2016.