Tag: medical devices directive
The European Commission has been busy updating lists of European harmonized standards for various product directives. Here are the updates to the Official Journal (OJ) of the European Union, looking back from the most recent:
May 4, 2012 – Updates to the ATEX Directive (94/9/EC), the European CE directive that applies to equipment used in potentially explosive atmospheres.
The list introduces two new European harmonized standards:
- EN 13617-2:2012 Petrol filling stations – Part 2: Safety requirements for construction and performance of safe breaks for use on metering pumps and dispensers. Replaces the 2004 version with the same number and must be applied by September 30, 2012.
- EN 60079-11:2012 Explosive atmospheres – Part 11: Equipment protection by intrinsic safety ‘i’ (IEC 60079-11:2011). Replaces EN 60079-11:2007 + EN 60079-27:2008 + EN 61241-11:2006 and must be applied by August 4, 2014.
For explanation of the new EN 60079 standard and other updates, register for this July 17 seminar: Hazardous Location Product Safety Compliance for North America (UL & CSA), EU (ATEX) & World (IECEx)
April 11, 2012 – Updates to the Radio and Telecommunication Terminal (R&TTE) Directive (1999/5/EC) and the EMC Directive (2004/108/EC).
February 29, 2012 – Updates to the Machinery Directive (2006/42/EC).
These updated lists are important for manufacturers of relevant CE-marked products that have used European harmonized standards to prove CE compliance. If you have applied standards to prove compliance with the aforementioned directives, you’ll need to reevaluate your products against the updated or new standards and update your Declaration of Conformity.
Request pricing and lead time for CE Mark testing.