On 24th January 2015, EN ISO 8359:2009/A1:2012 was added to the list of harmonised standards published in the official Journal of the European Union.
This standard is used to provide a presumption of conformity with many of the essential requirements of Council Directive 93/42/EEC concerning medical devices. EN ISO 8359:2009/A1:2012 includes several normative requirements intended to mitigate the risk of fire with the use of oxygen concentrators.
EN ISO 8359:2009 became obsolete in the Official Journal of the European Union (OJEU) on 31st January 2013 and national adoption of the amendment by the 28 EU member states now complete. Providers of home oxygen services should be aware of their responsibility to provide suitable accessories that mitigate the risk of fire.
Firesafe Cannula Valves satisfy the requirements of the new standard perfectly. If you need any advice or further information please contact us and we'll be happy to provide concise guidance and assistance.