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GMDN Code Issued

Friday, 8 March 2013 16:39:40 Europe/London

Significant global demand for firesafe devices, together with a large number of medical device registrations has resulted in Firesafe™ devices being recognised with their own unique GMDN code. Firesafe™ cannula Valves and Nozzles have been given the GMDN term 'Fire safety valve' and the code 60391.


The Global Medical Device Nomenclature (GMDN) is a system of internationally agreed descriptors used to identify medical device products. The GMDN Database lists all the terms, which are currently available to name and describe medical devices, although new terms are regularly issued to cope with new medical devices innovations. The GMDN is managed by the GMDN Agency.


For more information about the GMDN Agency visit http://www.gmdnagency.com

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Comments | Posted By BPR Admin

Cannula Burn Back Evaluation

Monday, 21 January 2013 06:02:00 Europe/London

Wendell Hull & Associates, a widely acknowledged leader in the field of oxygen safety testing and forensic engineering, now offer a cannula burn back evaluation service. The new service can provide independent evidence of compliance with the recent amendment to ISO 8359 for oxygen concentrators.


To learn more visit: http://www.wendellhull.com/canula_burnback_evaluation.php


 Cannula Burn Back

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Comments | Posted By BPR Admin

EN ISO 8359/AMD1 - Are you ready?

Friday, 9 November 2012 13:02:08 Europe/London

A presumption of conformity to the Medical Device Directive afforded by compliance with EN ISO 8359 will require evidence that amendment 1 is observed by the 31st January 2013 at the latest. See confirmation of the effective date here http://esearch.cen.eu/esearch/Details.aspx?id=7314685


 Will you be ready? For assistance contact us at cs@bprmedical.com


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Comments | Posted By BPR Admin