Medical Oxygen Generators
World-class leader manufacturer
 

Quality : our top priority

NOVAIR Medical has set up a quality system in accordance to ISO 9001 requirements, certified every year by SQS, an independant organisation of quality evaluation and certification. A guarantee for our clients for the reliability of our installations and services. 
 

Our main certifications 


               

ISO 9001:2008 : Quality management system of NOVAIR organisation.
     
ISO 13485:2003 : Quality management system for the design of medical systems. 

CE Medical mark for all NOVAIR medical systems including compressed air and vacuum units and oxygen generators (registration number 1250). 



Standards observed 

European pharamcopeia (PhEur) 
- "Medicinal Air" monography
- "Oxygen 93%" monography 

EN ISO 7396-1: standard related to the design, manufacturing, control and operation of a medical gas system.

FD S 90-155 :
 AFNOR (French Agency for Standardization) document related to the rules of development of medical gases distrtibution systems (including sizing aspects). 

ISO 10083 : international standard regarding the supply of oxygen via oxygen generators for a use in medical gases distribution networks.

ISO 8573-1 : standard defining the pollutants and purity classes of compressed air.           

ANSM (Agence Nationale de Sécurité du Médicament)- recommendations for the use of oxygen concentrators to supply the medical gases distribution network of healthcare facilities. 

Directive 97/23/CEE - DESP : european directive related to under pressure equipment.

U Articles for systems installed in public facilities :
Decree related to the rules of safety against fire and panic in public facilities type U (healthcare facilities). 


In addition...

As an active member of ISO and AFNOR, Novair contributes to drafting all French and European standards related to medical gases production and distribution systems.