NOVAIR has set up a quality system in accordance to ISO 9001 requirements, certified every year by DNV, an independant organisation of quality evaluation and cerification. A guarantee for our clients of the reliability of our installations and services.
Our main certifications
- ISO 9001:2015 : Quality management system of NOVAIR organisation
- ISO 13485:2016 : 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
Standards observed
- European pharamacopeia (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 distribution systems (including sizing aspects)
- 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.
