Quality : our top priority

Quality : our top priority

NOVAIR has set up a quality system in accordance to ISO 9001 requirements, certified every year by SQS, 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 10083 : international standard regarding the supply of oxygen via oxygen generators for 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.