Medical gases
Our specialty since 1977
        
 

Novair Medical Quality & Regulations

Novair Medical air applications


There are four main applications to medical air : 

  • Breathing: medical air (or medicinal air)is commonly used by respirators for anesthesia and intensive care
  • Aerosol: It is also used for nebulization.
  • Surgery: The air produced by NOVAIR stations can also be used as motor ai. Same quality as the medical air, it is used at a different pressure thereof, as driving force for surgical instruments, or to dry them after disinfection. 
  • Suction : medical air can be used as motor gas connected to aspiration outlets for anaesthesy gases

Quality standards


Considering the applications listed above, medical air has the status of "medicament". Therefore, it must be produced under  specific condition and european frame defined by :

  • EN ISO 7396-1 standard related to medical gases  distribution systems
  • The European Pharmacopoeia
  • Directive 93/42/EEC on medical devices, which imposes the CE - Medical device mark Class IIa for all medical air production units
  • ISO 13485 standard related to quality management systmes for medical devices industry

European pharmacopeia

Parameters   European pharmacopeia Medical air Novair
medical air stations
Oxygen O2 20,4% à 21,4% 20,4% à 21,4%
Carbon Monoxide CO < 5 ppm < 2 ppm (0.0002%)
Carbon Dioxide CO2 < 500 ppm < 300 ppm (0.015%)
Sulfur Dioxide SO2 < 1 ppm 0 ppm
Nitrogen Oxides NOx < 2 ppm 0 ppm
Water  H2O  < 67 ppm
(-50°C)
 < 3 ppm
(-75°C / -107°F)
 Oil  -  < 0.1 mg/m3  < 0.063 mg/m3
 
 
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