Medical gases
Our specialty since 1977
        
 

Novair Medical vacuum standards & regulations

Novair Medical vacuum application and standards


Vacuum, or medical succion, is a medical gas as defined by standard EN ISO 7396-1.

Medical succion is used for mucus and biological liquids aspiration. It is mainly used in the following services : surgery room, reanimation unit, intensive care unit, emergency unit, pneumology and surgery. 

Considering the use of vacuum in healthcare facilities, medical vacuum units are considered as medical devices.  Their design is strictly regulated at a European level via several standards : 
  • EN ISO 7396-1 standard related to the medical gases distribution systems
  • Directive 93/42/CEE about medical devices, which imposes the CE mark - Medical device class IIa to medical vacuum production units
  • ISO 13485 standard, which details the quality management system requirements for industry and medical devices

 
 
NOVAIR S.A.S -.139, RUE BELLE ETOILE 95700 ROISSY-EN-FRANCE, FRANCE Tél : (+33) 01 56 46 02 03