Novair Medical vacuum application and standards
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 :
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.
- 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