M/342 - Medical devices

This European Standard is applicable to the performance and safety requirements of fire extinguishing systems and their associated test methods for multi-place chambers designed for pressures in excess of ambient atmospheric pressure and employed in medical installations for therapeutic purposes, in the following referred to as chambers.

This European Standard is applicable to the performance and safety requirements of fire extinguishing systems and their associated test methods for multi-place chambers designed for pressures in excess of ambient atmospheric pressure and employed in medical installations for therapeutic purposes, in the following referred to as chambers.

This European Standard is applicable to the performance and safety requirements and their associated test methods for multi-place pressure chambers designed for pressures in excess of ambient atmospheric pressure and employed in medical installations for therapeutic purposes, in the following referred to as pressure chambers. Pressure chambers for therapeutic use are required for the administration of hyperbaric oxygen therapy and for the treatment of decompression illness. These chambers are made to allow the safe administration of hyperoxic gas mixtures at pressure while avoiding the risks of fire within the chamber and of uncontrolled compression or decompression. They need to allow all levels of patient care up to intensive care with all the necessary equipment and provide a safe working environment for patient carers. Standards on ergonomics for the design of pressure chambers for therapeutic use are not available. Nevertheless guidance for the application of ergonomics standards is given in the bibliography. Chambers providing exclusively for hyperbaric oxygen therapy operate typically with a maximum operational pressure of 200 kPa (2 bar) above atmospheric pressure. Pressure chambers providing treatment for decompression illness have a maximum operating pressure of 500 kPa (5 bar) or more. Treatment times in the chamber are typically 2 h to 3 h for hyperbaric oxygen treatments while standard treatment for decompression illness may last 8,5 h or more. Atmospheric conditions within the chamber need to be comfortable and, in particular, oxygen levels require control in order to avoid hypoxia, oxygen toxicity and undue risk of fire.

This European Standard is applicable to the performance and safety requirements and their associated test methods for multi-place pressure chambers designed for pressures in excess of ambient atmospheric pressure and employed in medical installations for therapeutic purposes, in the following referred to as pressure chambers.

The standard covers general requirements for fire extinguishing systems which are an essential component of hyperbaric chambers. The document covers specific requirements for fire extinguishing systems including the design, performance, installation and testing and shall be regarded as a complement to the existing document EN 14931.

This European Standard is applicable to the performance and safety requirements of fire extinguishing
systems and their associated test methods for multi-place chambers designed for pressures in excess of
ambient atmospheric pressure and employed in medical installations for therapeutic purposes, in the following
referred to as chambers.