ISO 5359:2014 pdf free
ISO 5359:2014 pdf free.Anaesthetic and respiratory equipment – Low-pressure hose assemblies for use with medical gases
Where appropriate, clinical investigations shall be performed under the conditions for which performance is claimed and documented in the risk management file. The clinical investigations shall comply with the requirements of ISO 14155.
Check compliance by inspection of the risk management file.
NOTE A clinical investigation can be either
a) a critical evaluation of the relevant scientific literature currently available relating to the safety, performance, design characteristics and intended purpose of the device, where there is demonstration of equivalence of the device to the device to which the data relates, and the data adequately demonstrates compliance with the relevant essential requirements, or
b) a critical evaluation of the results of all clinical investigations made, or
c) a critical evaluation of the combined clinical data provided in a) and b).
Hose assemblies shall, when transported, stored, installed, operated in normal use and maintained according to the instructions of the manufacturer, cause no safety hazard which could be foreseen using risk analysis procedures in accordance with ISO 14971 and which is related to their intended application, in normal condition and in single-fault condition.
NOTE It has been reported that when using “quick connectors” there is a potential hazard when disconnecting from the terminal unit. There can be a release of pressure that can cause a sudden unpredictable movement of the hose resulting in injury to the operator and other personnel or damage to the equipment.
The materials in contact with the medical gas shall be compatible with oxygen, the other medical gases and their mixtures in the temperature range specified in 4.5.4 under normal and single faultconditions.
NOTE 1 Corrosion resistance includes resistance to moisture and surrounding materials.
NOTE 2 Compatibility with oxygen involves both combustibility and ease of ignition. Materials which burn in air will burn violently in pure oxygen. Many materials which do not burn in air will do so in pure oxygen, particularly under pressure. Similarly, materials which can be ignited in air require lower ignition energies for ignition in oxygen. Many such materials can be ignited by adiabatic compression produced when oxygen is rapidly introduced into a system initially at low pressure.
NOTE 3 ISO 15001 contains information on selection of metallic and non-metallic materials and other aspects of compatibility with the equipment.
Check compliance by inspection of the technical file.ISO 5359 pdf download.
