医疗保健应用中呼吸气体通路的生物相容性评估

This document specifies tests for the emissions of volatile organic substances from the gas pathways of a medical device , its parts or accessories, which are intended to provide respiratory care or supply substances via the respiratory tract to a patient in all environments. The tests of this document are intended to quantify emissions of volatile organic substances that are added to the respirable gas stream by the materials of the gas pathway . This document establishes acceptance criteria for these tests. NOTE Gaseous emission of volatile organic substances includes emissions of volatile organic compounds , semi-volatile organic compound s and very volatile organic compounds . This document addresses potential contamination of the gas stream arising from the gas pathways of medical devices or accessories , which is then conducted to the patient . This document applies over the expected lifetime of the medical device in normal use and takes into account the effects of any intended processing . This document does not address biological evaluation of the surfaces of gas pathways that are in direct contact with the patient . The requirements for direct contact surfaces are found in the ISO 10993 series. Medical devices , parts or accessories containing gas pathways that are addressed by this document include, but are not limited to, ventilators, anaesthesia workstations (including gas mixers), breathing systems, oxygen conserving devices, oxygen concentrators, nebulizers, low-pressure hose assemblies, humidifiers, heat and moisture exchangers, respiratory gas monitors, respiration monitors, masks, medical respiratory personal protective equipment, mouth pieces, resuscitators, breathing tubes, breathing systems filters, Y-pieces and any breathing accessories intended to be used with such devices. The enclosed chamber of an incubator, including the mattress, and the inner surface of an oxygen hood are considered to be gas pathways and are also addressed by this document. This document does not address contamination already present in the gas supplied from the gas sources while medical devices are in normal use . EXAMPLE Contamination arriving at the medical device from gas sources such as medical gas pipeline systems (including the non-return valves in the pipeline outlets), outlets of pressure regulators connected or integral to a medical gas cylinder or room air taken into the medical device is not addressed by ISO 18562 series. This document is intended to be read in conjunction with ISO 18562-1.