Biocompatibility evaluation of breathing gas pathways in healthcare applications -- Part 4: Tests for leachables in condensate
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ISO 18562-4:2017 specifies tests for substances leached by liquid water condensing into 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 hazardous water-soluble substances that are leached from the medical device, its parts or accessories by condensate and then conveyed by that liquid to the patient. This document establishes acceptance criteria for these tests.
ISO 18562-4:2017 addresses potential contamination of the gas stream arising from the gas pathways, which is then conducted to the patient.
ISO 18562-4:2017 applies over the expected service life of the medical device in normal use and takes into account the effects of any intended processing or reprocessing
ISO 18562-4:2017 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, 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.
ISO 18562-4:2017 does not address contamination already present in the gas supplied from the gas sources while medical devices are in normal use.
EXAMPLE Contamination arriving ...