This document specifies tests for substances leached by liquid water condensing in
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 chemical characterization methods described in this document apply to chemical substances that could leach from the
medical device, its parts or
accessories into the condensate. This document establishes verifiable acceptance criteria for these tests. The identity and quantity of each chemical released is intended for toxicological
risk assessment as described in ISO 18562-1:2024.
This document addresses potential contamination of the gas stream arising from the
gas pathways, which deliver breathing gas 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 have 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.
This document does not address contact with drugs or anaesthetic agents. If a
medical device or
accessory is intended to be used with anaesthetic agents or drugs, then additional testing can be required. This document is 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.
| File Size : | 1
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| Note : | This product is unavailable in Ukraine, Russia, Belarus |
| Published : | 03/01/2024 |
