ISO 18562-4 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. ISO 18562-4 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 standard addresses potential contamination of the gas stream arising from the gas pathways, which deliver breathing gas to the patient. ISO 18562-4 applies over the expected lifetime of the medical device in normal use and considers the effects of any intended processing.
Medical devices, parts or accessories containing gas pathways that are addressed by this document include, but are not limited to, ventilators, anesthesia 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, mouthpieces, 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 ISO 18562-4.
It does not address contact with drugs or anesthetic agents. If a medical device or accessory is intended to be used with anesthetic agents or drugs, then additional testing can be required. This standard 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.
ISO 18562-4:2024 text has been approved in Europe as EN ISO 18562-4:2024 without any changes.
