ISO 18562-2 specifies tests for the emissions of particulate matter 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 ISO 18562-2 are intended to quantify particles from 0,25 µm diameter to 10 µm diameter that are emitted by the medical device, its parts or accessories into the respirable gas stream. It establishes acceptance criteria for these tests.
ISO 18562-2 therefore adopts the same approach as the US Environmental Protection Agency (EPA) in setting limits based solely on particle size and not their chemistry. It addresses potential contamination of the gas stream arising from the gas pathways, which is then conducted on the patient.
This standard applies over the expected lifetime of the medical device in normal use and takes into account the effects of any intended processing. It does not address the biological evaluation of the particles that are deliberately released by a nebulizer (i.e. the therapeutic agent).
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 this document.
ISO 18562-2 does not address contamination already present in the gas supplied from the gas sources while medical devices are in normal use.
ISO 18562-2:2024 text has been approved in Europe as EN ISO 18562-2:2024 without any changes.
