ISO 18562-3 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 ISO 18562-3 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 standard establishes acceptance criteria for these tests.
ISO 18562-3 addresses potential contamination of the gas stream arising from the gas pathways of medical devices or accessories, which is then conducted to the patient. It applies over the expected lifetime of the medical device in normal use and takes into account the effects of any intended processing.
Medical devices, parts or accessories containing gas pathways that are addressed by ISO 18562-3 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 is intended to be read in conjunction with ISO 18562-1. ISO 18562-3:2024 text has been approved in Europe as EN ISO 18562-3:2024 without any changes.
