ISO 18562-3 Assessment of Biocompatibility of Respiratory Gas Routes - Part 3: Tests for Emissions of Volatile Organic Compounds (VOCs)

EUROLAB laboratory provides testing and compliance services within the scope of ISO 18562-3 standard. Developed by the International Organization for Standardization (ISO), this part of the ISO 18562 standard specifies tests for emissions of volatile organic compounds (vocs) from the gas lines of parts or accessories of a medical device designed to provide respiratory care or to deliver substances to a patient through the respiratory tract.

The purpose of the tests in this document is to measure the voc emissions added to the respirable gas stream by the materials of the gas path. This document sets out the acceptance criteria for these tests. ISO 18562-3 then addresses possible contamination of the gas flow from the gas pathways delivered to the patient.

ISO 18562-3 applies to the expected service life of the medical device in normal use and takes into account the effects of any intended treatment or reprocessing.

ISO 18562-3 does not address the biological evaluation of the surfaces of gas tracts in direct contact with the patient. Requirements for direct contact surfaces are found in the ISO 10993 series.

Medical devices, parts, or accessories that contain gas paths discussed in this document include, but are not limited to, ventilators, anesthesia workstations (including gas mixers), breathing systems, oxygen protective devices, oxygen concentrators, nebulizers, low pressure hose assemblies. , humidifiers, heat and humidity exchangers, respiratory gas monitors, respiratory monitors, masks, mouthpieces, resuscitators, breathing tubes, respiratory system filters, Y-pieces and any respiratory accessories intended for use with such devices. The closed chamber of an incubator including the mattress and the inner surface of an oxygen hood are considered gas paths and are also covered in this document.

ISO 18562-3 does not address contamination already present in gas supplied from gas sources when medical devices are in normal use. ISO 18562-3:2017 is intended to be read in conjunction with ISO 18562‑1.

Contamination to the medical device from gas sources such as medical gas pipeline systems (including check valves at pipeline outlets), pressure regulator outlets connected to or integrated into a medical gas cylinder, or room air taken into the medical device; It is not addressed by the ISO 18562 series.

This document specifies tests for emissions of volatile organic compounds (vocs) from the gas tracts of parts or accessories of a medical device designed to provide respiratory care or to supply substances to a patient through the respiratory tract in all environments. The purpose of the tests in this document is to measure the voc emissions added to the respirable gas stream by the materials of the gas path. This document sets the acceptance criteria for these tests.

Among the services provided by our organization within the framework of material testing services, there are also ISO 18562-3 standard tests. Do not hesitate to contact our laboratory EUROLAB for your testing and certification requests.