ISO 18562-2 Biocompatibility Assessment of Respiratory Gas Routes in Healthcare Applications - Part 2: Tests for Particulate Matter Emissions

EUROLAB laboratory provides testing and compliance services within the scope of ISO 18562-2 standard. Developed by the International Organization for Standardization (ISO), this part of the ISO 18562 standard specifies tests for particulate matter emissions from the gas pathways of a medical device, its parts or accessories intended to supply substances to a patient through respiratory care or the respiratory tract in all settings.

The tests of this document aim to determine the amount of particles from 0,2 µm in diameter to 10 µm in diameter emitted into the respirable gas stream by the medical device, its parts or accessories.

This document sets the acceptance criteria for these tests. This document does not deal with nanoparticles. There are insufficient data to determine exposure limits for particles smaller than 0,2 µm in diameter.

Smaller and larger particles may also present biohazards and additional information beyond the scope of this document may be needed to meet the requirements of some jurisdictions. Therefore, ISO 18562-2 takes the same approach as the US Environmental Protection Agency (EPA) in setting limits based solely on particle size, not chemistry.

ISO 18562-2 addresses possible contamination of the gas flow from the gas pathways that are then delivered to the patient. ISO 18562-2 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. It 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 conserving devices, oxygen concentrators, nebulizers, low pressure. Hose assemblies, humidifiers, heat and humidity exchangers, breathing gas monitors, breathing monitors, masks, mouthpieces, resuscitators, breathing tubes, breathing 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 18562-2 does not address contamination already present in gas supplied from gas sources when medical devices are in normal use.

Contamination to a 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 is not addressed by ISO 18562 (all parts).

and as part of its development, it aims to include the biological evaluation of the gas pathways of medical devices in a risk management process. This approach combines the review and evaluation of available data from all sources with the selection and application of additional tests as needed.

Among the services provided by our organization within the framework of material testing services, there are also ISO 18562-2 standard tests. Do not hesitate to contact our laboratory EUROLAB for your testing and certification requests.