ISO 18562-2 Respiratory Gas Routes in Healthcare Applications - Testing for Particulate Matter Emissions

EUROLAB, with its state-of-the-art accredited laboratories and expert team, provides precise and fast testing services within the scope of ISO 18562-2 testing. This standard specifies tests for particulate matter emissions from the gas paths of a medical device, its parts or accessories for the purpose of providing respiratory care in all environments or providing a substance to a patient through the respiratory tract.

The tests of this document aim to quantify particles from 0,2 µm diameter to 10 µm diameter emitted by the medical device, its parts or accessories into the respirable gas stream. 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 less 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, this document takes the same approach as the US Environmental Protection Agency (EPA) in setting limits based solely on particle size, not chemistry.

This document addresses possible contamination of the gas stream from the gas pathways that are then delivered to the patient.

This document is valid for the expected service life of the medical device in normal use and takes into account the effects of any intended treatment or reprocessing.

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; Not covered by ISO 18562 (all parts).

The tests described in this document are type tests . Type tests are performed on the final medical device , a component of the medical device , or a representative sample of the medical device , part or accessory under consideration . If representative samples are used (ie manufactured and processed using equivalent methods), consideration should be given to whether differences between the representative sample and the final medical device or component will affect test results . Testing of representative samples (manufactured and processed by equivalent methods) rather than the final medical device should be supported by a description of any differences between the representative sample and the final medical device and a detailed rationale as to why each difference is not expected to affect the biocompatibility of the final medical device.

This document does not address the biological evaluation of the surfaces of the 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 systems filters, Y-pieces, and 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 by this document.

This document does not address the contamination already present in gas supplied from gas sources when medical devices are in normal use .

EUROLAB assists manufacturers with ISO 18562-2 test compliance. Our test experts, with their professional working mission and principles, provide you, our manufacturers and suppliers, the best service and controlled testing process in our laboratories. Thanks to these services, businesses receive more effective, high-performance and quality testing services and provide safe, fast and uninterrupted service to their customers.