Biocompatibility Evaluation of Breathing Gas Pathway Devices according to ISO 18562-2 and ISO 18562-3
ISO 18562-2 and ISO 18562-3
ISO 18562 is the standard for biocompatibility evaluation of a material or medical device in in-direct contact with the breathing pathway. When the gas pathway is expected to connect the medical device and the respiratory tract of a patient, it is necessary to evaluate if contaminants, that can reach the patient, are emitted from the device. The contaminations can be particulate matter, Volatile Organic Compounds (VOC) and/or condensate that forms on the product and can reach the patient as droplets.
Emmace offers the following ISO 17025 accredited test services:
ISO 18562-2, Determination of particulate matter (PM) emitted from your medical device (0.2 µm -10 µm).
ISO 18562-3, Identification and quantification of emitted VOCs.
In relation to above we also offer expert interpretation of inhalation toxicity data relevant to breathing gas pathways for your device per ISO 10993-17 and ISO/TS 21726:2019.
A verified and unique method, based on the accredited set-up above, for collecting and quantifying the amounts of isocyanates released from medical devices is also provided as an analytical service.