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.

Biocompatibility evaluation of breathing gas pathway devices

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.

Emmace is accredited by SWEDAC (national accreditation body for Sweden) according to ISO17025:2017.
The accreditation certificate can be viewed here and more information can be found on the Swedac website.
Emmace accreditation number is: 10501. Emmace laboratory is located in Lund, Sweden.

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