Biocompatibility Evaluation of Breathing Gas Pathway Devices according to ISO 18562-2 and ISO 18562-3
Testing and determination of Particulate Matter (PM) and Volatile Organic Compounds (VOC) according to ISO 18562-2 and ISO 18562-3
According to ISO 18562-2 &-3 it is necessary to determine the amount of particles and VOC that are emitted from the medical device during usage. Emmace offers accredited analysis for both of these tests. Particles and VOC emitted from the device are collected during customized settings accounting for usage time, airflow, and temperature.
We also provide collection and quantification of Iso-cyanates that are released from medical devices using a unique methodology.
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 Volatile Organic Compounds, VOCs.
In addition we offer expert interpretation of inhalation toxicological 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 ISO 17025:2017.
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.
