Biocompatibility Evaluation of Breathing Gas Pathway Devices according to ISO 18562-2 and ISO 18562-3
1. Testing and determination of Particulate Matter (PM) and Volatile Organic Compounds (VOC) according to ISO 18562-2 and ISO 18562-3
ISO 18562-2 and ISO 18562-3 require the measurement of particles and volatile organic compounds (VOCs) emitted by medical devices during use.
Emmace provides testing services for these parameters using accredited analytical methods and a unique testing approach.
Particles and VOCs emitted from the devices are collected by customized settings accounting for usage time, airflow, and temperature.
In addition to standard VOC screening testing, we offer specialized collection and quantification of isocyanates and aldehydes (e.g., formaldehyde, acetaldehyde) released from the medical devices.
Other non-accredited analysis
We can also perform non-accredited tests for amines upon request.
2. 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. VOC screening together with isocyanate and aldehyde target analysis fulfill the VOC requirements according to the standard.
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.
Emmace is accredited by SWEDAC (national accreditation body for Sweden) according to ISO 17025:2018.
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.
