We are pleased to announce that we have received accreditation from SWEDAC for our internally developed method for determining condensate volume of breathing gas pathways, adhering to ISO 18562-4. This significant achievement underscores Emmace’s dedication to providing cutting-edge biocompatibility testing of medical devices. This accreditation complements our existing accreditations for ISO 18562-2 (particulate matters, PM) and ISO 18562-3 (volatile organic substances, VOS), solidifying our comprehensive testing capabilities of breathing gas pathways in medical devices.

ISO 18562-4 Condensate

ISO 18562-4 is mandatory standard for medical devices (for example mouthpieces and breathing tubes), focusing on the quantification and risk assessment of exposure to condensate generated during patient use. Accurate measurement of the condensate volume, which can potentially enter the throat or the lungs region, is paramount for ensuring patient safety and meeting stringent regulatory requirements.

Emmace’s unique, validated method realistically simulates clinically relevant conditions. This allows for the precise determination of condensate volume, providing medical device manufacturers with the reliable data necessary for thorough risk assessment and evaluation if further testing is needed. All practical testing is conducted internally within our ISO 17025 accredited laboratory, ensuring efficient testing and reliable results. Also, the potential to collect condensates for measurement of or organics and inorganics is provided.

“This accreditation has been made possible thanks to the hard work and dedication of our knowledgeable medical device team. ,” says Anna Holmberg, CEO at Emmace. “Their scientific expertise and commitment to quality have enabled us to develop a leading-edge solution for ISO 18562-4 testing. We are proud to offer our clients this valuable service, reinforcing our position as a trusted partner in evaluating medical device biological safety.”

Learn more about our accredited testing services and how we can support your compliance efforts.