Testing and determination of condensate according to ISO 18562-4
Why is ISO 18562-4 testing important?
ISO 18562-4 addresses the critical need for quantifying and assessing the risks associated with condensate produced during patient use, which can potentially enter the lungs or the throat region depending on the device. Accurate measurement of the condensate volume is essential for ensuring patient safety, meeting regulatory requirements and making it possible to estimate the exposure to substances in the condensate.
Emmace’s Solution
Our unique, validated method simulates use under clinical conditions within our state-of-the-art laboratories, enabling determination of condensate volume. This provides medical device manufacturers with the data on condensate volumes formed which is needed for a thorough risk assessment according to ISO 18562-4. All practical testing is conducted internally in our labs, ensuring efficient and reliable results. Sample setup is made in close contact with the customer to ensure as clinically relevant testing as possible.
Benefits of Choosing Emmace
- Accredited Expertise: Our ISO 17025 accreditation from SWEDAC guarantees the highest quality and reliability in testing procedures.
- Comprehensive Testing: We offer a complete suite of biocompatibility testing services, including ISO 18562-2, ISO 18562-3, and ISO 18562-4, including a preliminary toxicological evaluation according to ISO 18562-1.
- Trusted Partner: Emmace is committed to providing trustworthy and transparent services. We work closely with our clients, offering support and guidance.
Emmace holds ISO 17025 accreditation from SWEDAC
Emmace holds ISO 17025 accreditation from SWEDAC for our internally developed method to determine condensate volume, in accordance with ISO 18562-4. This accreditation complements our existing accreditations for ISO 18562-2 (particulate matters) and ISO 18562-3 (volatile organic compounds), solidifying our position as a trusted partner for medical device with indirect contact with the gas pathway biocompatibility testing. Our testing follows ISO18562:2024.
Contact us to discuss your specific testing requirements and learn how Emmace can support your ISO 18562-4 compliance.
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.
