Emmace Consulting submit a unique and advanced method for ISO accreditation
We’re thrilled to announce that our in-house developed method for condensate testing, according to the standard ISO 18562-4:2024 Biocompatibility evaluation of breathing gas pathways in healthcare applications Part 4: Tests for leachables in condensate, has been submitted for ISO 17025 accreditation.
Our innovative approach focuses on determining the condensate that can reach patients during simulated use. Whether it’s through swallowing from the mouth entrance or direct reaching the lung (for tracheostomized patients), our method ensures accurate assessment of the condensate volume. If the condensate volume formed is not more than 0.1 ml in 24 hours, further testing isn’t necessary according to the standard.
How It Works:
- We’ve built a complete lung simulator with realistic conditions (temperatures, humidity, and breathing patterns) in our Emmace laboratories.
- The test device is meticulously positioned within the simulator, mimicking real-world scenarios.
- During the prescribed usage time, we experimentally measure the amount of released condensate that enters the patient, as per ISO 18562-4.
- If the condensate formed is not more than 0.1 ml in 24 hours, no further testing is needed.
Why It Matters:
- Our method provides a rapid yes/no assessment, making it an excellent initial test.
- For devices releasing less than 0.1 ml, it eliminates the need for lengthy and complex toxicology evaluations.
Stay tuned for the full accreditation approval within the next 6 months!
Learn more about Emmace’s cutting-edge test services here https://www.emmace.se/analytical-services/medical-device-testing/
