ISO 18562-4 Condensate Testing: Ensuring Safety in Breathing Gas Pathways
Accurately quantify condensate and secure regulatory compliance together with one of Scandinavia’s leading biocompatibility test labs.
For medical devices with breathing gas pathways, the formation of condensate presents a unique patient safety risk. ISO 18562-4 mandates the evaluation of this condensate, as it can potentially enter the patient’s lungs or throat, carrying leached substances from the device material.
Accurate measurement of this condensate is essential for meeting stringent MDR and FDA 510(k) requirements. Emmace provides a unique, validated, and ISO 17025 accredited method for determining condensate volume, giving you the precise data needed to confidently submit your regulatory dossier.
For useful, step-by-step guidance on interpreting the ISO 18652-4 standard, please refer to Emmace Insight article.
The Emmace Advantage: Accredited, Clinically Relevant Testing
Our ISO 17025 accredited testing (updated to ISO 18562:2024) provides the rigorous data necessary for a complete risk assessment.
- Clinical Simulation: We don’t rely on generic setups. Our state-of-the-art laboratory simulates use under real-world clinical conditions, ensuring the condensate determined volume is highly accurate for your specific device.
- Customized Sample Setup: As a specialized, agile CRO, we work in close contact with you to tailor the testing setup, ensuring excellent clinical relevance.
- Complete Biocompatibility Suite: Condensate volume testing is just one piece of the puzzle. We offer a comprehensive suite of accredited services, including ISO 18562-2 (PM) and ISO 18562-3 (VOS), making us your primary partner for respiratory device testing.
Beyond the Data: Toxicological Evaluation
Data is only valuable if you understand its implications. Gathering the condensate volume is the critical first step, but it must be followed by a thorough risk assessment.
Certified Nordic Quality Assurance
Emmace is an independent CRO laboratory fully accredited by SWEDAC (national accreditation body for Sweden) according to ISO/IEC 17025:2018.
- Accreditation Number: 10501
- Location: Lund, Sweden (Medicon Valley)
Ready to secure your ISO 18562-4 compliance?
Contact our experts to discuss your specific testing requirements and learn how our validated methods can accelerate your path to market.
