ISO 18562 Testing for Medical Respiratory Devices: Secure Your Regulatory Approval
Navigate the complexity of the ISO 18562:2024 requirements with one of Scandinavia’s leading test lab and biocompatibility experts.
The regulatory landscape for medical devices is evolving rapidly. Whether you are developing ventilators, nebulizers, anesthesia equipment, or breathing masks, proving the safety of your breathing gas pathways is critical for MDR and FDA 510(k) compliance.
At Emmace Consulting, we specialize in the collection, identification, and precise measurement of particulate matter (PM) and volatile organic substances (VOS) emitted by medical devices during use. We also can determine the released volume of condensate released during simulated usage. By partnering with us, you gain an extended quality department that helps you avoid costly regulatory delays and ensures a faster time-to-market.
Our ISO 17025 Accredited Test Services (Updated to ISO 18562:2024)
We offer an extensive suite of accredited services for respiratory device testing:
ISO 18562-2: Determination of Particulate Matter (PM)
We accurately measure and quantity particulate matter (0.2 µm – 10 µm) emitted from your medical device.
ISO 18562-3: Identification and Quantification of Volatile Organic Substances (VOS)
Beyond standard VOS screening, our advanced analytical lab offers specialized collection and quantification of highly reactive compounds, including isocyanates and aldehydes (e.g., formaldehyde, acetaldehyde) that can all be tested at the same time. This rigorous approach completely fulfills the VOS requirements according to the standard.
ISO 18562-4: Determination of Released Condensate Volume
Accredited testing to measure condensate formation within breathing gas pathways.
A Customized, Uncomplicated Testing Approach
As a specialized boutique expert CRO, our flexibility is our strength. We don’t just run standard scripts; we mimic real-world clinical conditions. Particles and VOS emitted from your devices are collected using customized settings that precisely account for your specific usage time, airflow rates, and temperature.
Need non-accredited analysis? We also perform specific testing upon request.
From Raw Data to Regulatory Success
Gathering the data is only the first step. With many years of combined experience, our senior experts help you understand what the data means for your submission.
In addition to laboratory testing, 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. We translate complex chemical characterizations into clear, actionable safety assessments.
Certified Nordic Quality Assurance
Emmace is an independent CRO laboratory fully accredited by SWEDAC (national accreditation body for Sweden) according to SS-EN ISO/IEC 17025:2018
- Accreditation Number: 10501
- Location: Lund, Sweden
Ready to discuss your testing needs?
Connect with our experts to design a streamlined, cost-effective testing plan for your device.