Emmace Consulting AB

Ventilators, anesthesia systems, CPAP devices, HMEs — any device that conditions or delivers breathing gas must prove it doesn't contaminate the air your patients breathe. ISO 18562-2 (Particulate Matter) and ISO 18562-3 (Volatile Organic Substances) define exactly what regulators expect — and the requirements got stricter in 2024. Emmace is one of Europe's few ISO 17025 accredited laboratories for both tests.We take pride in working very tight with the client in order to ensure correct test setup. Uniquely, we combine accredited analytical testing with expert inhalation toxicology interpretation — so you don't need to run between a chemistry lab and a consultant.

ISO 18562-3 asks the question: What volatile organic substances does your device release into the breathing gas during actual use — and are they safe to inhale? This test requires both advanced analytical chemistry (GC/MS identification and quantification) and the ability to interpret toxicological significance in the specific context of inhalation — not just extraction. Emmace offers ISO 17025 accredited ISO 18562-3 testing with VOS profiling, using VOS screening where also low molecular aldehydes and isocyantes can be analysed. We can also offer air sampling for all three tests simultaneously and get T0 on the same device. Our reports include expert interpretation of the released substances per ISO 18562-1,10993-17 and ISO/TS 21726:2019. One partner. One accredited result.

ISO 18562-2 measures the particulate matter your device releases into the patient's breathing gas under realistic use conditions. It sounds simple. But many device materials shed unexpected particles — and a generic testing lab may measure them without knowing what they mean for your specific device and your regulatory submission. Emmace provides ISO 17025 accredited ISO 18562-2 testing, updated to the 2024 standard. Measuring the release online with particle counters during test period combined with expert inhalation toxicology interpretation — so you know exactly where you stand before your notified body does. Don't let a particle count become a costly re-test.

Ventilators, anesthesia systems, CPAP devices, HMEs — any device that conditions or delivers breathing gas must prove it doesn't contaminate the air your patients breathe. ISO 18562-2 (Particulate Matter) and ISO 18562-3 (Volatile Organic Substances) define exactly what regulators expect — and the requirements got stricter in 2024. Emmace is one of Europe's few ISO 17025 accredited laboratories for both tests.We take pride in working very tight with the client in order to ensure correct test setup. Uniquely, we combine accredited analytical testing with expert inhalation toxicology interpretation — so you don't need to run between a chemistry lab and a consultant.

ISO 18562-3 asks the question: What volatile organic substances does your device release into the breathing gas during actual use — and are they safe to inhale? This test requires both advanced analytical chemistry (GC/MS identification and quantification) and the ability to interpret toxicological significance in the specific context of inhalation — not just extraction. Emmace offers ISO 17025 accredited ISO 18562-3 testing with VOS profiling, using VOS screening where also low molecular aldehydes and isocyantes can be analysed. We can also offer air sampling for all three tests simultaneously and get T0 on the same device. Our reports include expert interpretation of the released substances per ISO 18562-1,10993-17 and ISO/TS 21726:2019. One partner. One accredited result.

A failed or incomplete ISO 18562-4 test is more than just a technicality—it’s a major risk to your timeline. In our latest Emmace Insight, we break down how to ensure your data is rigorous, accredited, and submission-ready from day one. Learn how to generate condensate volume data through our unique, ISO 17025-accredited method. New: We’ve added a downloadable ISO 18562-4 Checklist to help you navigate the complexities of breathing gas pathway biocompatibility.