Biocompatibility evaluation of breathing gas pathways in medical devices is a powerful tool for the evaluation of contaminants from the air emitted from the device for Volatile Organic Compounds (VOCs) and particulate matter when the gas pathway is intended to contact a patients’ respiratory tract.

Standard for Biocompatibility Evaluation of Breathing Gas Pathways in Medical Device

"Chemical Characterization of medical device materials", part eighteen of the Biological evaluation of medical device standards(ISO 10993-18), gives out the general guidance for E/L testing including polar, semi-polar, and nonpolar solvents measure leaching of organic compounds. It also outlines that VOCs can be determined either by an analysis of aqueous extracts or direct analysis of test articles by heated headspace.

ISO 18562, the standard for biocompatibility evaluation of material or medical device with a breathing gas pathway, presents instructions for E/L extraction with purified water to simulate humidified vapor condensate, VOC analysis for VOCs emitted in a gas stream under simulated use conditions(temperature, flow rate, duration) with GC/MS method, and particulates analysis for emissions of PM2.5 and PM10. It’s noteworthy that the flow rate and temperature for sampling chosen should be clinically relevant.

Our Testing of Breathing Gas Pathways Services

· Medical devices with breathing gas pathways covered by our service as follows:

· Particulate matter measurement for those emitted from the medical device.

Flowing clean and dried air through the test material and collecting particulates matter from the output. Calculating the particulate matter levels of PM2.5 and PM10 and recording the minimum, maximum, and average particulate concentration.

· VOC analysis with Gas Chromatography Mass Spectrometry (GC/MS).

We have two options for collecting and sampling VOCs: Thermal Desorption Tubes/Canisters Method and Stainless Steel SUMMA Canister Method. VOCs are collected by leading clean and dry air through the test material in a controlled environment. Subsequently, sampling particulates matter from the output. Gas samples are analyzed for VOCs by GC/MS. The concentration of VOCs in µg/m3 is reported. CO, CO2, and Ozone may also be analyzed.

· Leachables analysis in condensate with Gas Chromatography Mass Spectrometry (GC/MS) and Inductively Coupled Plasma (ICP) method.

After collection of leachables, we provide determination of the metal ion concentrations with pharmacopeia methods, and identification and quantification of organic impurities with GC/MS.

· Interpretation of inhalation toxicity data relevant to breathing gas pathways for the medical device.

STEMart offers biocompatibility evaluation of material or medical device with a breathing gas pathway utilized modern analytical techniques and instrumentation, following the biocompatibility guidelines modified for medical devices and using a solid scientific rationale. If you have additional questions about the Testing of Breathing Gas Pathways Services or would like to find out more about our services, please feel free to contact us.