New York, USA – April 25, 2022 – STEMart, a provider of integrated medical device CRO services dedicated to medical device and diagnostic clinical development, expands its Biocompatibility Testing services and introduces biocompatibility evaluation of breathing gas pathways in medical devices. This new testing follows the biocompatibility guidelines modified for medical devices and uses a solid scientific rationale.
Biocompatibility evaluation of breathing gas pathways in medical devices is a powerful tool for assessing 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 patient’s respiratory tract. STEMart now offers various services for Testing of Breathing Gas Pathways in medical devices.
For the biocompatibility standard, “Chemical Characterization of medical device materials”, part eighteen of the Biological evaluation of medical device standards(ISO 10993-18), gives 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 by analyzing water extracts or directly analyzing test items by heating the headspace.
ISO 18562 is a biocompatibility assessment standard for materials or medical devices with breathing gas pathways. It provides instructions for E/L extraction using purified water to simulate humidification vapor condensate, and VOC analysis for VOCs emitted in a gas stream under simulated use conditions (temperature, flow rate, duration) by GC/MS method, and particulates matter analysis of PM2.5 and PM10 emissions. Notably, the choice of sampling flow rate and temperature should be clinically relevant.
STEMart now 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. For example, STEMart can measure particulate matter emitted from medical equipment, flowing clean and dry air over the test material and collecting particulates from the output, and calculating PM2.5 and PM10 particle levels and recording minimum, maximum and average particle concentrations.
As for VOC analysis with Gas Chromatography Mass Spectrometry (GC/MS), STEMart offers two options for collecting and sampling VOCs: thermal desorption tube/can method and stainless steel SUMMA can method. VOCs are collected by directing clean, dry air through the test material in a controlled environment. Subsequently, particulate matter is sampled from the output. VOCs in gas samples ca be analyzed by GC/MS. VOC concentrations are reported in µg/m3. CO, CO2 and ozone can also be analyzed.
If you have additional questions about biocompatibility evaluation of breathing gas pathways in medical devices or if you would like to find out more about the medical device development service, please visit https://www.ste-mart.com.
STEMart is an industry-leading eCommerce platform with an expanded global footprint and has a broad portfolio of more than 10,000 products. It aims to provide best-in-class lab materials, medical instruments and consumables, excellent technologies, and high-quality services to global customers in the fields of science, technology, and engineering, from the discovery stage towards the manufacturing process. STEMart is dedicated to making research and biotech production simpler and safer, and through that to accelerate access to better health for people everywhere.