ISO 18562 is the standard for the biocompatibility assessment of a respiratory tract material or medical device. When the gas path is expected to come into contact with a patient through the respiratory tract, it is necessary to evaluate the airborne contaminants emitted from the device for Volatile Organic Compounds (VOC) and particulate matter. Inorganic gases can also be exemplified.
Particulate matter is collected by directing clean, dry air through the test substance and sampling particles from the outlet using a light scatter laser photometry analyzer. PM2.5 and PM10 particulate matter levels are monitored and the minimum, maximum and average particle concentration is reported.
Volatile Organic Compounds (VOCs) are collected by directing clean, dry air through the test product in a controlled environment. Gas samples are analyzed for VOCs by gas chromatography-mass spectrometry (GC / MS) according to the EPA Method TO-15. Ug VOC concentration / m 3 is reported. CO, CO 2 and Ozone can also be analyzed upon sponsor request.
Flow rate and temperature for the sample chosen should be clinically relevant. The medical device must be a final, finished device subject to normal manufacturing, sterilization (if possible), packaging, and shipping and handling delays.
A Biological Evaluation Plan (BEP) is recommended prior to ISO 18562 testing to evaluate the product and provide recommendations on required testing. A Toxicological Risk Assessment is required to correlate and interpret data with patient safety. A Biological Evaluation Report (BER) is recommended for testing justification, interpretation of data, and overall safety conclusions. All EUROLABIt is offered at.
EUROLAB, with its highly expert team and internationally accredited laboratories, ISO 18562-Biocompatibility Assessment of Respiratory Gas Road Devices It performs all test, analysis, measurement, evaluation and report generation services completely and reliably.
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