ISO 18562 is the standard for biocompatibility evaluation of a material or medical device with a breathing gas pathway. When the gas pathway is expected to contact a patient via the respiratory tract, it is necessary to evaluate contaminants from the air emitted from the device for Volatile Organic Compounds (VOCs) and particulate matter. Inorganic gasses may also be sampled.
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Particulate matter is collected by directing clean, dry air through the test article and sampling particulates from the output using a light scatter laser photometry analyzer. PM2.5 and PM10 particulate matter levels are monitored and the minimum, maximum, and average particulate concentration will be reported.
Volatile Organic Compounds (VOCs) are collected by directing clean, dry air through the test article in a controlled environment. Gas samples are analyzed for VOCs by gas chromatography-mass spectometry (GC/MS) per EPA Method TO-15. The concentration of VOCs in µg/m3 is reported. CO, CO2, and Ozone may also be analyzed per sponsor request.
The flow-rate and temperature for sampling chosen should be clinically relevant. The medical device should be a final, finished device that has been subjected to the 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 for interpretation and correlation of data to patient safety. A Biological Evaluation Report (BER) is recommended after testing for justification of testing, interpretation of the data and overall safety conclusions. All are offered at Nelson Labs. For more information refer to Risk Assessments.
If you have additional questions about ISO 18562, or would like to consult with the experts at Nelson Labs, just send us a request or call us at +1 (801) 290-7500.
