ISO 18562 BIOCOMPATIBILITY EVALUATION OF BREATHING GAS PATHWAYS IN HEALTHCARE APPLICATIONS SERVICE.

Biocompatibility is an important assessment item in the risk management process of medical devices. However, the ISO 10993 standard for breathing tube materials for medical applications does not adequately solve the biological assessment of breathing tubes. Using the ISO 10993 test method, the breathing tube materials of medical applications that may cause indirect contact and the medical device directly in contact with body tissues are subjected to the same test conditions, resulting in excessive evaluation of the tested breathing tubes or no possible harmful substances Detected. It is clearly mentioned in ISO 10993-1:2018 that for breathing circuit components in indirect contact with the patient, what should use the ISO 18562 standard for biocompatibility assessment. In accordance with the ISO 18562-1 general principle of biocompatibility procedure, the assessment of respiratory pipeline contaminants in medical applications will use the expected length of use to release particulate matter and organic volatiles from gas pipelines, parts, and accessories. The chemical analysis test should be conducted on whether the condensed water generated by the respirator during use has the appearance of leaching of the product. Based on the above analysis, the respirator toxicology analysis and evaluation can be further carried out for the user.

SGS can provide the following related services for the ISO 18562 standard:

• Particulate matter released from respirator products (ISO 18562-2)
• Analysis of Volatile Compounds (VOCs) Released from Respirator Products (ISO 18562-3)
• Analysis of extracts in condensed water (ISO 18562-4)
• Toxicological Analysis and Evaluation of Extracts in Condensed Water