Biological evaluation of gas pathways in medical devices

The ISO 10993 series provides a framework for the biological evaluation of all medical devices (MDs) that come into direct or indirect contact with the patient’s body. But for many medical devices, biological evaluation doesn’t stop there.

In fact, medical devices incorporating a gas-transport system whose intended use involves the patient inhaling gas, or the risk that the gas circulating within it will be inhaled by the latter, must undergo special treatment for their biological
evaluation. These include emergency ventilators, reanimation equipment, breathing tubes, nebulizers and inhalers, as well as mouthpieces, nosepieces, masks, and personal respiratory protection equipment.

This newsletter outlines the methodology for assessing the biological risk of gas pathways, as set out in the ISO 18562 series, revised in 2024.

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