Biocompatibility analysis of respiratory medical devices according to ISO 18562
Regulations on the Biocompatibility evaluation of medical devices (ISO 10993-1:2018) highlight the need for manufacturers to measure chemicals released from their respiratory devices’ components into the breathing gas pathways of patients.
ISO 18562 (recognised by the Food and Drug Administration) stipulates how these measurements should be carried out, including tests for extractables and leachables, particulate matter and volatile organic compounds (VOC)s.
This webinar focuses on best practice in sampling and analysis of VOCs from respiratory medical devices.
What you will learn:
- Requirements for ISO 18562.
- How to sample VOCs from respiratory medical devices.
- Analytical methodology required for ISO 18562.
- How to reach lower detection limits for volatile extractables and leachables.