November 8, 2017
Satisfying ISO 18562 and FDA Biocompatibility Regulatory Requirements for Breathing Gas Pathways
In March of 2017, the new ISO 18562 standard series was released. This standard covers the general principles regarding biocompatibility assessment of medical device materials which comprise the gas pathway. This standard greatly increases the scrutiny for gas path devices and their required tests. This presentation will cover the required biological endpoints and the unique test methods to test these devices.