Updates For Breathing Gas Pathways

ISO 18562:2024 introduces significant changes that are reshaping testing strategies, risk assessments, and regulatory compliance expectations for medical devices.

In this short video, Eurofins experts break down the latest updates to the standard, including the impact on existing devices, evolving regulatory strategies, and key considerations for FDA submissions ahead of the July 5, 2026, deadline.

Learn about the revised testing requirements, the expanded scope to include personal protective equipment (PPE), new evaluations for aldehydes and very volatile organic compounds (VVOCs), and the increasing importance of lifecycle management and post-market surveillance. The video also explores the alignment of ISO 18562-4 with ISO 10993, providing manufacturers with practical insights to help navigate changing compliance requirements with confidence.