ISO 18562 Series 2024: Essential Updates And Testing Requirements

By Kevin Wells, Eurofins Medical Device Services

Ensuring the safety and performance of medical devices before they reach patients requires comprehensive testing and qualification to meet increasingly rigorous regulatory expectations. ISO 18562:2024 establishes updated requirements for evaluating biological risks associated with gas pathway medical devices, including exposure to particulate matter, volatile organic compounds (VOCs), and leachable chemicals. The standard also emphasizes assessing the effects of aging, environmental conditions, and material degradation to ensure devices maintain their safety and performance throughout their intended shelf life.

With the release of ISO 18562:2024, manufacturers should carefully review existing products and development programs to determine whether additional testing or risk assessments are required. This is particularly important for devices that have undergone material, design, supplier, or manufacturing process changes. Partnering with an experienced testing laboratory can help manufacturers navigate the updated requirements, identify compliance gaps, conduct the necessary evaluations for gas pathway devices, and generate the data needed to support regulatory submissions. Taking a proactive approach to compliance can help minimize regulatory risks, avoid submission delays, and ensure continued market access.