Satisfying ISO 18562 and FDA Biocompatibility Regulatory Requirements for Breathing Gas Pathways in Health Care Application

In March 2017, the new ISO 18562 standard series was released, comprising four parts that address the biocompatibility assessment of medical device materials used in gas pathways. This standard series introduces general principles for evaluating the safety of these materials, focusing on additional concerns such as volatile organic compounds (VOCs), particulates, and leachables in condensate.

The US FDA has recently recognized ISO 18562 parts 2 and 3 in their entirety, along with portions of parts 1 and 4. This recognition underscores the importance of the ISO 18562 series as a complementary standard to the ISO 10993 suite, providing supplemental testing and considerations for comprehensive biological safety evaluations.

The ISO 18562 series should be integrated into a three-step process for overall biological safety evaluation:

1. Initial Risk Assessment: This step involves introducing the device, materials, processing methods, and patient contact points. It also includes identifying areas of risk and outlining mitigation steps.
2. Testing and Risk Assessments: This phase involves conducting the necessary tests to evaluate VOCs, particulates, and leachables, followed by risk assessments based on the results.
3. Summary Report: The final step is compiling a summary report that concludes the device is biocompatible, based on the initial risk assessment and testing results.

This presentation will provide an in-depth look at the ISO 18562 standard series, explaining how it supplements the ISO 10993 standards. Attendees will learn about the specific requirements for assessing gas pathway materials, the types of tests involved, and how to incorporate these standards into their biocompatibility evaluation processes.

This webinar is essential for professionals involved in the design, testing, and regulatory compliance of medical devices with gas pathways. By attending, participants will gain a comprehensive understanding of the ISO 18562 standards and how to apply them effectively to ensure the safety and compliance of their devices.