UL Japan Official site

[Online Seminar] Biological Evaluation Process of Medical Devices for Breathing Gas Pathways (ISO 18562)

UL Japan

In the biological evaluation of medical devices, compliance with ISO 10993 is required, and among them, medical devices with a respiratory gas pathway are subject to ISO 18562. With the revision of ISO 10993-1 in 2018, the importance of biological evaluation based on biocompatibility risk has increased not only in Europe and the United States but also in Japan. For medical devices with a respiratory gas pathway, the 2020 version of ISO 18562 has been issued, and inquiries regarding the relationship with ISO 10993 have also been increasing. In this seminar, we will explain the relationship between ISO 10993 and ISO 18562, as well as an overview of the tests required by the structure of ISO 18562. Additionally, we will introduce related services provided by UL. --------- Target Audience: - Regulatory affairs personnel from manufacturers of medical devices with a respiratory gas pathway - Individuals considering conducting biocompatibility evaluations for medical devices - Those interested in ISO 18562