Updates to USP Class VI Impacting Medical Device Materials
Автор: Nelson Labs
Загружено: 2025-08-22
Просмотров: 159
Recent updates to USP Class VI testing and its role in medical device material qualification have reshaped how manufacturers evaluate and justify material biocompatibility. Traditionally used as a benchmark for material safety, USP Class VI is now recognized as a limited scope test that must be integrated into a broader, risk-based framework aligned with ISO 10993. This session will explore the key changes, clarify misconceptions, and provide practical guidance for incorporating USP Class VI testing into a modern biological evaluation strategy. Attendees will gain insights into how regulatory expectations have evolved, what the changes mean for materials testing and selection, and how to ensure compliance with both U.S. and global standards.
What you’ll learn by attending:
The updated scope and limitations of USP Class VI testing
How USP Class VI aligns (and differs) from ISO 10993 biocompatibility requirements
When and how to appropriately use Class VI data in regulatory submissions
The regulatory implications of relying solely on USP Class VI for material safety
Practical tips for updating internal procedures and test strategies in response to the changes
Доступные форматы для скачивания:
Скачать видео mp4
-
Информация по загрузке:
