The End of an Era: USP Class VI Is Being Replaced

The United States Pharmacopeia (USP) has moved away from traditional Class VI testing. Once regarded as the gold standard for material safety, USP Class VI is now acknowledged as offering limited insight and must be incorporated into a comprehensive, risk-based evaluation strategy aligned with ISO 10993.

This presentation examines the updated USP chapters (1031, 87, and 88), which introduce a risk-based approach to biocompatibility assessment, and provides a brief overview of the revised test methods. Discover what these changes mean for material qualification, regulatory compliance, and the future of testing strategies in both medical devices and pharmaceutical packaging.

Webinar Language: English

For any information you can contact us at: medical-device@bpt.eurofinseu.com

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