[Discussion on the design approach and results evaluation key points of repeated exposure systemic toxicity tests for absorbable medical devices].

Abstract

Compared to non-absorbable medical devices, the design and evaluation of repeated exposure systemic toxicity tests for absorbable medical devices present unique challenges. This article discusses the special considerations for conducting such tests on absorbable medical devices. Based on regulatory documentation, scientific literature and practical experience, and focusing on the degradation and metabolic characteristics of absorbable medical devices, the analysis summarizes personalized test de