[Development Status and Evaluation Strategy Considerations on In Vitro Alternative Methods for Skin Sensitization Testing of Medical Devices].

Tests for skin sensitization are commonly used methods for evaluating the sensitization of medical devices. With the development of animal welfare and scientific technology, various toxicology evaluation tools such as in vitro experiments and non-testing toxicity prediction methods are gradually used internationally to evaluate skin sensitization. The development and application of in vitro alternative methods for skin sensitization tests of medical devices has become an inevitable trend in the field of biological evaluation of medical devices. This article introduces the in vitro and genomic methods for identifying skin sensitization potential based on the adverse outcome pathway (AOP) of skin sensitization, which have been validated in the current OECD 442 Trial Guidelines. This article analyzes their respective experimental principles, scope of application, and limitations in their application to medical device testing. Based on the characteristics of medical devices themselves, it proposes a strategy for evaluating in vitro skin sensitization testing of medical devices.