YY/T 1815-2022 in English

This standard establishes a framework for assessing the biocompatibility of medical device components using the toxicological concern threshold (TTC) approach. It provides guidance on the application of TTC principles to evaluate the potential biological risks associated with materials used in medical devices. The document outlines procedures for identifying and assessing substances that may pose a risk to human health when used in medical devices. It also includes criteria for determining the acceptable levels of chemical exposure based on toxicological data. The standard aims to ensure a consistent and scientifically based approach to the evaluation of biocompatibility across different types of medical devices. It covers the selection of relevant toxicological endpoints and the interpretation of toxicological data in the context of medical device use. The guidance is intended for use by regulatory authorities, manufacturers, and other stakeholders involved in the assessment of medical device safety.