GB/T 16886.17-2025 Biological evaluation of medical devices—Part 17:Toxicological risk assessment of medical device constituents

Scope

This document specifies the process and requirements for conducting a toxicological risk assessment of medical device components, as well as methods and guidelines for evaluating whether a component in contact with the human body poses significant harm. As described in ISO 10993-1, toxicological risk assessment can be conducted as part of the biological evaluation of the final product. This document applies to chemical characterization information obtained in accordance with ISO 10993-18. It is necessary to conduct a toxicological risk assessment of component information or analytical chemical data (such as extractable or leachable data) to determine whether the toxicological risks associated with the components are negligible or acceptable. This document does not apply to situations where toxicological risks have been estimated by other means, such as: -- Components present in medical devices or extracted from medical devices, excluding substances of concern or excluded chemicals, whose representative patient exposure levels are below the relevant toxicological-based reporting thresholds (see Appendix E of GB/T 16886.18-2022 and the applicable requirements of ISO/TS 21726). -- New or modified medical devices that have been proven to be chemically or biologically equivalent to existing biocompatible or clinically established medical devices (see the applicable requirements of Appendix C of GB/T 16886.18-2022). This document also does not apply to: -- Medical device components that do not come into contact with the human body (such as in vitro diagnostic reagents); -- Biological risks associated with the physical interaction of medical devices with the human body (e.g., mechanical force, energy, or the application of modified surface morphologies) under the premise that the chemical interaction remains unchanged; -- Active pharmaceutical ingredients in drug-device combination products or biological components in device-biologic product combination

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