prEN ISO 10993-17

This part of the ISO 10993 specifies the process and requirements for the toxicological risk assessment of medical device constituents to be used within the biological evaluation of the final product described in ISO 10993-1, which includes the methods and criteria used to assess if exposure of a chemical constituent(s) is without appreciable harm(s). The process described in this document is intended to apply after chemical characterization compositional profiling is performed as required by ISO 10993-18, and thus a toxicological risk assessment of either the compositional information, extractable data or leachable data are required to conclude if the risks related to the constituents are acceptable or not. The process described in this document is not intended to apply to circumstances where the toxicological risk has been estimated by other means, such as: — constituents, excluding cohort of concern/excluded chemicals, that are present or extracted at an amount representative of patient exposure below a relevant, toxicologically-based reporting threshold (see ISO 10993-18:2020, Annex E and ISO/TS 21726); — a new or changed medical device for which chemical or biological equivalence has been established with an existing biocompatible or clinically established medical device (see ISO 10993-18:2020, Annex C). The process described in this document is also not applicable to — medical device constituents that do not contact the body (e.g., in vitro diagnostics), — all biological risks applicable to a medical device (e.g., harm(s) that result(s) from physical interaction (i.e., application of mechanical forces, energy, or surface morphology, etc.) of the medical device with the body), provided that the chemical exposure is unchanged, — active pharmaceutical ingredients of device-drug combination products or biologic components of device-biologic combination products as additional regulatory considerations may apply, — exposure to a particular chemical constituent that arises from sources other than the device, such as food, water, or air. This document does not address the potential for exposure from such sources