NF EN ISO 10993-17, S99-501-17 (11/2023)

This document specifies the process and requirements for assessing the toxicological risk of constituents of medical devices. The methods and criteria used to assess whether exposure to a constituent does not cause significant harm are also specified. The toxicological risk assessment can be part of the biological evaluation of the final product, as described in ISO 10993-1. The process described in this document applies to chemical characterization information collected in accordance with ISO 10993-18. When a toxicological risk assessment based on compositional information or analytical chemistry data (e.g. data on extractables or leachables) is necessary to determine whether the toxicological risks associated with the constituents are negligible or tolerable . The process described in this document is not intended to apply to cases where toxicological risk has been estimated by other means, for example: — constituents, excluding the cohort of concern or chemicals excluded, which are present in or extracted from a medical device at a quantity representative of patient exposure below a relevant reporting threshold, based on toxicological criteria (see the applicable requirements of ISO 10993-18:2020, Annex E and ISO/TS 21726); — a new or modified medical device for which chemical or biological equivalence has been established with an existing biocompatible or clinically established medical device (see the applicable requirements of ISO 10993-18:2020, Annex C). Furthermore, the process described in this document does not apply to: — constituents of medical devices which do not come into contact with the body (for example, in vitro diagnostic devices); — biological risks associated with physical interactions of the medical device with the body (i.e. the application of mechanical forces, energy or surface morphology, etc.), provided that the exposure chemical remains unchanged; — active pharmaceutical ingredients of device/drug combination products or biological components of device/biological substance combination products, depending on additional regulatory considerations that may apply; — exposure to a particular constituent from sources other than the device, such as food, water and air.
(Automatic translation from French)