ONORM EN ISO 10993-17:2024

Biological evaluation of medical devices - Part 17: Toxicological risk assessment of medical device constituents (ISO 10993-17:2023)

This document specifies the procedure and requirements for the assessment of the toxicological risk of components of medical devices. In addition, procedures and criteria for assessing whether exposure to a component does not cause significant harm are established. The toxicological risk assessment can be part of the biological assessment of the final product as described in ISO 10993-1. The procedure described in this document is applicable to the chemical characterization information obtained according to ISO 10993-18. Where a toxicological risk assessment of either compositional information or analytical chemistry data (e.g. extractable or leachable substance data) is required to determine whether the toxicological risks associated with the components are negligible or tolerable . The procedure described in this document is not intended for cases where the toxicological risk has been estimated by other means, such as: E.g.: - Components, excluding the cohort of substances of concern or excluded chemicals, that are present in or extractable from a medical device in an amount representative of patient exposure below a relevant, toxicologically based reporting threshold; - a new or modified medical device for which chemical or biological equivalence has been established with an existing biocompatible or clinically established medical device. In addition, the procedure described in this document is not applicable to: - components of medical devices that do not come into contact with the body (e.g. in vitro diagnostic devices); - biological risks resulting from physical interactions with the body (i.e. through the application of mechanical forces, energy or due to surface morphology, etc.), provided that the chemical exposure is unchanged; - medicinally active components of product-drug combinations or biological components of product-biologic combinations, as additional legal considerations may apply here; - exposure to a specific ingredient from sources other than the product, e.g. B. from food, water or air.