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  • BSI
    BS EN ISO 10993-17:2023 Biological evaluation of medical devices - Toxicological risk assessment of medical device constituents
    Edition: 2023
    $538.63
    / user per year

Description of BS EN ISO 10993-17:2023 2023

This document specifies the process and requirements for the toxicological risk assessment of medical device constituents. The methods and criteria used to assess whether exposure to a constituent is without appreciable 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 obtained in line with ISO 10993-18. When a toxicological risk assessment of either the compositional information or analytical chemistry data (e.g. extractable data or leachable data) are required to determine whether the toxicological risks related to the constituents are negligible or tolerable. 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 or excluded chemicals, that are present in or extracted from a medical device at an amount representative of patient exposure below a relevant, toxicologically-based reporting threshold (see applicable requirements in 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 applicable requirements in 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); —    biological risks associated with physical interactions of the medical device with the body (i.e. application of mechanical forces, energy or surface morphology, etc.), provided that the chemical exposure is not changed; —    active pharmaceutical ingredients of device-drug combination products or biologic components of device-biologic combination products as additional regulatory considerations can apply; —    exposure to a particular constituent that arises from sources other than the device, such as food, water or air.

Standard NumberBS EN ISO 10993-17:2023
TitleBiological evaluation of medical devices - Toxicological risk assessment of medical device constituents
StatusDefinitive
Publication Date2023-11-23
ReplacesBS EN ISO 10993-17:2009
Identical National Standard OfEN ISO 10993-17, ISO 10993-17
DescriptorsToxicology, Toxic materials, Biological analysis and testing, Leaching, Hazards, Medical equipment, Safety measures, Risk assessment, Toxicity, Statistical methods of analysis
ICS11.100.20 Biological evaluation of medical devices
CommitteeCH/194
ISBN978 0 539 01332 0
PublisherBSI
Pages80

The following editions for this book are also available...

About BSI

BSI Group, also known as the British Standards Institution is the national standards body of the United Kingdom. BSI produces technical standards on a wide range of products and services and also supplies certification and standards-related services to businesses.
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