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Norm

ISO 10993-17:2023

Ausgabedatum: 2023 09 13

Biological evaluation of medical devices — Part 17: Toxicological risk assessment of medical device constituents

This document specifies the process and requirements for the toxicological risk assessment of medical device constituents. The methods and criteria used to assess whether...
Gültig
Herausgeber:
International Organization for Standardization
Format:
Digital | 65 Seiten
Sprache:
Englisch

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 

ISO 10993-17:2023
2023 09 13
Biological evaluation of medical devices — Part 17: Toxicological risk assessment of medical device ...
Norm
ISO 10993-17:2002
2002 11 27
Biological evaluation of medical devices — Part 17: Establishment of allowable limits for leachable ...
Norm