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Norm
ÖNORM EN ISO 10993-17
Issue date: 2024 02 15
Biological evaluation of medical devices - Part 17: Toxicological risk assessment of medical device constituents (ISO 10993-17:2023)
This document specifies the process and requirements for the toxicological risk assessment of medical device constituents. The methods and criteria used to assess whether...
Valid
§ Legal References
Publisher:
Austrian Standards International
Format:
Digital | 86 Pages
Language:
German
| English
| Download GER/ENG
Optionally co-design standards:
ICS
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, toxicologicallybased reporting threshold;
- a new or changed medical device for which chemical or biological equivalence has been established with an existing biocompatible or clinically established medical device.
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.
ÖNORM EN ISO 10993-17
2024 02 15
Biological evaluation of medical devices - Part 17: Toxicological risk assessment of medical device ...
Norm
↖
ÖNORM EN ISO 10993-17
2009 09 15
Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable ...
Norm
ÖNORM EN ISO 10993-17
2003 06 01
Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable ...
Norm
Norm
Issue date :
2018 08 17
Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process (Corrected version 2018-10)
Norm
Issue date :
2020 01 13
Biological evaluation of medical devices — Part 18: Chemical characterization of medical device materials within a risk management process
Technische Regel
Issue date :
2019 02 01
Biological evaluation of medical devices — Application of the threshold of toxicological concern (TTC) for assessing biocompatibility of medical device constituents
Norm
Issue date :
2019 12 10
Medical devices — Application of risk management to medical devices