EVS-EN ISO 10993-17:2023

Meditsiiniseadmete bioloogiline hindamine. Osa 17: Meditsiiniseadme osade toksikoloogilise riski hindamine

Kehtiv alates 01.12.2023
EN ISO 10993-17:2023; ISO 10993-17:2023
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ISO 10993-17 specifies the process and requirements for the toxicological risk assessment of medical device constituents to be used in the final product's biological evaluation (described in ISO 10993-1). It includes the methods and criteria used to assess if exposure to a chemical constituent is without appreciable harm.

The process described in this standard is intended to apply after chemical characterization compositional profiling is performed as required by ISO 10993-18. Thus a toxicological risk assessment of either the compositional information, extractable data or leachable data is required to conclude if the risks related to the constituents are acceptable or not.

The process described in ISO 10993-17 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 or extracted at an amount representative of patient exposure below a relevant, toxicologically-based 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 ISO 10993-17 is also not applicable to:

— medical device constituents that do not contact the body,
— all biological risks applicable to a medical device provided that the chemical exposure is unchanged,
— active pharmaceutical ingredients of device-drug combination products or biologic components of device-biologic combination products as additional regulatory considerations may apply,
— exposure to a particular chemical constituent that arises from sources other than the device, such as food, water, or air.

The text of ISO 10993-17:2023 has been approved in Europe as EN ISO 10993-17:2023 without any changes.

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