Toxicological risk assessment (TRA) of medical devices according to ISO 10993-17

ISO 10993-17 provides a structured approach to establishing safe exposure levels for chemicals released by medical devices during clinical use. A toxicological risk assessment in accordance with the standard is typically required if extractable and leachable substances are discovered during chemical characterization (ISO 10993-18) in concentrations above the analytical evaluation threshold (AET).

A comprehensive risk assessment is created using toxicological data from existing literature, or mathematical tools when data on particular substances are unavailable. 

The assessment will include:

  • A summary of the toxicological profile of substances flagged from the device's chemical characterization and determination of their respective permissible exposure limits.

  • A calculation of the margin of safety between actual patient exposure and permissible exposure limits, considering various toxicological endpoints.

  • A final assessment of whether a leachable poses a significant toxicological risk, including recommendations on ensuring compliance with safety thresholds.

The displayed starting price includes the evaluation of one extractable chemical and the reporting fee. Typically, multiple substances are evaluated during the risk assessment, but the price per chemical is significantly lower for additional chemicals.

The extent of the required toxicological evaluation depends on the results of the ISO 10993-18 chemical characterization, which we can also offer if not yet completed.

Contact our experts using the form below to get a tailored quote.

Required sample quantity
Data from ISO 10993-18
Available quality systems
Accredited testing laboratory

Price

Starting from (Excl. VAT):
1,395 €per sample

We also charge a 97 € service fee per order.

Large batches of samples are eligible for discounts.

Questions? We're happy to help.

Questions? We're happy to help.

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Answering the following questions helps us prepare an offer for you faster:

  • What is the intended use, body contact site, and contact duration of the medical device?

  • Which material(s) does the device consist of?

  • Has chemical characterization (ISO 10993-18) already been completed, or would you like us to include it in the quote?

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