Toxicological Risk Assessment

Following an Extractables/Leachables (E&L) Study

ISO 10993-17

Toxicological Risk Assessment of Medical Device Constituents

If you have performed an extractables/leachables (E&L) study to complete the chemical characterisation process of your device, then a toxicological risk assessment (TRA) of the findings from the E&L study may be required following the process described in ISO 10993-17.

This process is intended to yield information which is useful in the overall biological risk assessment of the final product:

  • Whether constituents extracted from the medical device are at a quantity that could be a potential source of harm to health
  • A toxicological risk estimate based on the tolerable intake, or tolerable contact level, and worst-case estimated exposure dose for each constituent.
  • A worst-case estimated exposure dose for each constituent and subsequent toxicological risk estimation.
  • Derivation of a tolerable intake or tolerable contact level that is considered to be without appreciable harm to health.

Chorley Consulting have extensive experience conducting TRAs based on E&L data from a wide range of analytical laboratories. We can use a variety of tools to ensure relevant estimates of patient exposure and identify appropriate reference values.

Where appropriate data cannot be identified, we have a number of in silico tools available to help in the evaluation of the toxicological risks associated with chemical structures including:

  • ToxTree – ToxTree is an in silico non-testing method for assessing the risks and hazards associated with a compound
  • If further evaluation of identified hazards posed by chemical is required, then a more detailed evaluation of the structures using software from Lhasa can be offered.
  • Derek Nexus is expert, knowledge-based toxicology software which gives predictions for a variety of endpoints including genotoxicty and sensitisation.
  • Sarah Nexus is a statistical software tool that gives accurate mutagenicity predictions

Developing the most practical path forward for your product

Biological safety is a continuous process throughout the lifecycle of a medical device.

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