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Toxicological Risk Assessment

ISO 10993-17: Standardizing Your Toxicological Risk Assessment (TRA)

Toxicological risk assessments are conducted to identify any potential risk to patients from the chemical constituents of the product.

It is important to note that finding “equivocal” results during the TRA is very common, especially in exhaustive extractions. These are findings for which toxicologists cannot deem the level of risk acceptable given the available information. Equivocal results often necessitate additional risk mitigation strategies to support safety. To learn more about mitigating risk in your medical device, Ask One Of Our Experts

Experience Matters

Our team of globally-recognized experts means you will be gaining insights from a team that is actively involved in the international standards committees,  including knowledge about upcoming standards changes and how different regulatory bodies are interpreting those standards.

Current experts:

  • Co-chair of the Biological Evaluation (AAMI/BE) Committee, the U.S. mirror committee for ISO 10993.
  • U.S. Delegate for TC 194, the technical committee for ISO 10993.
  • Previous President of the Medical Device and Combination Products Specialty Section of the Society of Toxicology.
  • U.S. and international delegate for ISO 10993 part 18 in chemical characterization, part 13 and the AAMI committee for TIR42.

 

Material characterizations completed

Risk assessments with complete chemical characterization