As part of a full product safety assessment following ISO 10993, manufacturers should perform a series of biocompatibility and analytical tests. Once testing is completed, the manufacturer needs to assess the data generated to determine the safety of the product for its intended use.
Toxicological risk assessments are part of the overall risk and safety assessment process that includes:
- Biological Evaluation Plan (BEP) – Initial review of the product, intended use, and justification or rationale for the selection of the test plan to determine or assess safety and toxicological risk.
- Extractables & Leachables Tests – Following guidance in ISO 10993, manufacturers complete testing using simulated extraction techniques and analytical methods to assess volatile, semivolatile, nonvolatile, and metals that leach or extract off of the device over time. This data can be used for toxicological safety assessments, and in some cases in lieu of in vivo or animal tests.
- Biocompatibility Tests – Following guidance in ISO 10993 and US FDA test matrices, manufacturers complete testing based on contact type (surface, subcutaneous, or implant), duration of contact or repeated exposure, and other factors. This may also include implant and functionality studies to assess how the device or product performs in living physiological model.
- Toxicological Assessment – Once this data is obtained, a trained expert should review the information and draw a conclusion regarding the safety and risk of the device to the target population. Generally this is performed or reviewed by a board certified toxicologist.
- ISO 10993