Fact Sheets

How to calculate the Analytical Evaluation Threshold for your Biocompatibility Assessment

Posted on by Congenius

The Analytical Evaluation Threshold (AET) is the crucial parameter for demonstrating that your analytical results sufficiently assess the biological safety of your medical device, and is subsequently the intersection between Toxicology, Biocompatibility and Analytical Testing.

To help explain the importance of the AET and the applicability of ISO/TS 21726:2019 to its calculation, our Operations team has compiled a useful, easy-to-read fact sheet. The resource includes:

  • An explanation of the importance of the AET including its connection with the threshold of toxicological concern (TTC) limits
  • How to calculate your AET, including the applicability of ISO/TS 21726:2019, ISO 10993-17, and ISO 10993-18
  • Tips & considerations for your next AET calculation

To access the fact sheet, press the Download button below.

Should you have a biocompatibility challenge, our MedTech experts are ready to help. Simply get in touch to start the conversation.

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