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ISO 10993-17 2023 Update: What You Need to Know

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The highly anticipated revision of ISO 10993-17:2002, titled “Biological Evaluation of Medical Devices — Part 17: Establishment of Allowable Limits for Leachable Substances,” has been released. The new version, ISO 10993-17:2023, now called “Biological Evaluation of Medical Devices — Part 17: Toxicological Risk Assessment of Medical Device Constituents,” not only brings a new title but also aligns with current best practices in toxicology and other ISO 10993 standards. Additionally, it introduces new tools that enable toxicologists to evaluate chemical constituents more consistently. The standard also presents new key concepts and provides detailed guidance on the methodology for conducting toxicological risk assessments.

Join leading toxicologists at NAMSA to explore the changes and their impact.

Attendees can expect to walk away with a better understanding of:

  • New concepts introduced by the revised standard and the principles and methodology used in toxicological risk assessment
  • Key similarities and differences between the old and new versions of the standard
  • Impact of the standard on biological evaluations based on the previous version and the necessary actions to address these changes


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