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



September 28, 2023

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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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Phillip Smiraldo, PhD, DABT

Principal Toxicologist

Phillip holds a PhD in Molecular and Cellular Biology from the University of Toledo Medical Center (formerly Medical College of Ohio) and a BS in Biology from Bowling Green State University (summa cum laude; with minors in Chemistry and Italian Language). He was a Postdoctoral Fellow at the University of Texas Southwestern Medical Center (awarded two grants to support his research), authored several articles that were published in peer-reviewed journals (regarding his research of DNA repair in mammalian cells), and authored a book chapter appearing in Telomerases: Chemistry, Biology, and Clinical Applications, and has provided several oral presentations. Dr. Smiraldo’s timeless experience in the medical device industry encompasses toxicology, biological safety and preclinical study design, as well as extensive preparation of biological and toxicological risk assessments for submission in countries complying with EU and US FDA regulations. Prior to his current position as Toxicologist, he was a Medical Research Scientist and Study Director (NAMSA), overseeing special/custom preclinical functional studies, preclinical safety studies and simulated-use chemistry studies.  Before joining NAMSA, Dr. Smiraldo was a Staff Toxicologist at WIL Research (approximately 2.5 years), where he was a Study Director of preclinical safety studies for pharmaceutical- and chemical-based products.

Valériane Levelut

Senior Toxicologist

Valériane Levelut is a EUROTOX (ERT) certified Toxicological Pharmacist, with a rich experience as a safety assessor in many sectors. Before joining NAMSA she led the toxicological evaluation of medical devices, biocidal products, cosmetic products and food supplements at other organisations. Her role at NAMSA focuses on conducting biological evaluations and toxicological risk assessments in accordance with ISO 10993-1 and other medical device requirements, as well as assisting sponsors by addressing a wide range of issues related to biocompatibility and regulatory compliance.