What’s New in ISO 10993-17:2023?

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In early September, the International Organization for Standardization (ISO) released new ISO standards for medical devices: the ISO 10993-17:2023 (en) Biological Evaluation of Medical Devices-Part 17—Toxicological Risk Assessment of Medical Device Constituents. This document specifies requirements for a toxicological risk evaluation process of medical device constituents that are used within the biological evaluation process. It includes methods and criteria for identifying if exposure to a component poses any significant toxicological risk. According to ISO 10993-1, the biological evaluation of the finished medical devices may include the toxicological risk assessment.

The procedure outlined in this publication is applicable to data on chemical characterization of medical devices acquired in accordance with ISO 10993-18. A toxicological risk assessment of either the compositional information or analytical chemistry data is needed to determine if the components’ toxicological hazards are minimal or acceptable.

The definition of hazards in ISO 10993-17:2023 emphasizes the elements that potentially cause harm relevant to exposure situations. A trio of criteria play a role in the new protocol’s risk estimation:

  1. Tolerable intake (TI) or contact level
  2. Worst-case estimated exposure dose (EEDmax)
  3. Margin of safety (MOS)

The recent updates to ISO 10993-17:2023 have brought about significant changes to the document. To start, the previous title, “Biological Evaluation of Medical Devices-Part 17: Establishment of Allowable Limits for Leachable Substances,” has been replaced with one that better reflects its scope and purpose. The terminology has also been overhauled to include several new terms, including:

  • Exposure dose
  • Carcinogen
  • Constituents
  • Dose-response
  • Harmful dose
  • Human carcinogen
  • Margin of safety

Other terms have been removed, including:

  • Allowable limit
  • Benefit factor
  • Concomitant exposure factor
  • Health benefit
  • Health hazard
  • Physiological based pharmacokinetic modeling

These terminology changes were implemented to bring more clarity and relevance of ISO 10993-17:2023 to medical device evaluation.

Additionally, the updated document offers more comprehensive guidance about:

  • When a toxicological risk assessment of a medical device is advised
  • How to calculate the worst-case estimated exposure dose of a constituent
  • When the likelihood of health harm should be addressed by other means

Based on the recently updated FDA guidance, Use of International Standard ISO 10993-1, “Biological evaluation of medical devices-Part 1: Evaluation and testing within a risk management process,” biocompatibility evaluations should be conducted within the framework of a risk management process. Once the risks have been identified, the sponsor should assess what information is already available regarding those risks and identify the knowledge gaps that remain in accordance with the additional biocompatibility standards. A plan should be developed to address the knowledge gaps either by biocompatibility testing or other evaluations that appropriately address the risks.

The guidance is intended for those who have some familiarity with medical devices, specifically toxicologists or other educated and skilled individuals who have the necessary education, work experience, and decision-making skills to apply it.

For more information about the updated standards, how to complete a hazard analysis on your medical device, or help getting FDA pre-market approval, contact us here. 

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