Overview
ISO 10993-17:2023/Amd 1:2025 is the latest amendment to the international standard focused on the biological evaluation of medical devices, specifically addressing toxicological risk assessment of medical device constituents. This document, developed by ISO Technical Committee ISO/TC 194 in collaboration with CEN/TC 206, updates the guidance on assessing the toxicological risks posed by chemical constituents within medical devices. It ensures that manufacturers and regulatory bodies have clear, scientifically robust criteria to evaluate potential toxicological hazards associated with device materials.
This amendment refines definitions, formulas, screening limits, and examples for cumulative exposure assessments and toxicological screening limits (TSLs), enhancing the accuracy of risk evaluations. The update reflects advances in chemical characterization techniques and risk management processes that align with related ISO 10993 standards.
Key Topics
- Toxicological Screening Limits (TSL): Revision of calculations for TSL based on mutagenic Threshold of Toxicological Concern (TTC) values adjusted to exposure duration.
- Cumulative Exposure Dose (TQₘₐₓ): Introduction and clarification of concepts related to cumulative exposure doses for device constituents over the contact period with the body.
- Formula Adjustments: Modifications to mathematical formulas used to estimate screening limits and exposure doses, including parameters such as duration of exposure and surface area factors.
- Exclusions: Specification of constituents and situations where toxicological screening limits do not apply, particularly for devices used in preterm or very young infants or for prolonged durations.
- Chemical Characterization Integration: Enhanced cross-reference and usage of ISO 10993-18:2020 (and its amendments) for chemical characterization of medical device materials in risk assessment workflows.
- Risk Assessment Process Flow: Updates to decision trees and flowcharts ensuring clarity in how toxicological data should be assessed and applied in biological evaluation.
- Terminology and Notes: Editorial updates to ensure consistent interpretation of critical terms such as maximum total quantity (TQₘₐₓ) and estimated exposure doses.
Applications
ISO 10993-17:2023/Amd 1:2025 is essential for:
- Medical Device Manufacturers: Establishing and refining internal toxicological risk assessment processes for new and existing devices to meet regulatory requirements.
- Regulatory Compliance: Supporting conformity with global safety standards by providing recognized methodologies for evaluating chemical risks from device constituents.
- Safety and Biocompatibility Testing: Guiding preclinical material evaluation teams to assess chemical risks using up-to-date TTC-based limits and exposure assumptions.
- Material Selection and Design: Assisting engineers and material scientists in choosing safer constituents or materials with minimized toxicological concerns.
- Clinical Evaluations and Assessments: Informing clinical safety reviews, especially regarding long-term exposure in vulnerable patient populations such as neonates.
Related Standards
- ISO 10993-1: Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process.
- ISO 10993-18:2020 (and Amendment 1:2022): Chemical characterization of medical device materials within a risk management process, referenced heavily in Amendment 1.
- ISO/IEC Directives Parts 1 & 2: Guidelines for the drafting, approval, and maintenance of ISO standards.
- ISO 10993 Series: Comprehensive suite of standards covering biological and clinical evaluation across multiple parts relevant to medical device safety.
Summary
ISO 10993-17:2023/Amd 1:2025 reinforces reliable and consistent methods for toxicological risk assessment of medical device constituents. By updating key parameters, formulas, and scope exclusions, this amendment directly contributes to enhanced patient safety, improved regulatory adherence, and supports manufacturers in managing the intrinsic risks posed by device materials. Implementing this standard helps streamline risk management workflows and ensures up-to-date alignment with the evolving scientific understanding in medical device biocompatibility assessment.
For detailed guidance and official documentation, consult the full standard available through the ISO website.
Open preview (PDF)Biological evaluation of medical devices — Part 17: Toxicological risk assessment of medical device constituents — Amendment 1
