ISO 10993-17:2023

Overview

ISO 10993-17:2023 - Biological evaluation of medical devices - Part 17: Toxicological risk assessment of medical device constituents - defines a standardized process for performing toxicological risk assessments of chemical constituents in medical devices. It specifies methods and criteria to determine whether exposure to a constituent is “without appreciable harm” and how that assessment integrates into the overall biological evaluation of a final product (per ISO 10993-1). The standard applies when chemical characterization data (e.g., extractables and leachables) are obtained in accordance with ISO 10993-18.

Key technical topics and requirements

• Scope and applicability: Focuses on constituents that contact the body and excludes non-contacting materials, device-drug APIs, biologic components, and exposures originating from non-device sources (food, water, air).
• Risk assessment framework: Outlines principles for hazard identification, risk estimation and risk acceptance within the biological evaluation process.
• Constituent-specific toxicology: Guidance on identifying hazardous constituents, selecting a point of departure (POD), and applying toxicological screening limits.
• Tolerable values and TTC: Procedures for deriving Tolerable Contact Level (TCL) and Tolerable Intake (TI) and for when to apply the Threshold of Toxicological Concern (TTC).
• Exposure dose estimation: Methods to calculate worst‑case estimated exposure doses from compositional, extractable or leachable data.
• Margin of Safety (MoS): How to compute MoS and combine MoS values to account for additivity or multiple endpoints.
• Decision criteria and reporting: Criteria for toxicological risk acceptance, when further testing or mitigation is required, and required reporting elements for regulatory submission.

Practical applications and users

ISO 10993-17:2023 is intended for toxicologists and other qualified professionals involved in medical device safety. Typical users and use cases:

• Medical device manufacturers assessing biocompatibility and safety of materials and finished devices.
• Regulatory affairs and quality teams preparing biological evaluation documentation for regulatory submissions.
• Contract testing laboratories conducting extractable/leachable studies and providing exposure estimates.
• Toxicologists and risk assessors deriving TCL/TI, PODs, TTC applications, and Margin of Safety calculations.
• Use cases include pre-market safety assessments, change-control evaluations for materials/processes, and post-market risk assessments.

Related standards

• ISO 10993-1 - Biological evaluation within a risk management process
• ISO 10993-18 - Chemical characterization of materials (extractables/leachables)
• ISO/TS 21726 - Reporting thresholds and related guidance
• ISO 14971 - Medical device risk management

Keywords: ISO 10993-17, toxicological risk assessment, medical devices, constituents, tolerable intake, tolerable contact level, exposure dose estimation, extractables and leachables, margin of safety, ISO 10993-18.