White Paper: Toxicological Risk Assessment of Medical Devices

How ISO 10993-17:2023 Shifts Focus to Risk Assessment

This white paper discusses the significant updates to ISO 10993-17, a standard crucial for the toxicological risk assessment (TRA) of medical devices. Historically, there has been a lack of published guidance on conducting TRAs for medical devices, leading to inconsistent approaches among toxicologists. The revised ISO 10993-17 aims to address this gap by providing a more standardized approach.

Key Changes and Updates:

1. Name Change: The standard’s title has been updated from “Methods for the establishment of allowable limits for leachable substances” to “Toxicological risk assessment of medical device constituents.” This change reflects the intent to estimate toxicological risk based on tolerable intake (TI) or tolerable contact level (TCL) and worst-case estimated exposure dose (EEDmax).
2. Systematic Approach: The revised standard introduces a systematic approach to TRAs, including hazard identification, risk estimation, establishment of TI or threshold of toxicological concern (TTC), calculation of EEDmax, and margin of safety (MOS).
3. Toxicological Screening Limit (TSL): The concept of TSL is introduced, which is a cumulative exposure dose over a specified time that is without appreciable harm to health. The TSL helps determine whether the total quantity of an identified chemical constituent is too low to elicit toxicity.
4. Risk Estimation: The toxicological risk is estimated when exposure to a constituent exceeds a predetermined level that results in relevant harm under anticipated conditions of medical device use. The risk is tolerable when the total quantity of a constituent is at or below the TSL or the worst-case estimated exposure dose is below the applicable TTC or TI.
5. Outdated Terms: Several terms are now considered outdated, including “allowable limit,” “benefit factor,” “proportional exposure factor,” “tolerable exposure,” and “utilization factor.”

Navigating toxicological risk just got clearer. Download our white paper to explore how the updated ISO 10993-17:2023 standard brings structure and consistency to medical device risk assessments.