ISO 10993-17:2023

ISO 10993-17:2023 provides the framework for establishing allowable limits for leachable substances from medical devices using a toxicological risk assessment approach. It specifies the methods for calculating tolerable exposure limits and margins of safety for chemical substances that may be released from medical devices during clinical use.

Overview

Background

Published by the International Organization for Standardization (ISO) as part of the ISO 10993 series, this standard was updated in 2023 to reflect advances in toxicological science and risk assessment methodologies. It provides a systematic approach to chemical risk assessment that supports the biological evaluation framework established in ISO 10993-1.

Applicability

This standard applies to manufacturers of medical devices where chemical substances may leach from the device into the patient or user during intended use. It is particularly relevant for devices with prolonged or permanent body contact, implantable devices, and devices that come into contact with blood or internal tissues. It works in conjunction with ISO 10993-18 for chemical characterization.

Core Principles

Tolerable exposure limit calculation

Margin of safety determination

Toxicological data evaluation

Route of exposure considerations

Duration and frequency of exposure assessment

Cumulative risk assessment for multiple substances

Uncertainty factor application

Toxicological risk characterization