ISO 10993-17 Biological Evaluation of Medical Devices - Test Standard for Determining Permissible Limits for Filtrate Substances

ISO 10993-17 specifies the determination of allowable limits for substances that can leach from medical devices. It is intended for use in deriving standards and estimating appropriate limits where standards are not available. It describes a systematic process by which identified risks from toxicologically hazardous substances contained in medical devices can be measured.

ISO 10993-17 cannot be applied to devices without patient contact.

Exposure to a particular chemical can result from sources other than the device, such as food, water, or air. ISO 10993-17 does not address the potential for exposure from such sources.

As outlined in ISO 10993-17, the risks associated with exposure to identified leaks are managed by quantifying the associated risks and limiting exposure to tolerable levels. The process of establishing these tolerable levels can be broken down into the following basic steps;

• Conduct extensive literature research; investigate critical health endpoint;
• Set a departure point (usually a NOAEL);
• Derive the Tolerable Intake (TI) specific to the route of entry and duration of exposure;
• Calculate Tolerable Exposure (TE) for target patient subgroups;
• Where appropriate, use, utility, etc. Change the first TE to;
• Compare the final TE with the estimated worst-case exposure of the potential leak and calculate a Margin of Safety (MOS).

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