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;
EUROLAB assists manufacturers with ISO 10993-17 test compliance. Our test experts, with their professional working mission and principles, provide you, our manufacturers and suppliers, the best service and controlled testing process in our laboratories. Thanks to these services, businesses receive more effective, high-performance and quality testing services and provide safe, fast and uninterrupted service to their customers.
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