EN ISO 10993-22 Biological Evaluation of Medical Devices - Part 22: Standard Test for Nanomaterials Guidance

EUROLAB, with its state-of-the-art accredited laboratories and expert team, provides precise and fast testing services within the scope of EN ISO 10993-22 testing. EN ISO 10993-22 describes aspects related to the biological evaluation of medical devices consisting of or containing nanomaterials. In addition, this guideline can also be used for the evaluation of nano-objects resulting from degradation, wear products or mechanical treatment processes (e.g. in situ grinding, polishing of medical devices) of manufactured medical devices (components).

EN ISO 10993-22 includes considerations regarding:

• Characterization of nanomaterials;
• Sample preparation for testing nanomaterials;
• Release of nano-objects from medical devices;
• Toxicokinetics of nanoobjects;
• Biological evaluation of nanomaterials;
• Presentation of results;
• Risk assessment of nanomaterials in the context of medical device assessment;
• Biological evaluation report;
• Nanostructures intentionally produced on the surface of a medical device during the engineering, manufacture or processing of a medical device.

EN ISO 10993-22 aims to provide a general framework and highlights important considerations when evaluating the safety of medical devices consisting of, containing or producing nanoobjects. In addition, the standard identifies several common pitfalls and barriers identified when testing nanomaterials compared to bulk materials or small molecule chemical species. As a technical report, this standard represents current technical knowledge on nanomaterials. No detailed test protocols are outlined or provided. This standard can form the basis for future documents with detailed protocols focusing on nanomaterials testing.

EUROLAB assists manufacturers with EN ISO 10993-22 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.