EN ISO 10993-19 Biological Evaluation of Medical Devices - Part 19: Physico-Chemical - Morphological and Topographic Characterization of Materials

EUROLAB, with its state-of-the-art accredited laboratories and expert team, provides precise and fast testing services within the scope of EN ISO 10993-19 testing. This standard provides a compilation of parameters and test methods that may be useful for the identification and evaluation of the physical, i.e., physico-chemical, morphological and topographic (PMT) properties of materials in finished medical devices. Such an assessment is limited by features related to biological assessment and intended use of the medical device (clinical application and duration of use), even if such features overlap with clinical efficacy.

This standard does not address the identification or quantification of decomposition products covered in EN ISO 10993‑9, EN ISO 10993‑13, EN ISO 10993‑14 and EN ISO 10993‑15, or the assessment of the physico-chemical properties of decomposed materials.

Chemical characterization of materials is covered by EN ISO 10993-18. The EN ISO 10993 series is not applicable when the material or device is not in direct or indirect contact with the body.

The compositional properties of the production materials are mainly under the control of the suppliers of these materials. However, other features are heavily influenced by the manufacturing processes used by the medical device manufacturer, as well as the requirements that the final medical device must meet.

EUROLAB assists manufacturers with EN ISO 10993-19 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.