This standard specifies a framework for the identification and, if necessary, quantification of the components of a medical device, using a general step-by-step approach to chemical characterization that allows for the identification of biohazards and the estimation and control of biological risks from material components.
It includes one or more of the following;
This standard can also be used for chemical characterization (eg identification or quantification) of degradation products. Information on other aspects of deterioration assessment is contained in ISO 10993-9, ISO 10993-13, ISO 10993-14 and ISO 10993-15.
This standard is intended for suppliers of materials and manufacturers of medical devices to support a biological assessment.
EUROLAB assists manufacturers with ISO 10993-18 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.
To get an appointment, to get more detailed information or to request an evaluation, you can ask us to fill in our form and reach you.