ISO 10993-18 Biological Evaluation of Medical Devices - Test Standard for Chemical Characterization of Medical Device Materials within a Risk Management Process

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;

• Identification of construction materials (medical device configuration);
• Characterization of building materials by identifying and quantifying their chemical components (material composition);
• Characterization of the medical device for chemicals produced during manufacture (eg mold release agents, process contaminants, sterilization residues);
• Estimation of the chemical release potential (using laboratory extraction conditions) of medical device or construction materials under conditions of clinical use (they can be extracted);
• Measurement of chemicals released from a medical device under clinical use conditions (they can be filtered).

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.