Modern medical devices typically consist of many different components and parts made from innovative polymers, nanomaterials and other composite materials. These materials offer many significant advantages, such as smaller components and longer durability. But each material also has unique chemical and physical properties that can affect the health and safety of patients and users.

In the U.S., European Union (EU) and other major markets around the world, chemical characterization of materials is therefore an essential part of regulatory review and approval of medical devices. However, due to the complexity of the regulatory process, many manufacturers are unaware of the chemical characterization requirements or are unsure how to apply them to their products. This can lead to disruptions in the approval process and, as a result, delays in getting products to market.

The ISO 10993 series of standards addresses the biological evaluation of medical devices, including the potential application of the chemical characterization process. The series of standards comprises more than 20 individual standards, contains detailed information on aspects of biological evaluation, and serves as the basis for biocompatibility requirements for medical devices in most markets.

The range of biological hazards that can be posed by a medical device depends on various factors, such as the intended use of the device, the composition of the device material, and the health susceptibility of the individual patient. The standards in the DIN EN ISO 10993 series are therefore not prescriptive standards. Rather, they require that manufacturers of medicinal products implement a risk management system that identifies, thoroughly analyzes, and evaluates all potential biological risks to determine the likelihood and potential severity of the risk’s impact. Based on this information, manufacturers can then take the necessary steps to eliminate or mitigate the risk posed by their products.