What are biomaterials?
Biomaterial and the device made from it are synthetic or of natural material. It can be used to produce, replace or treat living tissue without interfering with the functioning of the living tissue. Synthetic biomaterials include a wide variety of materials such as glass, gel, ceramics, polymers, or composites. Natural substances can be derived from human or animal bone, cartilage, connective tissue, and skin.
Regulations and provisions concerning biomaterials
The Medical Devices Regulation of the European Parliament and of the Council sets out general safety and performance requirements for biomaterials and products manufactured from them that are used in medical devices, with the exception of products of human or animal tissue origin. Provisions are set out for product requirements, clinical investigations, placing on the market and post-market follow-up.
Implant-installing units are required to keep lists of the implants they have installed. This information makes it possible to quickly trace the implants in hazard situations.
Requirements for the properties of biomaterials
High quality standards have been set for the design and manufacture of biomaterials. When materials are chosen, their mutual compatibility with body tissues and fluids must be ensured and the benefit-risk ratio of the product must be assessed. Specific requirements pertain to the chemical, physical and biological properties and sterility of materials and products. When materials of animal origin are used, it must be ensured that their handling process is of high standard of quality and that the origin of the material can be traced.
In addition to the essential requirements concerning biomaterials, European harmonised standards have been prepared. They include more detailed requirements and testing methods. The most important of these are the EN-ISO 10993 series of benefit-risk ratio standards, the EN-ISO 14155 clinical investigation standard, and the EN-ISO 14971 risk analysis standard.