Biomaterials & Medical Devices
Biomaterial: A biocompatible material that is used to construct artificial organs, rehabilitation devices, or prostheses and replace natural body tissues or aids in their functions. Generally the term biomaterial describes the ability of a material to perform with an appropriate host response in a specific application.
(Ref: Williams Definition and ESB consensus)
Biomaterial Classifications
Biomedical materials can be divided roughly into three main types governed by the tissue response. In broad terms, inert (more strictly, nearly inert) materials illicit no or minimal tissue response. Active materials encourage bonding to surrounding tissue with, for example, new bone growth being stimulated. Degradable, or resorbable materials are incorporated into the surrounding tissue, or may even dissolve completely over a period of time. Metals are typically inert, ceramics may be inert, active or resorbable and polymers may be inert or resorbable.
Medical Device: Any instrument, apparatus, implement, machine, contrivance, in vitro reagent or combination of these that is intended for diagnosis, prevention or treatment of disease. [Ref: Medicines and Healthcare Products Regulatory Agency ( MHRA, UK), United States Federal Drug and Food Administration (FDA, USA)]
Orthopaedic Applications: Metallic, ceramic and polymeric biomaterials are used in orthopaedic applications.
Dental Applications: Metallic biomaterials have been used as pins for anchoring tooth implants and as parts of orthodontic devices. Ceramics have found uses as tooth implants including alumina and dental porcelains.
Medical Device may be classified as Class I, IIa, IIb and III with III covering the high risk product.
For further information please visit the official websites of the MHRA and the FDA via the links below:
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