scope:

The standard pertains to biomaterials and their use in the production of medical devices (e.g. implants) for use in the living organism, in particular, in humans and animals. Biomaterials belonging to different classes of material and their composites are considered and described in detail in the individual sections.

The requirements arising from the concrete application are to be considered in the development of new biomaterials. Their use in medical devices or in medical devices in different fields is associated with variable potential risks. For example, the interactions both between the different materials and between the materials and the surrounding tissue are to be considered for biomaterials that are intended for use as combination of materials or composites belonging to different classes of material. Furthermore, additional requirements in relation to the potential for sterilisation are to be considered for biomaterials that are intended, for example, for use in sterile products. Biomaterials for an application that is in contact with solid tissue will be subject to different specific requirements relative to an application that is in contact with bodily fluids (blood, lymph, urine, cerebrospinal fluid, etc.).