Use and application of biomaterials in the medical field are subject of this standard. In addition to the definition of biomaterials and associated terms in the context of materials sciences, biology, and medicine, the fields of application in the living organism are presented. This standard allows materials that are suitable for use in humans and animals to be narrowed down and the properties that define a biomaterial to be established. The standard defines the requirements of the qualification of materials as biomaterials that are oriented towards their concrete application and that can safeguard the determination of relevant properties, in particular, biocompatibility. The standard is addressed to scientists, developers, manufacturers and processors of biomaterials for medical devices as well as their users. It supports the fulfilment of regulatory requirements for marketing of medical devices.