VDI 5701:2016-09

Use and application of biomaterials in the medical field are subject of this standard. Additionally to the definition of biomaterials and adjacent terms in the fields of material sciences, biology, and medicine, the scopes of application are presented on the living organism. The standard delimits materials for the application on humans and animals, and elaborates determining properties of a biomaterial. In the standard, requirements for the qualification of materials as biomaterials are determined which are based on the actual use and are able to ensure the detection of relevant properties, particularly 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.