The document specifies general requirements for non-active surgical implants. The document is not applicable to dental implants, dental restorative materials, transendodontic and transradicular implants and intraocular lenses. With regard to safety, it gives requirements for intended performance, design attributes, materials, design 3 evaluation, manufacture, sterilization, packaging and informations supplied by the manufacturer, and tests. Tests required to be used to demonstrate compliance with the document are contained in other levels.