This standard contains requirements for the contents of technical files to demonstrate the fulfilment of regulatory requirements for a dental implant and any prefabricated part thereof that remains in the mouth after surgery. This standard is not applicable to instruments and other parts specifically made for a dental implant system but which do not remain in the mouth. However, documentation relating to these components may be included in the technical files. The International Standard has been prepared by ISO/TC 106/SC 8/WG 3 "Content of technical files" (secretariat: DIN), together with CEN/TC 55 "Dentistry" (secretariat: DIN). At DIN, the responsible Working Committee is NA 014-00-21 AA "Dentalimplantate" ("Dental implants") of NADENT.