This International Standard specifies requirements for the contents of a technical file to demonstrate the
fulfilment of regulatory requirements for a dental implant and any prefabricated part thereof that remains in the
mouth after surgery.
This International Standard is not applicable to instruments and other parts specifically made for the dental
implant system but which do not remain in the mouth. However, documentation relating to these components
may be included in the technical file.
BS EN ISO 10451:2010 history
2010BS EN ISO 10451:2010 Dentistry - Contents of technical file for dental implant systems