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 which 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.
ISO 10451:2002 history
2010ISO 10451:2010 Dentistry - Contents of technical file for dental implant systems
2002ISO 10451:2002 Dental implant system - Contents of technical file