BS EN ISO 10451:2010 PDF

1   Scope 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 .