Abstract

This International Standard specifies requirements for the content of the technical documentation prepared to demonstrate compliance with the approval requirements for a dental implant and any associated prefabricated parts that remain in the mouth after the dental procedure. This International Standard does not apply to instruments and other parts that are specifically manufactured for a dental implant system but do not remain in the mouth. Nevertheless, the documentation for these components can be included in the technical documentation.

Begin

2022-08-26

WI

00055528

Planned document number

DIN EN ISO 10451

Project number

01402351

Responsible national committee

NA 014-00-21 AA - Dental implants  

Responsible european committee

CEN/TC 55 - Dentistry  

Responsible international committee

ISO/TC 106/SC 8/WG 3 - Content of technical files  

draft standard

Dentistry - Contents of technical file for dental implant systems (ISO/DIS 10451:2024); German and English version prEN ISO 10451:2024
2024-11
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previous edition(s)

Dentistry - Contents of technical file for dental implant systems (ISO 10451:2010); German version EN ISO 10451:2010
2010-11

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