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NA 014

DIN Standards Committee Dentistry

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Standards [CURRENT]

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

Title (German)

Zahnheilkunde - Inhalt der Technischen Dokumentation für Dentalimplantatsysteme (ISO 10451:2010); Deutsche Fassung EN ISO 10451:2010

Overview

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.

Document: references other documents

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  

Edition 2010-11
Original language German
Translation English
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