Abstract

This document specifies general requirements for the manufacture of instruments and related accessories used in the placement of dental implants and further manipulations of connecting parts in the craniofacial area. It is applicable to single-use and reusable instruments, regardless of whether they are manually driven or connected to a power-driven system. It is not applicable to the power-driven system itself, nor to the dental implant or to parts intended to be connected to the dental implant. With regard to safety, this document gives requirements for classification, intended performance, performance attributes, material selection, performance evaluation, manufacture, sterilization and information to be supplied by the manufacturer.

Begin

2023-12-21

WI

00055555

Planned document number

DIN EN ISO 13504

Project number

01402385

Responsible national committee

NA 014-00-04 AA - Rotary instruments  

Responsible european committee

CEN/TC 55 - Dentistry  

Responsible international committee

ISO/TC 106/SC 4/WG 13 - Implant instruments  

draft standard

Dentistry - General requirements for instruments and related accessories used in dental implant placement and treatment (ISO/DIS 13504:2024); German and English version prEN ISO 13504:2024
2024-07
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previous edition(s)

Dentistry - General requirements for instruments and related accessories used in dental implant placement and treatment (ISO 13504:2012); German version EN ISO 13504:2012
2012-10

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