Final Draft
International Standard
ISO/FDIS 13504
Dentistry — General requirements for instruments and related accessories used in dental implant placement and treatment
Reference number
ISO/FDIS 13504
Edition 2
© ISO 2026
Proyecto final Norma internacional
En desarrollo
Este borrador está en fase de aprobación.
Reemplazará ISO 13504:2012

Resumen

This document specifies general requirements for the manufacture of instruments and related accessories used in the placement of dental implants.

It is applicable to single-use and reusable instruments, regardless of whether they are manually driven or connected to a power-driven system.

This document does not apply to devices used for indirect contact with the human body, including 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.

Informaciones generales

  • Estado
     : En desarrollo
    Etapa
    : Texto final recibido o FDIS registrado para su aprobación formal [50.00]
  • Edición
     : 2
  • Comité Técnico :
    ISO/TC 106/SC 4
    ICS :
    11.060.25 
  • RSS actualizaciones

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Objetivos de Desarrollo Sostenible

Esta norma contribuye al siguiente Objetivo de Desarrollo Sostenible

3
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