ISO/FDIS 13504
Dentistry — General requirements for instruments and related accessories used in dental implant placement and treatment
| Fecha edición: |
2026-03-05
En Vigor
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| 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. L'ISO 13504:2012 spécifie les exigences générales pour la fabrication d'instruments et accessoires connexes pour la pose des implants dentaires et pour les manipulations ultérieures des éléments de raccordement dans la région cranio-faciale. L'ISO 13504:2012 s'applique aux instruments à usage unique et aux instruments réutilisables, qu'ils soient à commande manuelle ou raccordés à des systèmes commandés par moteur. |
| ICS: | 11.060.25 - Instrumentos dentales |
| CTN: | ISO/TC 106/SC 4 - 51296 |
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Anulaciones Normas |
Anula a ISO 13504:2012 |
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Equivalencia Internacional |
Idéntica PNE-prEN ISO 13504 |
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Normas Conjuntas |
Trabajo conjunto ISO/TS 20432:2022 |










