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DIN EN ISO 13504:2025-06

Dentistry - General requirements for instruments and related accessories used in dental implant placement and treatment (ISO/DIS 13504.2:2025); German and English version prEN ISO 13504:2025 / Note: Date of issue 2025-05-02*Intended as replacement for DIN EN ISO 13504 (2012-10).

Fecha edición: 2025-06-01
En Vigor
Idiomas disponibles: Alemán, Inglés
Resumen: 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.

Keywords: Accessories|Approval|Compatibility|Definitions|Dental equipment|Dental implants|Dental instruments|Dentistry|Design|Disposables|Efficiency|Equipment for single use|Face (anatomy)|Head (anatomy)|Implants (surgical)|Instructions for use|Joining elements|Labelling|Manufacturing|Marking|Materials|Medical devices|Packages|Performance|Production|Properties|Reprocessing|Re-usable|Safety|Specification (approval)|Sterilization (hygiene)|Surgical instruments|Testing
ICS: 11.060.25 - Instrumentos dentales, 11.040.30 - Instrumentos y materiales quirúrgicos
CTN:

Reemplazo Normas

Reemplaza a DIN EN ISO 13504:2024-07

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