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DIN EN ISO 13504:2012-10

Dentistry - General requirements for instruments and related accessories used in dental implant placement and treatment (ISO 13504:2012); German version EN ISO 13504:2012 / Note: To be replaced by DIN EN ISO 13504 (2024-07), DIN EN ISO 13504 (2025-06).

Fecha edición: 2012-10-01
En Vigor
Idiomas disponibles: Inglés, Alemán
Resumen: This Standard specifies general requirements for instruments and related accessories to be used specifically in dental implantology in the craniofacial area. These requirements apply to instruments when they are manufactured. This includes instruments for single-use and reusable instruments.This International Standard applies to instruments used on the patient which are manually driven instruments and to instruments which may be connected to power-driven systems, but does not apply to the power-driven systems themselves.With regard to safety this International Standard gives requirements for intended performance, design attributes, selection of materials, design evaluation, manufacture, sterilization, packaging and information to be supplied by the manufacturer.

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

Equivalencia Internacional

Idéntica EN ISO 13504:2012

Idéntica ISO 13504:2012

Reemplazo Normas

Reemplaza a DIN EN ISO 13504:2011-01

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