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Normas DIN – AENOR
DIN EN ISO 13504:2011-01

DIN EN ISO 13504:2011-01

Dentistry - General requirements for instruments and related accessories used in dental implant placement and treatment (ISO/DIS 13504:2011); German version prEN ISO 13504:2011 / Note: Date of issue 2011-01-31

Médecine bucco-dentaire - Exigences générales pour instruments dentaires et accessories utilisés en implantologie dentaire (ISO/DIS 13504:2011); Version allemande prEN ISO 13504:2011 / Attention: Date de parution 2011-01-31

Zahnheilkunde - Allgemeine Anforderungen an bei der Implantation verwendete Instrumente und Zubehör (ISO/DIS 13504:2011); Deutsche Fassung prEN ISO 13504:2011 / Achtung: Erscheinungsdatum 2011-01-31

Fecha Anulación:
2012-10 /Withdrawn
Equivalencias internacionales:

ISO/DIS 13504 (2011-01)

prEN ISO 13504 (2011-01)

Relación con otras normas DIN:

Reemplazada por: DIN EN ISO 13504:2012-10

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
72,24
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