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Normas DIN – AENOR
DIN EN ISO 16061:2015-09

DIN EN ISO 16061:2015-09

Instrumentation for use in association with non-active surgical implants - General requirements (ISO 16061:2015); German version EN ISO 16061:2015 / Note: To be replaced by DIN EN ISO 16061 (2020-02).

Instrumentation à utiliser en association avec les implants chirurgicaux non actifs - Exigences générales (ISO 16061:2015); Version allemande EN ISO 16061:2015 / Attention: À remplacer par DIN EN ISO 16061 (2020-02).

Instrumente, die in Verbindung mit nichtaktiven chirurgischen Implantaten verwendet werden - Allgemeine Anforderungen (ISO 16061:2015); Deutsche Fassung EN ISO 16061:2015 / Achtung: Vorgesehener Ersatz durch DIN EN ISO 16061 (2020-02).

Fecha:
2015-09 /Active
Equivalencias internacionales:

EN ISO 16061 (2015-05)

ISO 16061 (2015-05)

Relación con otras normas DIN:
Resumen:
This International Standard specifies general requirements for instruments to be used in association with non-active surgical implants. These requirements apply to instruments when they are manufactured and when they are resupplied after refurbishment. This International Standard also applies 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, materials, design evaluation, manufacture, sterilization, packaging and information supplied by the manufacturer. This International Standard is not applicable to instruments associated with dental implants, transendodontic and transradicular implants and ophthalmic implants.
Keywords:
Bearings, Biological hazards, Checks, Clinical, Composition, Connections, Construction details, Damage, Definitions, Design, Evaluations, General conditions, Implants (surgical), Inactive, Instructions for use, Instruments, Marking, Materials, Measurement, Measuring techniques, Medical devices, Medical equipment, Medical products, Medical sciences, Packages, Production, Protection, Selection, Specification (approval), Sterile, Sterilization (hygiene), Storage, Surgery, Surgical equipment, Surgical implants, Surgical instruments, Testing, Transport
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