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Normas DIN – AENOR
DIN EN ISO 16061:2020-02

DIN EN ISO 16061:2020-02

Instruments for use in association with non-active surgical implants - General requirements (ISO/DIS 16061:2020); German and English version prEN ISO 16061:2020 / Note: Date of issue 2020-01-10*Intended as replacement for DIN EN ISO 16061 (2015-09).

Instruments à utiliser en association avec les implants chirurgicaux non actifs - Exigences générales (ISO/DIS 16061:2020); Version allemande et anglaise prEN ISO 16061:2020 / Attention: Date de parution 2020-01-10*Prévu pour remplacer DIN EN ISO 16061 (2015-09).

Instrumente, die in Verbindung mit nichtaktiven chirurgischen Implantaten verwendet werden - Allgemeine Anforderungen (ISO/DIS 16061:2020); Deutsche und Englische Fassung prEN ISO 16061:2020 / Achtung: Erscheinungsdatum 2020-01-10*Vorgesehen als Ersatz für DIN EN ISO 16061 (2015-09).

Fecha:
2020-02 /Active
Equivalencias internacionales:

ISO/DIS 16061 (2020-01)

prEN ISO 16061 (2020-01)

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:
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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