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Normas DIN – AENOR
DIN EN ISO 14630:2004-04

DIN EN ISO 14630:2004-04

Non-active surgical implants - General requirements (ISO/DIS 14630:2003); German version prEN ISO 14630:2003

Implants chirurgicaux non actifs - Exigences générales (ISO/DIS 14630:2003); Version allemande prEN ISO 14630:2003

Nichtaktive chirurgische Implantate - Allgemeine Anforderungen (ISO/DIS 14630:2003); Deutsche Fassung prEN ISO 14630:2003

Fecha Anulación:
2015-08 /Withdrawn
Equivalencias internacionales:

ISO/DIS 14630 (2003-12)

prEN ISO 14630 (2003-12)

Relación con otras normas DIN:

Reemplazada por: DIN EN ISO 14630:2005-08

Resumen:
This European Standard specifies general requirements for non-active surgical implants. This standard is not applicable to dental implants, dental restorative materials, transendodontic and transradicular implants and intra-ocular lenses. With regard to safety, this standard gives requirements for intended performance, design attributes, materials, design evaluation, manufacture, sterilization, packaging and information supplied by the manufacturer, and tests. Tests required to be used to demonstrate compliance with this standard are contained in other levels.
Diese Europäische Norm legt allgemeine Anforderungen für nichtaktive chirurgische Implantate fest. In bezug auf die Sicherheit legt diese Norm Anforderungen für die beabsichtigte Funktion, Kontruktionsmerkmale, Werkstoffe, Designprüfung, Herstellung, Sterilisation, Verpackung und die Bereitstellung von Informationen durch den Hersteller sowie Prüfverfahren fest.
Keywords:
Bearings, Biological hazards, Checks, Clinical, Damage, Data of the manufacturer, Definitions, Design, Evaluations, Fine mechanics, Implants (surgical), Inactive, Information, Marking, Materials, Medical devices, Medical equipment, Medical instruments, Medical products, Medical sciences, Non-active, Packages, Performance, Production, Protection, Residues, Specification (approval), Sterile, Sterility, Sterilization (hygiene), Surgery, Surgical, Surgical implants, Testing, Transport
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