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Normas DIN – AENOR
DIN EN ISO 14630:2005-08

DIN EN ISO 14630:2005-08

Non-active surgical implants - General requirements (ISO 14630:2005); German version EN ISO 14630:2005

Implants chirurgicaux non actifs - Exigences générales (ISO 14630:2005); Version allemande EN ISO 14630:2005

Nichtaktive chirurgische Implantate - Allgemeine Anforderungen (ISO 14630:2005); Deutsche Fassung EN ISO 14630:2005

Fecha Anulación:
2018-04 /Withdrawn
Equivalencias internacionales:

EN ISO 14630 (2005-05)

ISO 14630 (2005-05)

Relación con otras normas DIN:
Resumen:
This Standard specifies general requirements for non-active surgical implants. It is not applicable to dental implants, dental restorative materials, transendodontic and transradicular implants and intra-ocular lenses. With regard to safety, this document gives requirements for intended performance, design attributes, materials, design evaluation, manufacture, sterilization, packaging and information supplied by the manufacturer, and tests required to demonstrate compliance with these requirements. Additional tests are given or referred to in Level 2 and Level 3 Standards.
Keywords:
Bearings, 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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