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Norm
ISO 14630:2005
Ausgabedatum: 2005 05 04
Non-active surgical implants — General requirements
ISO 14630:2005 specifies general requirements for non-active surgical implants, hereafter referred to as implants. It is not applicable to dental implants, dental restora...
ZURÜCKGEZOGEN: 2008 01 07
Herausgeber:
International Organization for Standardization
Format:
Digital | 13 Seiten
Sprache:
Englisch
Aktuell Gültig:
ICS
ISO 14630:2005 specifies general requirements for non-active surgical implants, hereafter referred to as implants. It is not applicable to dental implants, dental restorative materials, transendodontic and transradicular implants and intra-ocular lenses.
With regard to safety, ISO 14630:2005 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.
