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Norm
ISO 14630:2008
Ausgabedatum: 2008 01 07
Non-active surgical implants — General requirements
ISO 14630:2008 specifies general requirements for non-active surgical implants. ISO 14630:2008 is not applicable to dental implants, dental restorative materials, transen...
Weiterlesen
ZURÜCKGEZOGEN
: 2012 11 28
Herausgeber:
International Organization for Standardization
Format:
Digital | 14 Seiten
Sprache:
Englisch
Aktuell Gültig:
ICS
ISO 14630:2008 specifies general requirements for non-active surgical implants. ISO 14630:2008 is not applicable to dental implants, dental restorative materials, transendodontic and transradicular implants, intra-ocular lenses and implants utilizing viable animal tissue.
With regard to safety, ISO 14630:2008 gives requirements for intended performance, design attributes, materials, design evaluation, manufacture, sterilization, packaging and information supplied by the manufacturer, and tests to demonstrate compliance with these requirements. Additional tests are given or referred to in level 2 and level 3 standards.