Standard

NS-EN ISO 14630:2012

Tilbaketrukket

Merknad: Denne standarden har en ny utgave: NS-EN ISO 14630:2024

Rettelser og tillegg kjøpes separat.

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Omfang

ISO 14630:2012 specifies general requirements for non-active surgical implants. ISO 14630:2012 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 14630:2012 specifies 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.

Dokumentinformasjon

  • Standard fra SN
  • Publisert:
  • Tilbaketrukket:
  • Utgave: 2012-12
  • Versjon: 1
  • Varetype: NAT
  • ICS 11.040.40
  • National Committee CEN/TC 285

Referanser i lov

EU lov: 93/42/EEC, 2007/47/EC

Produktrelasjon

Produkt livssyklus