Standard

NS-EN 12011:1998

Tilbaketrukket
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Omfang

This European Standard specifies general requirements for instruments to be used in association with non-active surgical implants. These requirements apply to instruments when they are manufactured and when they are resupplied after refurbishment. This standard applies to instruments which may be connected to powered driven systems, but does not apply to the powered driven system itself. This standard is not applicable to instruments associated with dental implants, transendodontic and transradicular implants and ophthalmic implants. 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.

Dokumentinformasjon

  • Standard fra SN
  • Publisert:
  • Tilbaketrukket:
  • Utgave: 1
  • Versjon: 1
  • Varetype: NAT
  • ICS 11.040.30
  • National Committee CEN/TC 285

Referanser i lov

EU lov: 93/42/EEC

Produktrelasjon

Produkt livssyklus