Standard

NS-EN 12010:1998

Tilbaketrukket

Rettelser og tillegg kjøpes separat.

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Omfang

This European Standard specifies particular requirements for total and partial joint replacement implants, artificial ligaments and bone cement, hereafter referred to as implants. For the purposes of this standard, artificial ligaments and their associated fixing devices are included in the term implant, hereinafter referred to as implants. It specifies requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging and information to be supplied by the manufacturer. Some tests required to demonstrate compliance with this standard are contained in or referenced in level 3 standards.

Dokumentinformasjon

  • Standard fra SN
  • Publisert:
  • Tilbaketrukket:
  • Utgave: 1
  • Versjon: 1
  • Varetype: NAT
  • ICS 11.040.40
  • National Committee CEN/TC 285/WG 4

Referanser i lov

EU lov: 93/42/EEC

Produktrelasjon

Produkt livssyklus