Standard

NS-EN ISO 21534:2007

Tilbaketrukket

Merknad: Denne standarden har en ny utgave: NS-EN ISO 21534:2009

Rettelser og tillegg kjøpes separat.

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Omfang

This International 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 International Standard, artificial ligaments and their associated fixing devices are included in the term "implant".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 conformance to this International 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

Referanser i lov

EU lov: 93/42/EEC

Produktrelasjon

Produkt livssyklus