Standard

NS-EN ISO 21534:2009

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Omfang

ISO 21534:2007 specifies particular requirements for total and partial joint replacement implants, artificial ligaments and bone cement, referred to as implants in the text. For the purposes of this International Standard, artificial ligaments and their associated fixing devices are included in the term "implant".ISO 21534:2007 specifies requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging and information to be supplied by the manufacturer.

Dokumentinformasjon

  • Standard fra SN
  • Publisert:
  • Utgave: 2009-05
  • Versjon: 1
  • Varetype: NAT
  • ICS 11.040.40
  • Nasjonal komité CEN/TC 285

Referanser i lov

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

Produktrelasjon

Produkt livssyklus