Standard

NS-EN ISO 16672:2015

Tilbaketrukket

Merknad: Denne standarden har en ny utgave: NS-EN ISO 16672:2021

Rettelser og tillegg kjøpes separat.

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Omfang

ISO 16672:2015 applies to ocular endotamponades (OE), a group of non-solid implants used in ophthalmology to flatten and position a detached retina onto the choroid, or to tamponade the retina. With regard to the safety and efficacy of OE, this International Standard specifies requirements for their intended performance, design attributes, pre-clinical and clinical evaluation, sterilization, product packaging, product labelling and the information supplied by the manufacturer.

Dokumentinformasjon

  • Standard fra SN
  • Publisert:
  • Tilbaketrukket:
  • Utgave: 2015-08
  • Versjon: 1
  • Varetype: NAT
  • ICS 11.040.70
  • National Committee CEN/TC 170

Referanser i lov

EU lov: 93/42/EEC

Produktrelasjon

Produkt livssyklus