Standard

NS-EN ISO 7199:2017

Tilbaketrukket

Merknad: Denne standarden har en ny utgave: NS-EN ISO 7199:2024

Forhåndsvisning

Rettelser og tillegg kjøpes separat.

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Omfang

ISO 7199:2016 specifies requirements for sterile, single-use, extracorporeal blood-gas exchangers (oxygenators) intended for supply of oxygen to, and removal of carbon dioxide from, the blood of humans.ISO 7199:2016 also applies to heat exchangers and arterial filters that are integral parts of the oxygenator.ISO 7199:2016 also applies to external equipment unique to the use of the oxygenator.ISO 7199:2016 does not apply to- implanted oxygenators,- liquid oxygenators,- extracorporeal circuits (blood tubing),- separate heat exchangers,- separate ancillary devices, and- separate arterial line filter.

Dokumentinformasjon

  • Standard fra SN
  • Publisert:
  • Tilbaketrukket:
  • Utgave: 2017-01
  • Versjon: 1
  • Varetype: NAT
  • ICS 11.040.40
  • National Committee CEN/TC 205

Referanser i lov

EU lov: 93/42/EEC

Produktrelasjon

Produkt livssyklus