Norm

ISO 7199:2016 en

Cardiovasculaire implantaten en kunstmatige organen - Bloedgaswisselaars (oxygeneratoren)

73,12

Over deze norm

Status Definitief
Aantal pagina's 13
Commissie Chirurgische implantaten
Gepubliceerd op 15-11-2016
Taal Engels
ISO 7199 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. This document also applies to heat exchangers and arterial filters that are integral parts of the oxygenator. This document also applies to external equipment unique to the use of the oxygenator. This document does not apply to - implanted oxygenators, - liquid oxygenators, - extracorporeal circuits (blood tubing), - separate heat exchangers, - separate ancillary devices, and - separate arterial line filter.

Details

ICS-code 11.040.40
Nederlandse titel Cardiovasculaire implantaten en kunstmatige organen - Bloedgaswisselaars (oxygeneratoren)
Engelse titel Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators)
Vervangt
Normatieve verwijzingen
  • 93/42/EEG, Medische hulpmiddelen

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