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prNS-EN ISO 7199:2023

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Note: This standard has a new edition: NS-EN ISO 7199:2024

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Abstract

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.

Document information

  • Standard from SN
  • Edition: 2023-07
  • Version: 1
  • Document type: NAT
  • ICS 11.040.40
  • National Committee CEN/TC 205

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