International Standard
ISO 7199:2024
Cardiovascular implants and artificial organs — Blood-gas exchangers (oxygenators)
Reference number
ISO 7199:2024
Edition 4
2024-09
Preview
ISO 7199:2024
83184
No disponible en español
Publicado (Edición 4, 2024)

ISO 7199:2024

ISO 7199:2024
83184
Idioma
Formato
CHF 129
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Resumen

This document specifies requirements for sterile, single-use, extracorporeal blood-gas exchangers (oxygenators) intended for the supply of oxygen to, and the removal of carbon dioxide from, human blood, during cardiopulmonary bypass (CPB) for up to 6 h, extracorporeal lung assist [ECLA with veno-venous (VV), veno-arterial (VA) or veno-arterial-venous (VAV) cannulation strategies], cardiopulmonary support (CPS), extracorporeal life support (ECLS with VA cannulation strategy), extracorporeal carbon dioxide removal (ECCO2R), and other extracorporeal circulation techniques requiring blood-gas exchange.

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 filters.

Informaciones generales

  •  : Publicado
     : 2024-09
    : Norma Internacional publicada [60.60]
  •  : 4
     : 22
  • ISO/TC 150/SC 2
    11.040.40 
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