Reference number
ISO 7199:2016
ISO 7199:2016
Cardiovascular implants and artificial organs — Blood-gas exchangers (oxygenators)
Edition 3
2016-11
Retirada
ISO 7199:2016
67607
Retirada (Edición 3, 2016)

Resumen

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.

Informaciones generales

  •  : Retirada
     : 2016-11
    : Retirada de la Norma Internacional [95.99]
  •  : 3
     : 13
  • ISO/TC 150/SC 2
    11.040.40 
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