Final Draft International Standard
ISO/FDIS 7199
Cardiovascular implants and artificial organs — Blood-gas exchangers (oxygenators)
Reference number
ISO/FDIS 7199
Edition 4
Final Draft
International Standard
ISO/FDIS 7199
83184
This draft is in the approval phase.
Will replace ISO 7199:2016

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.

General information

  •  : Under development
    : Proof sent to secretariat or FDIS ballot initiated: 8 weeks [50.20]
  •  : 4
     : 22
  • ISO/TC 150/SC 2
    11.040.40 
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