International Standard
ISO 7199:2016
Cardiovascular implants and artificial organs — Blood-gas exchangers (oxygenators)
Reference number
ISO 7199:2016
Edition 3
International Standard
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ISO 7199:2016
Published (Edition 3, 2016)
This standard has 1 amendment.

ISO 7199:2016

ISO 7199:2016
CHF 96
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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

  •  : Published
     : 2016-11
    : International Standard to be revised [90.92]
  •  : 3
     : 13
  • ISO/TC 150/SC 2
  • RSS updates


Amendments are issued when it is found that new material may need to be added to an existing standardization document. They may also include editorial or technical corrections to be applied to the existing document.

Amendment 1


Edition 2020

ISO 7199:2016/Amd 1:2020
CHF 18
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Sustainable Development Goals

This standard contributes to the following Sustainable Development Goal

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