<p>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.</p>
<p>ISO 7199:2016 also applies to heat exchangers and arterial filters that are integral parts of the oxygenator.</p>
<p>ISO 7199:2016 also applies to external equipment unique to the use of the oxygenator.</p>
<p>ISO 7199:2016 does not apply to</p>
<p>- implanted oxygenators,</p>
<p>- liquid oxygenators,</p>
<p>- extracorporeal circuits (blood tubing),</p>
<p>- separate heat exchangers,</p>
<p>- separate ancillary devices, and</p>
<p>- separate arterial line filter.</p>
Registration number (WIID)
67607
Scope
<p>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.</p>
<p>ISO 7199:2016 also applies to heat exchangers and arterial filters that are integral parts of the oxygenator.</p>
<p>ISO 7199:2016 also applies to external equipment unique to the use of the oxygenator.</p>
<p>ISO 7199:2016 does not apply to</p>
<p>- implanted oxygenators,</p>
<p>- liquid oxygenators,</p>
<p>- extracorporeal circuits (blood tubing),</p>
<p>- separate heat exchangers,</p>
<p>- separate ancillary devices, and</p>
<p>- separate arterial line filter.</p>
