CAN/CSA-ISO 7199-00:2000 Edition
$11.70
Cardiovascular Implants and Artificial Organs – Blood-Gas Exchangers (Oxygenators)
| Published By | Publication Date | Number of Pages |
| CSA | 2000-04-01 | 19 |
Scope
This International Standard specifies requirements for sterile, single-use, extracorporeal blood-gas exchangers (oxygenators) in tended for supply of oxygen to, and removal of carbon dioxide from, the blood of humans.
This International Standard also applies to heat exchangers that are integral parts of oxygenators and to external equipment unique to the use of the device.
This International Standard does not apply to:
- implanted oxygenators;
- liquid oxygenators;
- extracorporeal circuits (blood tubing);
- separate heat exchangers;
- separate ancillary devices.
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