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ISO 7199:2016
Cardiovascular implants and artificial organs — Blood-gas exchangers (oxygenators)More info
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.
| Author | ISO/TC 150/SC 2 Cardiovascular implants and extracorporeal systems |
|---|---|
| Editor | ISO |
| Document type | Standard |
| Format | Paper |
| Edition | 3 |
| ICS | 11.040.40 : Implants for surgery, prosthetics and orthotics |
| Number of pages | 13 |
| Replace | ISO 7199:2009 ISO 7199:2009/Amd 1:2012 |
| Modified by | ISO 7199:2016/DAmd 1 |
| Weight(kg.) | 0.1221 |
| Year | 2016 |
| Country | Switzerland |