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.
Status: PublishedPublication date: 2016-11
Edition: 3Number of pages: 13
Technical Committee: ISO/TC 150/SC 2 Cardiovascular implants and extracorporeal systems
- ICS :
- 11.040.40 Implants for surgery, prosthetics and orthotics
This standard contributes to the following Sustainable Development Goal:
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ISO 7199:2009/Amd 1:2012
A standard is reviewed every 5 years
Stage: 90.92 (To be revised)
Corrigenda / AmendmentsPublished
ISO 7199:2016/Amd 1:2020
Will be replaced byUnder development
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