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: Under development
Edition: 4Number of pages: 14
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 Goals:
ISO 7199:2016/Amd 1:2020
ISO/DIS 7199Stage: 40.00
Got a question?
Check out our FAQs
Monday to Friday - 09:00-12:00, 14:00-17:00 (UTC+1)
Keep up to date with ISO
Sign up to our newsletter for the latest news, views and product information.