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.

General information

  • Status :  Under development
  • Edition : 4
  • :
    ISO/TC 150/SC 2
    Cardiovascular implants and extracorporeal systems
  • 11.040.40
    Implants for surgery, prosthetics and orthotics

Got a question?

Check out our FAQs

Customer care
+41 22 749 08 88

Opening hours:
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.