ISO 7199:2016

Cardiovascular implants and artificial organs — Blood-gas exchangers (oxygenators)

Standard Details

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Status : WITHDRAWN

Standard Type: Main

Document No: ISO 7199:2016

Document Year: 2016

Pages: 13

Edition: 3

Section Volume:
ISO/TC 150/SC 2. Cardiovascular implants and extracorporeal systems

ICS:
11.040.40 Implants for surgery, prosthetics and orthotics

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