BAS EN ISO 7199:2018
Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators)
General Information
Status: Published
No. of pages: 22
Language: English
Edition: 2.
Adoption method: Endorsment
Publication date: 29.08.2018
Technical committee:
...
Abstract
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.
Lifecycle
...
Original document and degree of correspondence
- EN ISO 7199:2017, identical
- ISO 7199:2016, identical