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EVS-EN ISO 7199:2017

Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators) (ISO 7199:2016)

General information

Withdrawn from 01.10.2024
Base Documents
ISO 7199:2016; EN ISO 7199:2017
Directives or regulations
None

Standard history

Status
Date
Type
Name
01.10.2024
Main
15.04.2020
Amendment
03.02.2017
Main
03.09.2014
Main
EVS-EN ISO 7199:2014
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.

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