prEN ISO 7199

Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators) (ISO/DIS 7199:2023) prEN ISO 7199

Publication date:   Jul 20, 2023

General information

45.99 Dispatch of FV draft to CCMC   Mar 6, 2024

CEN

CEN/TC 205 Non-active medical devices

European Norm

11.040.40   Implants for surgery, prosthetics and orthotics

Buying

Draft

Language in which you want to receive the document.

Scope

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.

Life cycle

PREVIOUSLY

PUBLISHED
EN ISO 7199:2017

PUBLISHED
EN ISO 7199:2017/A1:2020

NOW

IN_DEVELOPMENT
prEN ISO 7199
45.99 Dispatch of FV draft to CCMC
Mar 6, 2024