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EN ISO 7199:2017

Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators) (ISO 7199:2016) EN ISO 7199:2017

Publication date:   Apr 18, 2017

General information

60.60 Standard published   Jan 25, 2017

CEN

CEN/TC 205 Non-active medical devices

European Norm

11.040.40   Implants for surgery, prosthetics and orthotics

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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.

Related legislation

Legislation related to this standard

93/42/EEC

Medical devices

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Life cycle

PREVIOUSLY

WITHDRAWN
EN ISO 7199:2014

NOW

PUBLISHED
EN ISO 7199:2017
60.60 Standard published
Jan 25, 2017

CORRIGENDA / AMENDMENTS

PUBLISHED
EN ISO 7199:2017/A1:2020

REVISED BY

IN_DEVELOPMENT
FprEN ISO 7199