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EN ISO 7199:2014

Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators) (ISO 7199:2009 + Amd 1:2012) EN ISO 7199:2014

Publication date:   Sep 19, 2014

General information

99.60 Withdrawal effective   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 7199:2009 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 7199:2009 also applies to heat exchangers that are integral parts of oxygenators and to external equipment unique to the use of the device.

Related legislation

Legislation related to this standard

93/42/EEC

Medical devices

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Life cycle

PREVIOUSLY

WITHDRAWN
EN 12022:1999

NOW

WITHDRAWN
EN ISO 7199:2014
99.60 Withdrawal effective
Jan 25, 2017

REVISED BY

PUBLISHED
EN ISO 7199:2017

Relations

Adopted from ISO 7199:2009 IDENTICAL

Adopted from ISO 7199:2009/Amd 1:2012 IDENTICAL