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
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.
Legislation related to this standard
WITHDRAWN
EN 12022:1999
WITHDRAWN
EN ISO 7199:2014
99.60
Withdrawal effective
Jan 25, 2017
PUBLISHED
EN ISO 7199:2017