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ILNAS-EN ISO 7199:2014 Edition 08/2014
Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators) (ISO 7199:2009 + Amd 1:2012)
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Abstract

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.

Status

Standard - Superseded

Origin

Technical Committee :
CEN/TC 205 : Non-active medical devices

Implementation

start of the vote on the project      date of ratification (dor)    17/07/2014
end of the vote on the project      date of anouncement (doa)    30/11/2014
start of the vote on the final project    16/01/2014   date of publication (dop)    28/02/2015
end of the vote on the final project    16/06/2014   date of withdrawal (dow)    28/02/2015


Publication Official Journal
of the Grand-Duchy of Luxembourg
07/11/2014
Reference

Relations

Evolutions
ILNAS-EN ISO 7199:2017

Relations to older standards
ILNAS-EN 12022:1999

International Classification for Standards (ICS codes) :

11.040.40 : Implants for surgery, prosthetics and orthotics

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