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ILNAS-EN ISO 7199:2017 Edition 01/2017
Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators) (ISO 7199:2016)
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Abstract

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.

Status

Standard - Active

Origin

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

Implementation

start of the vote on the project    07/05/2015   date of ratification (dor)    06/11/2016
end of the vote on the project    07/08/2015   date of anouncement (doa)    30/04/2017
start of the vote on the final project    11/08/2016   date of publication (dop)    31/07/2017
end of the vote on the final project    05/10/2016   date of withdrawal (dow)    31/07/2017


Publication Official Journal
of the Grand-Duchy of Luxembourg
19/06/2017
Reference Mémorial A N° 573

Relations

Evolutions
ILNAS-EN ISO 7199:2017/A1:2020

Relations to older standards
ILNAS-EN ISO 7199:2014

Relations to international standards
ISO 7199 
ISO 7199 
ISO 7199 
ISO 7199:2016 

International Classification for Standards (ICS codes) :

11.040.40 : Implants for surgery, prosthetics and orthotics

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