UNE-EN ISO 7199:2017
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators) (ISO 7199:2016) (Endorsed by Asociación Española de Normalización in April of 2017.)
01-04-2017
16-03-2017
This International Standard 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.
This International Standard also applies to heat exchangers and arterials filters that are integral parts of the oxygenator.
This International Standard also applies to external equipment unique to the use of the device.
This International Standard does not apply to:
implanted oxygenators;
liquid oxygenators;
extracorporeal circuits (blood tubing);
separate heat exchangers;
separate ancillary devices
separate arterial line filter.
| Committee |
CTN 111
|
| DevelopmentNote |
NEW CHILD IS ADDED AMD 1 2020
|
| DocumentType |
Standard
|
| ProductNote |
NEW CHILD IS ADDED AMD 1 2020
|
| PublisherName |
Asociación Española de Normalización
|
| Status |
Superseded
|
| SupersededBy |
| Standards | Relationship |
| EN ISO 7199:2017 | Identical |
| ISO 7199:2016 | Identical |
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