DS/ISO 7199:2024
Current
Current
The latest, up-to-date edition.
Cardiovascular implants and artificial organs – Blood-gas exchangers (oxygenators)
Published date
16-09-2024
Publisher
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This document specifies requirements for sterile, single-use, extracorporeal blood-gas exchangers (oxygenators) intended for the supply of oxygen to, and the removal of carbon dioxide from, human blood, during cardiopulmonary bypass (CPB) for up to 6h, extracorporeal lung assist [ECLA with veno-venous (VV), veno-arterial (VA) or veno-arterial-venous (VAV) cannulation strategies], cardiopulmonary support (CPS), extracorporeal life support (ECLS with VA cannulation strategy), extracorporeal carbon dioxide removal (ECCO2R), and other extracorporeal circulation techniques requiring blood-gas exchange.
| Committee |
DS/S-160
|
| DocumentType |
Standard
|
| ProductNote |
This standard also refers toISO 10993-1,ISO 10993-11,ISO 11135,ISO 11137-1, ISO 11607-1, ISO 11607-2,ISO 17665,
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| PublisherName |
Danish Standards
|
| Status |
Current
|
| Standards | Relationship |
| ISO 7199:2024 | Identical |
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