DIN EN ISO 7199:2024-12
Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators) (ISO 7199:2024); German version EN ISO 7199:2024
| Fecha de anulación: |
2025-12-01
Anulada
|
|---|---|
| Idiomas disponibles: | Inglés |
| Resumen: | 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. |
| Keywords: | Artificial organs|Blood|Blood-gas exchangers (oxygenators)|Cardiology|Connections|Connectors|Definitions|In vitro|Marking|Medical products|Medical technology|Oxygenators|Packages|Physical properties|Properties|Surgical implants|Testing|Vascular system |
| ICS: | 11.040.40 - Implantes quirúrgicos, prótesis y ortesis |
| CTN: | |
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Equivalencia Internacional |
Idéntica EN ISO 7199:2024 Idéntica ISO 7199:2024 |
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Reemplazo Normas |
Reemplaza a DIN EN ISO 7199:2020-10 Reemplaza a DIN EN ISO 7199:2023-08 Es reemplazada por DIN EN ISO 7199:2025-12 |
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