STN EN ISO 7199
| Name: | STN EN ISO 7199 |
| Validity: | Valid |
| Number of pages: | 32 |
| Language: |
EN
|
| Paper: | 17,20€ |
| Electronic version |
a) Only read (without ability to print and copy)
15,48€ b) Without ability to print, with ability to copy (printscreen) 17,20€ c) With ability to print and copy (printscreen) 22,36€ |
| Slovak title | Kardiovaskulárne implantáty a umelé orgány. Výmenníky pre krv-plyn (oxygenátory) (ISO 7199: 2024) |
| English title | Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators) (ISO 7199:2024) |
| Release Date: | 01. 12. 2024 |
| Date of withdrawal: | |
| ICS: | 11.040.40 |
| Sorting character/National clasification code | 85 6250 |
| Level of incorporation: | idt EN ISO 7199:2024, idt ISO 7199:2024 |
| Official Journal | 11/24 |
| Amendments | |
| Replaced by: | |
| Repleces: | STN EN ISO 7199:2017-07 (85 6250) |
| Note in Official Journal: | |
| Subject of the standard: | 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 6 h, 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. This document also applies to heat exchangers and arterial filters that are integral parts of the oxygenator. This document also applies to external equipment unique to the use of the oxygenator. |
| Preview: | Náhľad normy (PDF) |