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DIN EN ISO 25539-1:2009-01
Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses (ISO 25539-1:2003 + Amd 1:2005); German version EN ISO 25539-1:2008 / Note: A transition period, as set out in DIN EN ISO 25539-1 (2009-08), exists until 2010-03-21.
| Fecha edición: |
2009-08-01
Anulada
|
|---|---|
| Fecha cancelación: | 2009-08-01 |
| Idiomas disponibles: | Inglés, Alemán |
| Resumen: | Part 1 of ISO 25539 specifies requirements for endovascular prostheses, based upon current medical knowledge. With regard to safety, it gives requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization packaging and information supplied by the manufacturer. It should be considered as a supplement to ISO 14630. This International Standard is applicable to endovascular prostheses used to treat arterial aneurysms, arterial stenoses, or other appropriate vascular abnormalities. This International Standard is in addition applicable to delivery systems if they comprise an integral component of the deployment of the endovascular prostheses. |
| Keywords: | Acceptance specification|Cardiology|Definitions|Design|Endovascular|English language|Instructions for use|Marking|Materials|Medical devices|Medical equipment|Packages|Properties|Prosthetic devices|Specification (approval)|Sterile|Sterilization (hygiene)|Surgical implants|Testing|Vascular prostheses |
| ICS: | 11.040.40 - Implantes quirúrgicos, prótesis y ortesis |
| CTN: | |
|
Equivalencia Internacional |
Idéntica EN ISO 25539-1:2008 Idéntica ISO 25539-1:2003/Amd 1:2005 |
|
Reemplazo Normas |
Reemplaza a DIN EN 14299:2004-08 Reemplaza a DIN EN ISO 25539-1:2008-02 Es reemplazada por DIN EN ISO 25539-1:2009-08 |










