DIN EN ISO 25539-1:2018-05
Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses (ISO 25539-1:2017); German version EN ISO 25539-1:2017 / Note: DIN EN ISO 25539-1 (2017-09) and DIN EN ISO 25539-1 (2009-08) remain valid alongside this standard until 2020-03-15.
| Fecha edición: |
2018-05-01
En Vigor
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| 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|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: | |
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Equivalencia Internacional |
Idéntica ISO 25539-1:2017 Idéntica EN ISO 25539-1:2017 |
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Reemplazo Normas |
Reemplaza a DIN EN ISO 25539-1:2017-09 |










