DIN EN ISO 25539-2:2021-01
Cardiovascular implants - Endovascular devices - Part 2: Vascular stents (ISO 25539-2:2020); German version EN ISO 25539-2:2020
| Fecha edición: |
2021-01-01
En Vigor
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|---|---|
| Idiomas disponibles: | Inglés, Alemán |
| Resumen: | This document has been prepared to provide minimum requirements for vascular stents. The normative requirements are provided in the main body. The rationale for the requirements for bench tests and analyses to assess device performance, guidance on the identification of appropriate testing to evaluate a specific device design, and guidance for developing test methods are provided in informative annexes. Further clarification of terminology is provided in additional informative annexes. |
| Keywords: | Cardiology|Construction details|Definitions|Endovascular|Evaluations|Implants (surgical)|Information supplied by the manufacturer|Instructions for use|Marking|Medical devices|Medical equipment|Medical sciences|Packages|Prosthetic devices|Specification (approval)|Stents|Surgery|Surgical implants|Vascular prostheses|Vascular stents |
| ICS: | 11.040.40 - Implantes quirúrgicos, prótesis y ortesis |
| CTN: | |
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Equivalencia Internacional |
Idéntica EN ISO 25539-2:2020 Idéntica ISO 25539-2:2020 |
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Reemplazo Normas |
Reemplaza a DIN EN ISO 25539-2:2013-05 Reemplaza a DIN EN ISO 25539-2:2019-07 |
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