DIN EN ISO 5840-1:2025-10
Cardiovascular implants - Cardiac valve prostheses - Part 1: General requirements (ISO 5840-1:2021 + Amd 1:2025); German version EN ISO 5840-1:2021 + A1:2025 / Note: Applies in conjunction with DIN EN ISO 5840-2 (2025-10), DIN EN ISO 5840-3 (2025-10).
| Fecha edición: |
2025-10-01
En Vigor
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| Idiomas disponibles: | Inglés, Alemán |
| Resumen: | This document is applicable to heart valve substitutes intended for human implantation and provides general requirements. Subsequent parts of this International Standard provide specific requirements. This document is applicable to both newly developed and modified heart valve substitutes and to the accessories, packaging, and labelling required for their implantation and for determining the appropriate size of the heart valve substitute to be implanted. This document outlines an approach for qualifying the design and manufacture of a heart valve substitute through risk management. The selection of appropriate qualification tests and methods are derived from the risk assessment. The tests may include those to assess the physical, chemical, biological, and mechanical properties of heart valve substitutes and of their materials and components. The tests may also include those for pre-clinical in vivo evaluation and clinical evaluation of the finished heart valve substitute. This document defines operational conditions for heart valve substitutes. This document excludes homografts. |
| Keywords: | Accessories|Cardiac valves|Cardiology|Chemical properties|Definitions|Design|Dimensions|Durability|Endurance tests|Evaluations|Fine mechanics|Heart|Implants (surgical)|In vitro|In vivo|Inspection|Marking|Material tests|Materials|Measurement|Medical devices|Medical technology|Packages|Physical properties|Production|Properties|Prosthetic devices|Quality assurance|Risk|Risk management|Specification (approval)|Sterilization (hygiene)|Surgical implants|Testing|User information|Validation|Vascular prostheses|Verification |
| ICS: | 11.040.40 - Implantes quirúrgicos, prótesis y ortesis |
| CTN: | |
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Equivalencia Internacional |
Idéntica EN ISO 5840-1:2021/A1:2025 Idéntica ISO 5840-1:2021/Amd 1:2025 |
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Reemplazo Normas |
Reemplaza a DIN EN ISO 5840-1:2021-05 Reemplaza a DIN EN ISO 5840-1/A1:2024-03 |
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