DIN EN ISO 5840-3:2025-10
Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by transcatheter techniques (ISO 5840-3:2021 + Amd 1:2025); German version EN ISO 5840-3:2021 + A1:2025 / Note: Applies in conjunction with DIN EN ISO 5840-1 (2025-10), DIN EN ISO 5840-2 (2025-10).
| Fecha edición: |
2025-10-01
En Vigor
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| Idiomas disponibles: | Inglés, Alemán |
| Resumen: | This document specifies requirements for all devices intended for implantation in human hearts as a minimally invasive implanted heart valve substitute. This document is applicable to both newly developed and modified minimally invasive implanted heart valve substitutes and to the accessory devices, packaging and labeling required for their implantation and for determining the appropriate size of heart valve substitute to be implanted. It outlines an approach for qualifying the design and manufacture of a minimally invasive heart valve substitute through risk management. The selection of appropriate qualification tests and methods are to be 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 preclinical in vivo evaluation and clinical evaluation of the finished heart valve substitute. This document imposes design specifications and minimum performance specifications for minimally invasive implanted heart valve substitutes where adequate scientific and/or clinical evidence exists for their justification. This document is not applicable to heart valve substitutes designed for implantation in artificial hearts or heart assist devices and does not specifically address requirements for valve-in-valve configurations. |
| Keywords: | Cardiac valves|Cardiology|Chemical properties|Definitions|Design|Dimensions|Durability|Endurance tests|Evaluations|Fine mechanics|Heart|Implants (surgical)|In vitro|In vivo|Inspection|Invasive|Marking|Material tests|Materials|Measurement|Medical devices|Medical technology|Packages|Physical properties|Properties|Prosthetic devices|Quality assurance|Risk|Specification (approval)|Sterilization (hygiene)|Substitutes|Surgical implants|Testing|User information|Vascular prostheses|Verification |
| ICS: | 11.040.40 - Implantes quirúrgicos, prótesis y ortesis |
| CTN: | |
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Equivalencia Internacional |
Idéntica EN ISO 5840-3:2021/A1:2025 Idéntica ISO 5840-3:2021/Amd 1:2025 |
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Reemplazo Normas |
Reemplaza a DIN EN ISO 5840-3:2021-05 Reemplaza a DIN EN ISO 5840-3/A1:2024-03 |
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