DIN EN ISO 14607:2026-02
Non-active surgical implants - Mammary implants - Specific requirements (ISO 14607:2024); German version EN ISO 14607:2025
| Fecha edición: |
2026-02-01
En Vigor
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|---|---|
| Idiomas disponibles: | Inglés, Alemán |
| Resumen: | This document specifies particular requirements for mammary implants. With regard to safety, this document specifies requirements for intended performance, design attributes, materials, design evaluation, manufacturing, packaging, sterilization, and information supplied by the manufacturer. |
| Keywords: | Abrasion|Accompanying leaflets|Biological hazards|Change of length|Checks|Chest (anatomy)|Clinical|Cohesion|Collisions|Construction details|Data of the manufacturer|Definitions|Design|Diffusion|Evaluations|Extensibility|Fabrics|Gels|Implants (surgical)|Inactive|Information|Labelling|Marking|Materials|Mechanical testing|Mechanics|Medical devices|Medical equipment|Medical instruments|Medical products|Medical sciences|Packages|Production|Safety|Safety requirements|Seams|Silicone|Specification (approval)|Status|Sterilization (hygiene)|Surfaces|Surgery|Surgical implants|Tear strength|Testing|Valves|Volume |
| ICS: | 11.040.40 - Implantes quirúrgicos, prótesis y ortesis |
| CTN: | |
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Equivalencia Internacional |
Idéntica EN ISO 14607:2025 Idéntica ISO 14607:2024 |
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Reemplazo Normas |
Reemplaza a DIN EN ISO 14607:2018-10 Reemplaza a DIN EN ISO 14607:2023-09 |
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