DIN EN ISO 7197:2025-02
Neurosurgical implants - Sterile, single-use hydrocephalus shunts (ISO 7197:2024); German version EN ISO 7197:2024
| Fecha edición: |
2025-02-01
En Vigor
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|---|---|
| Idiomas disponibles: | Inglés, Alemán |
| Resumen: | This document specifies safety and performance requirements for sterile, single-use non-active hydrocephalus shunts. This includes not only the valve, but also additional components such as tubes and reservoirs. This document gives no recommendation concerning the superiority of a certain type of valve. For manufacturing, it specifies the mechanical and technical requirements. This document specifies the technical information supplied by the manufacturer, including the technical information of the valve. In respect to the principles of the different valve types, this document specifies characteristics for each type. The benefit of this document for the surgeon and the patient is to understand the information given by the manufacturer and to obtain standardized information about the performance of a well working product with new design characteristics. The benefit for the manufacturer is to specify the important requirements for shunts as a basis for investigations during development as well as for quality control during manufacture. This document does not apply to active implants for the treatment of hydrocephalus. |
| Keywords: | CE marking|Data of the manufacturer|Definitions|Designations|Enterprises|Equipment for single use|Hoses|Implants (surgical)|Instructions for use|Labelling (process)|Marking|Medical devices|Medical equipment|Medical instruments|Medical sciences|Medical technology|Neurology|Packages|Quality control|Specification (approval)|Specifications|Sterile equipment|Surgery|Surgical implants|User information|Valves |
| ICS: | 11.040.40 - Implantes quirúrgicos, prótesis y ortesis |
| CTN: | |
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Equivalencia Internacional |
Idéntica EN ISO 7197:2024 Idéntica ISO 7197:2024 |
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Reemplazo Normas |
Reemplaza a DIN EN ISO 7197:2009-08 Reemplaza a DIN EN ISO 7197:2023-07 |
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