Technical Report
ISO/TR 18965:2025
Medical devices — Examples of the application of the risk management process to cardiac valve replacement and repair systems
Reference number
ISO/TR 18965:2025
ISO/TR 18965:2025
Edition 1
2025-02
2025-02
© ISO 2025
Technical Report
Resumen
This document illustrates the implementation of the risk management process to the total product life cycle of cardiac valve replacement and repair systems. It provides specific examples of how risk management requirements and concepts can be applied to new or modified cardiac valve replacement and repair systems. The informative examples included herein are not exhaustive.
Informaciones generales
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Estado: PublicadoFecha de publicación: 2025-02Etapa: Norma Internacional publicada [60.60]
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Edición: 1Número de páginas: 19
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Comité Técnico :ISO/TC 150/SC 2ICS :11.040.40
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