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ISO/TR 18965:2025

Medical devices — Examples of the application of the risk management process to cardiac valve replacement and repair systems ISO/TR 18965:2025

Publication date:   Feb 11, 2025

General information

60.60   Standard published   Feb 11, 2025

ISO

ISO/TC 150/SC 2 Cardiovascular implants and extracorporeal systems

Technical Report

11.040.40   Implants for surgery, prosthetics and orthotics

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Scope

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.

Life cycle

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PUBLISHED
ISO/TR 18965:2025
60.60 Standard published
Feb 11, 2025




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