ISO/TR 18965:2025

International Standard   Current Edition · Approved on 11 February 2025

Medical devices — Examples of the application of the risk management process to cardiac valve replacement and repair systems

ISO/TR 18965:2025 Files

English 19 Pages
Current Edition
USD 170.29

ISO/TR 18965:2025 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.

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