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
OMR
65.76
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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