Medical devices — Examples of the application of the risk management process to cardiac valve replacement and repair systems
STANDARD published on 11.2.2025
Designation standards: ISO/TR 18965:2025
Publication date standards: 11.2.2025
The number of pages: 19
Approximate weight : 57 g (0.13 lbs)
Country: International technical standard
Category: Technical standards ISO
Description / Abstract: 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.