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
Edition 1
2025-02
© ISO 2025
Technical Report
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Published (Edition 1, 2025)

ISO/TR 18965:2025

Language
Format
CHF 132
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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.

General information

  • Status
     : Published
    Publication date
     : 2025-02
    Stage
    : International Standard published [60.60]
  • Edition
     : 1
    Number of pages
     : 19
  • Technical Committee :
    ISO/TC 150/SC 2
    ICS :
    11.040.40 
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Life cycle

Sustainable Development Goals

This standard contributes to the following Sustainable Development Goal

3
Good Health and Well-being

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