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  4. Standard "ISO/TR 18965:2025"
Standard ISO/TR 18965:2025 11.2.2025 preview

ISO/TR 18965:2025

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

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STANDARD published on 11.2.2025


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The information about the standard:

Designation standards: ISO/TR 18965:2025
Publication date standards: 11.2.2025
SKU: NS-1213366
The number of pages: 19
Approximate weight : 57 g (0.13 lbs)
Country: International technical standard
Category: Technical standards ISO

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The category - similar standards:

Implants for surgery, prosthetics and orthotics

Annotation of standard text ISO/TR 18965:2025 :

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.

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