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B51-14 (R2019) – Boiler, pressure vessel, and pressure piping code

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ISO 18965:2025

ISO 18965:2025 Medical devices – Examples of the application of the risk management process to cardiac valve replacement and repair systems

CDN $259.00

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Description

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.

Edition

1

Published Date

2025-02-11

Status

PUBLISHED

Pages

19

Language Detail Icon

English

Format Secure Icon

Secure PDF

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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