
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
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
Format 
Secure PDF
Secure – PDF details
- Save your file locally or view it via a web viewer
- Viewing permissions are restricted exclusively to the purchaser
- Device limits - 3
- Printing – Enabled only to print (1) copy
See more about our Environmental Commitment
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.
Previous Editions
Can’t find what you are looking for?
Please contact us at:
Related Documents
-

ISO 16840:2023 Wheelchair seating – Part 14: Concepts related to managing external forces to maintain tissue integrity
CDN $129.00 Add to cart -

ISO 24096:2024 Technical product documentation (TPD) – Classification of requirements – Part 2: Classification based on severity and susceptibility
CDN $259.00 Add to cart -

ISO 20712:2024 Water safety signs and beach safety flags – Part 3: Guidance for use
CDN $259.00 Add to cart -

ISO 21531:2009 Dentistry – Graphical symbols for dental instruments
CDN $192.00 Add to cart







