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BS EN ISO 5840:2009 | 31 Oct 2009 | BSI Knowledge
Standard
Designated
Withdrawn
BS EN ISO 5840:2009
Cardiovascular implants. Cardiac valve prostheses
Published:
31 Oct 2009
•
Withdrawn:
31 Oct 2015
Overview
Preview
References
History
1 Scope
1.1
This International Standard is applicable to all devices intended for implantation in human hearts, as a
heart valve substitute
.
Product Details
Descriptors
Verification
Instructions for use
Prosthetic devices
Medical equipment
Physical properties of materials
Hazards
Cardiology
Packaging
Sterilization (hygiene)
In vivo testing
Reports
Classification systems
Prosthesis
Circulatory system
Performance
Risk assessment
Performance testing
Heart
Design
Clinical testing
Life (durability)
Acceptance (approval)
Implants (surgical)
Labels
Valves
ICS Codes
11.040.40 Implants for surgery, prosthetics and orthotics
Committee
CH/150/2
International relationships
Identical to:
EN ISO 5840:2009
ISO 5840:2005
ISBN
978 0 580 68135 6
Publisher
BSI