ISO-5840 › Cardiovascular implants - Cardiac valve prostheses
Show Complete Document History
The following bibliographic material is provided to assist you with your purchasing decision:
ISO 5840:2005 is applicable to all devices intended for implantation in human hearts, as a heart valve substitute.
It is applicable to both newly developed and modified heart valve substitutes and to the accessory devices, packaging and labelling required for their implantation and for determining the appropriate size of heart valve substitute to be implanted.
ISO 5840:2005 outlines an approach for qualifying the design and manufacture of a heart valve substitute through risk management. The selection of appropriate qualification tests and methods are derived from the risk assessment. The tests may include those to assess the physical, chemical, biological and mechanical properties of heart valve substitutes and of their materials and components. The tests may also include those for pre-clinical in vivo evaluation and clinical evaluation of the finished heart valve substitute.
ISO 5840:2005 imposes design specifications and minimum performance specifications for heart valve substitutes where adequate scientific and/or clinical evidence exists for their justification.
It excludes heart valve substitutes designed for implantation in artificial hearts or heart assist devices.
To find similar documents by classification:
This document comes with our free Notification Service, good for the life of the document.
This document is available in either Paper or PDF format.
Customers who bought this document also bought:
ASTM-D4169Standard Practice for Performance Testing of Shipping Containers and Systems
ASTM-F88
Standard Test Method for Seal Strength of Flexible Barrier Materials
ASTM-F1980
Standard Guide for Accelerated Aging of Sterile Barrier Systems and Medical Devices
Document Number
ISO 5840:2005
Revision Level
4TH EDITION
Status
Superseded
Publication Date
March 1, 2005
Committee Number
ISO/TC 150/SC 2