Heart Valve Testing

The standards for heart valve testing are issued by the ISO committee for Cardiovascular Implants and are available for purchase at www.aami.org. The current standards require material, component, and valve assembly testing, hydrodynamic testing, durability testing, preclinical in vivo and clinical evaluation; along with packaging, labeling, and instructions requirements.

The durability test requirements in the 1996 revision of the ISO 5840 standard states the three valves of the smallest, medium, and largest size valves should be tested alongside a reference valve under identical conditions. The valves should be inspected at least every 50 million cycles. Mechanical heart valves should attain 380 million cycles of testing and biological valves should attain 200 million cycles of testing.

AAMI/ISO has recently reconvened the heart valve testing standards committee to complete a major overhaul of ISO 5840. This new standard will be composed of three distinct sections: the first for standard heart valves will be similar to the current document, the second section will specifically address percutaneously delivered heart valve replacements and the third will cover heart valve repair devices such as annuloplasty rings.


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