AAMI/ISO 5840-1:2015

Cardiovascular implants - Cardiac valve prostheses - Part 1: General Requirements

standard by Association for the Advancement of Medical Instrumentation/International Org. for Standardization , 11/16/2015

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Full Description

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 preclinical in vivo evaluation and clinical evaluation of the finished heart valve substitute.

Product Details

Published:: 11/16/2015
ANSI:: ANSI Approved
Number of Pages:: 67
File Size:: 1 file , 950 KB
Note:: This product is unavailable in Ukraine, Russia, Belarus

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