ANSI/AAMI/ISO 5840-1:2015 [HISTORICAL]

This document 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. This document has been superseded by  ANSI/AAMI/ISO 5840-1:2022, Cardiovascular implants—Cardiac valve prostheses—Part 1: General requirements. This document is no longer being maintained by AAMI and should not be used for new designs.  Every AAMI standard is subjected to review at least every five (5) years. When a standard is more than five years old, has not undergone revision or review, and/or no longer carries the ANSI designation, it is reasonable to conclude that the contents, while still of some historic value, do not reflect the present state of the art. All copyrights remain in full effect. Annex 2