Key result
Hydrodynamic performance testing via a pulse duplicator system is a major in vitro requirement of the 2021 ISO 5840 standard for approving newly developed heart valve prostheses.
Why the study?
A new version of the ISO 5840-family was published in 2021 for approval-relevant testing to prove the safety and effectiveness of newly developed heart valve prostheses.
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Population
Newly developed heart valve prostheses
Design
In vitro hydrodynamic cardiovascular test bench study
Describes the in vitro hydrodynamic performance testing of heart valve prostheses according to the 2021 ISO 5840 standard.
For the approval-relevant testing to prove the safety and effectiveness of newly developed heart valve prostheses, a new version of the ISO 5840-family was published in 2021. One of the major in vitro tests in this standard is the investigation of the hydrodynamic performance of heart valve prostheses by means of a hydrodynamic cardiovascular test bench (pulse duplicator system).
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Kaule et al. (2022) studied this question. Hydrodynamic performance testing via a pulse duplicator system is a major in vitro requirement of the 2021 ISO 5840 standard for approving newly developed heart valve prostheses.
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