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ANSI/AAMI/ISO 5840-3:2022

Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by transcatheter techniques

This document establishes an approach for verifying/validating the design and manufacture of a surgical heart valve substitute through risk management. The selection of appropriate qualification tests and methods are derived from the risk assessment. The tests can include those to assess the physical, chemical, biological, and mechanical properties of surgical heart valve substitutes and of their materials and components. The tests can also include those for pre-clinical in vivo evaluation and clinical evaluation of the finished surgical heart valve substitute. This document includes considerations for implantation of a transcatheter heart valve substitute inside pre-existing prosthetic device configurations.

CONTENT PROVIDER
Association for the Advancement of Medical Instrumentation [aami]

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Cardiovascular implants - Cardiac valve prostheses - Part 1: General requirements
Cardiovascular implants - Cardiac valve prostheses - Part 2: Surgically implanted heart valve substitutes
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