| ISO 5840-3 First edition 2013-03-01 Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by transcatheter techniques |
| Recognition Date | 2016-04-04 |
| Recognition List | 041 |
| Recognition Number | 3-133 |
| Extent | Partial recognition. The following part(s) of the standard is (are) not recognized Clause 7.2.4.2 Device structural component fatigue assessment. |
| Standards Orgs | ISO International Organization for Standardization https://www.iso.org/ |
| STG | Cardiovascular |
| FDA Tech | Changfu Wu FDA/OMPT/CDRH/ODE/DCD/SHDB/ 301-796-6086 changfu.wu@fda.hhs.gov |
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies. Section 7.2.4.2 conflicts with section In Vitro Testing in reference listed below.
SO 5840-3:2013 outlines an approach for verifying/validating the design and manufacture of a transcatheter heart valve substitute through risk management. The selection of appropriate verification/validation tests and methods are to be 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 can also include those for preclinical in vivo evaluation and clinical evaluation of the finished heart valve substitute.
| Regulation Number | Device Name | Device Class | Product Code |
| Unclassified | Aortic Valve, Prosthesis, Percutaneously Delivered | Class 3 | NPT |
| Unclassified | Prosthesis, Mitral Valve, Percutaneously Delivered | Class 3 | NPU |
| Unclassified | Pulmonary Valve Prosthesis Percutaneously Delivered | Class f | NPV |
| Fernando A, Hillebrenner M, Stewart S, Swain J, Hampshire V, Zuckerman B (2011). U.S. Regulatory Considerations for Heart Valves Implanted by Minimally Invasive Surgery. Cardiovascular Engineering and Technology, 2(2): 62-5. |