| ISO 5840-1 First edition 2015-09-15 Cardiovascular implants - Cardiac valve prostheses - Part 1: General requirements |
| Recognition Date | 2016-12-23 |
| Recognition List | 046 |
| Recognition Number | 3-145 |
| Extent | Complete standard |
| 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 |
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ISO 5840-1:2015 is applicable to heart valve substitutes intended for human implantation and provides general requirements. Subsequent parts of the ISO 5840?series provide specific requirements.
ISO 5840-1:2015 is applicable to both newly developed and modified heart valve substitutes and to the accessories, packaging, and labelling required for their implantation and for determining the appropriate of the heart valve substitute to be implanted.
ISO 5840-1:2015 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.
| Regulation Number | Device Name | Device Class | Product Code |
| Unclassified | Aortic Valve, Prosthesis, Percutaneously Delivered | Class 3 | NPT |
| Unclassified | Heart-Valve, Mechanical | Class 3 | LWQ |
| Unclassified | Heart-Valve, Non-Allograft Tissue | Class 3 | LWR |
| Unclassified | Prosthesis, Mitral Valve, Percutaneously Delivered | Class 3 | NPU |
| Unclassified | Pulmonary Valve Prosthesis Percutaneously Delivered | Class f | NPV |
| §870.3925 | Replacement Heart-Valve | Class 3 | DYE |
| There is no relevant guidance developed at this time. |