| ISO 5840-2:2015 First Edition Cardiovascular implants - Cardiac valve prostheses - Part 2: Surgically implanted heart valve substitutes |
| Recognition Date | 2016-12-23 |
| Recognition List | 046 |
| Recognition Number | 3-147 |
| Extent | Partial recognition. The following part(s) of the standard is (are) not recognized Clause 7.2.4.2 Device durability assessment. Clause 7.2.4.3 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 |
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ISO 5840-2:2015 is applicable to heart valve substitutes intended for implantation in human hearts, generally requiring cardiopulmonary bypass and generally with direct visualization.
ISO 5840-2:2015 is applicable to both newly developed and modified surgical heart valve substitutes and to the accessories, packaging, and labelling required for their implantation and for determining the appropriate of the surgical heart valve substitute to be implanted.
ISO 5840-2:2015 outlines an approach for qualifying 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 may include those to assess the physical, chemical, biological, and mechanical properties of surgical heart valve substitutes and of their materials and components. The tests may also include those for pre-clinical in vivo evaluation and clinical evaluation of the finished surgical heart valve substitute.
| Regulation Number | Device Name | Device Class | Product Code |
| Unclassified | Heart-Valve, Mechanical | Class 3 | LWQ |
| Unclassified | Heart-Valve, Non-Allograft Tissue | Class 3 | LWR |
| §870.3925 | Replacement Heart-Valve | Class 3 | DYE |
| There is no relevant guidance developed at this time. |