UNE-EN ISO 5840-1:2021

This part of ISO 5840 is applicable to heart valve substitutes intended for implantation andprovides general requirements. Subsequent parts of the ISO 5840 series provide specificrequirements.ISO 5840 is applicable to: newly developed and modified heart valve substitutes; theaccessory devices, packaging, and labelling required for their implantation; and fordetermining the appropriate size of the heart valve substitute to be implanted.ISO 5840 outlines an approach for verifying/validating the design and manufacture of aheart valve substitute through risk management. The selection of appropriate qualificationtests and methods are derived from the risk assessment. The tests may include those toassess the physical, chemical, biological, and mechanical properties of heart valvesubstitutes and of their materials and components. The tests can also include those forpreclinical in vivo evaluation and clinical evaluation of the finished heart valve substitute.ISO 5840 defines operational conditions for heart valve substitutes.ISO 5840 does not provide requirements specific to homografts, tissue engineered heartvalves (e.g. valves intended to regenerate in vivo), and heart valve substitutes designed forimplantation in circulatory support devices.NOTE: A rationale for the provisions of ISO 5840 is given in Annex A.