DIN EN ISO 5840:2009-08

This International Standard imposes design specifications and minimum performance specifications for heart valve substitutes. It is applicable to both newly developed and modified heart valve substitutes and to the accessory devices, packaging and labelling required for their implantation and for determining the appropriate size of the heart valve substitute to be implanted. An approach for qualifying the design and manufacture of a heart valve substitute through risk management is given. The selection of appropriate qualification 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 standard excludes heart valve substitutes designed for implantation in artificial hearts or heart assist devices.