AAMI/ISO 5840-2:2015

Applicable to heart valve substitutes intended for implantation in human hearts, generally requiring cardiopulmonary bypass and generally with direct visualization. Applicable to both newly developed and modified surgical heart valve substitutes and to the accessories, packaging, and labeling required for their implantation and for determining the appropriate size of the surgical heart valve substitute to be implanted. Outlines an approach for qualifying the design and manufacture of a surgical heart valve substitute through risk management.