AAMI/ISO 5840-1:2015

Applicable to heart valve substitutes intended for human implantation and provides general requirements. Subsequent parts provide specific requirements. 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 size of the heart valve substitute to be implanted. outlines an approach for qualifying the design and manufacture of a heart valve substitute through risk management.