Full Description

ISO 5840-1:2021 is applicable to heart valve substitutes intended for human implantation and provides general requirements. Subsequent parts of the ISO 5840 series provide specific requirements.

ISO 5840-1:2021 is 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.