BSI 20/30368566 DC 2020

This document is applicable to all intracardiac occluders intended for transcatheter implantation in humans (e.g. atrial septal occluder, ventricular septal occluder, patent foramen ovale occluder, and left atrial appendage occluder, and paravalvular leak occluders). This document does not cover non-cardiac occluders, but elements of this standard might be applicable to occluders for patent ductus arteriosus.

The following devices and components are outside the scope of this standard: surgical devices, cardiac shunt devices, atrial flow regulators, active components (such as sensors), or degradable or animal tissue components.

This document is applicable to both newly developed and modified cardiac occluders, their accessory devices, packaging, and labelling.

This document defines operational conditions and performance requirements for cardiac occluders where adequate scientific and/or clinical evidence exists for their justification.

At the time of publishing this document, it is impossible to take all future and emerging technologies into consideration. The cardiac occluder systems based on these new technologies will need to be evaluated following the basic requirements of this standard. Testing beyond the scope of this standard might also be necessary in order to verify and validate these cardiac occluder systems.