ISO 5910: a new standard for valve repair devices
ISO 5910 has been created to address the emergence of numerous valve repair devices on the market. Previously ISO 5840, the only standard relating to heart valves, was focused solely on heart valve replacement.
Published in June 2018, ISO 5910 applies to all devices intended to “repair and/or improve the function of native human heart valves by acting either on the valve apparatus or on the adjacent anatomy (e.g. ventricle, coronary sinus).”
It is important to note that ISO 5910 does not apply to paravalvular leakage closure devices or systems (such as ablation) that do not leave an actual implant in place. The standard also excludes items used in general surgical practice such as sutures and patches.
As this is the first edition of ISO 5910 and this is a developing field, the standard is not overly prescriptive. Instead it relies on manufactures to continually evaluate and mitigate the risks of their devices.
ISO recommends that standards be updated every 5 years. We can expect the next release of the ISO 5910 standard around 2023. By this time valve repair technology will have matured another 5 years. Many lessons learned and many devices unimaginable today will be on the market. The second edition will likely include significant changes.