Updated practical guide for validation studies of automated cuff blood pressure monitors according to the Universal Standard by the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization (ISO 81060-2:2018) and Amendments 1:2020 and 2:2024.

Abstract

Validated blood pressure (BP) monitors are essential for the accurate diagnosis and management of hypertension. In 2018, the Association for the Advancement of Medical Instrumentation (AAMI), the European Society of Hypertension (ESH), and the International Organization for Standardization (ISO) introduced the AAMI/ESH/ISO Universal Standard (ISO 81060-2:2018) to establish globally accepted requirements for validation studies. This standard is developed specifically for cuff BP devices and is inadequate for cuffless ones, which require different validation procedures. In 2018, the ESH Working Group on Blood Pressure Monitoring published a practical guide and checklist for performing and reporting validation studies of cuff BP devices. Thereafter, two recent amendments (1:2020 and 2:2024) introduced additional requirements for limb and cuff size distribution to ensure that the entire limb range per cuff is adequately assessed. Despite these major initiatives, regular reviews of published validation studies performed by STRIDE BP have identified persistent violations of the validation requirements and incomplete reporting of important data. This statement, prepared by STRIDE BP and the ESH Working Group on Blood Pressure Monitoring, provides an updated guide and checklists, which are complementary to our 2019 guide and aim at assisting investigators and reviewers in performing and reporting high-quality validation studies of cuff BP devices that comply with the latest requirements by the AAMI/ESH/ISO Universal Standard.