Reference measurement quality is foundational to a successful blood pressure validation study because every accuracy result depends on the strength of the reference. In ISO 81060-2 cuff-based validation, dual-observer auscultation is widely used as the reference method to support consistent systolic and diastolic blood pressure determination from Korotkoff sounds. This improves reproducibility across measurement sequences and produces clear, regulator-ready evidence for devic

What is a Blood Pressure Validation Study? Blood pressure devices cannot enter the market based solely on engineering performance or bench testing. Sponsors must demonstrate that device measurements are accurate when compared against validated clinical reference methods. A blood pressure validation study provides the clinical evidence needed to support FDA submissions, CE mark activities, and global regulatory acceptance. For cuff-based non-invasive blood pressure devices,

Why ISO 81060-2 Matters for Accurate Blood Pressure Monitoring Non-invasive blood pressure devices must demonstrate dependable performance before developers can advance toward FDA or CE mark submissions. ISO 81060-2 “Non-invasive sphygmomanometers — Part 2: Clinical investigation of intermittent automated measurement type ” sets a clear bar for clinical validation—defining study methods, reference comparisons, subject distribution, cuff/arm-size coverage, and prespecified