Blood pressure validation studies depend on a reference method that is clinically grounded and repeatable. For intermittent blood pressure devices, that reference is often manual auscultation, where trained observers use a cuff and stethoscope to determine systolic and diastolic pressure based on Korotkoff sounds. These sounds provide the clinical signal used to identify the points at which blood flow first returns and then becomes silent again as the cuff deflates. For inte

Planning a Blood Pressure Validation Study Designing a blood pressure validation study requires careful planning to support reliable measurement comparisons. Early clinical trial protocol development should clearly define the device’s intended use, primary accuracy endpoints, and reference method used for comparison. This up-front structure helps keep study execution, data collection, and reporting consistent from the first participant through the final report. Key Eleme

What Is ISO 81060-2? ISO 81060-2 is an international standard that defines how to clinically validate intermittent automated non-invasive blood pressure devices. It establishes the study framework used to determine whether a device’s systolic and diastolic readings align with qualified reference measurements under standardized conditions. Key Components of the Standard Validation studies conducted under ISO 81060-2 typically include: Structured measurement sequences using

The Importance of High-Resolution Reference Measurements Blood pressure validation studies require reference measurements that accurately reflect physiological conditions. While auscultatory measurements provide reliable values, some studies require continuous high-resolution monitoring. In these cases, researchers may use arterial line monitoring. What Is Arterial Line Monitoring? An arterial catheter allows researchers to measure blood pressure directly within an art