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

Why Reference Measurements Matter Every blood pressure validation study relies on a reliable reference method to evaluate device accuracy. A trusted reference measurement provides the foundation for determining whether a monitoring device delivers accurate and clinically meaningful readings. At Parameters Research Laboratory (PRL), reference measurements are conducted by highly trained clinical research staff with deep experience in physiological monitoring studies. This lev

Blood Pressure Device Validation Studies Accurate blood pressure measurement is fundamental to physiological monitoring. As new technologies expand beyond traditional cuffs into wearable and cuffless blood pressure devices, sponsors must demonstrate performance using a structured blood pressure validation study. These studies evaluate how closely a device’s measurements align with reference measurements obtained through established clinical methods and generate the evidence r