Parameters Research Laboratory (PRL) conducts cuff-based non-invasive blood pressure (NIBP) studies in accordance with ISO 81060-2, supporting device development, verification, and regulatory validation. Our team brings extensive hands-on experience executing standards-compliant protocols, with a strong understanding of both the technical and operational details required to generate high-quality, submission-ready datasets. 

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A defining strength of PRL’s cuff-based studies is our deep expertise in dual-observer auscultation, the reference method central to ISO 81060-2 validation. Our staff have conducted dual auscultation studies for over 15 years, with observers trained in the identification of Korotkoff sounds in accordance with the 1993 BHS protocol, including a formal qualification using 50 reference measurements. Across our clinical trials, inter-observer differences remain within 4 mmHg for both systolic and diastolic blood pressure in 99.7% of paired measurements, reflecting a consistently high level of reference accuracy and methodological rigor.