ISO 81060-2 Blood Pressure Device Validation Explained

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 standardized posture, rest, and cuff placement 

• Reference measurements collected using trained observers and dual auscultation 

• Prespecified participant recruitment criteria and blood pressure range coverage 

• Statistical evaluation of accuracy using defined acceptance criteria 

Together, these elements support consistent, reproducible evaluation across studies. 

Participant Recruitment Requirements 

The standard defines requirements for recruiting participants across a range of systolic and diastolic blood pressure values. This distribution helps ensure accurate conclusions reflect the full spectrum of physiological conditions relevant to intended use. 

Supporting Medical Device Validation 

ISO 81060-2 establishes a standardized clinical framework for intermittent automated blood pressure monitors, ensuring accuracy is evaluated using consistent methods and acceptance criteria. This standardization supports clear performance claims during regulatory review.