ISO 81060-3 Clinical Validation for Continuous Blood Pressure Monitoring

Why ISO 81060-3 Matters for Continuous Blood Pressure Devices 

Continuous non-invasive blood pressure monitoring is fundamentally different from intermittent cuff readings. Instead of producing a single systolic and diastolic value at discrete time points, continuous systems output frequent blood pressure estimates and trends over time. 

ISO 81060-3 defines the clinical validation framework for evaluating continuous non-invasive blood pressure devices under standardized conditions. For sponsors preparing for regulatory review, the standard provides a structured method for generating evidence that supports credible performance claims. 

Devices Where ISO 81060-3 Applies 

ISO 81060-3 applies to continuous non-invasive sphygmomanometers that estimate blood pressure from cardiac cycles and provide a continuing series of blood pressure values. Devices with output periods substantially longer than 30 seconds are generally not considered continuous under this definition. 

The standard also distinguishes between two device categories, which shape how performance is evaluated: 

• Type A: intended to provide accurate blood pressure determinations; evaluated for accuracy, stability, and blood pressure change performance.  

• Type T: intended to track trends; evaluated for stability and blood pressure change performance. 

What the Clinical Investigation Evaluates 

ISO 81060-3 structures evaluation around continuous performance rather than single readings. In practical terms, studies are designed to assess: 

• Baseline performance, including agreement with the reference under defined conditions 

• Stability over time, particularly for devices that rely on initialization  

• Performance during blood pressure changes 

Arterial Blood Pressure as the Reference 

ISO 81060-3 requires reference invasive blood pressure monitoring equipment (intra-arterial monitoring) for the clinical investigation of continuous non-invasive blood pressure devices. This reference provides beat-to-beat arterial pressure values and a waveform, enabling time-aligned paired measurements from the same cardiac cycles for systolic, diastolic, and mean arterial pressure (MAP) comparisons. 

Participant Recruitment Requirements 

ISO 81060-3 includes requirements to ensure enrolled participants reflect relevant physiological variability. Studies are planned with prespecified distributions, so results are not limited to narrow, normotensive conditions. In practice, this includes: 

• Prespecified representation across age ranges and sex 

• Defined blood pressure range coverage  

• Consideration of special populations, when relevant to the intended use 

Clinical Research Standards and Documentation 

Programs intended for regulatory submission are conducted under established frameworks, including ISO 14155 and Good Clinical Practice (GCP), with IRB oversight and informed consent. These controls protect participant safety and ensure that the resulting dataset is traceable and inspection-ready. 

Conclusion 

ISO 81060-3 defines a clear, clinical validation test for continuous non-invasive blood pressure technologies. By requiring arterial line reference measurements and emphasizing time-aligned comparisons and stability evaluation, the standard supports reproducible evidence that maps to intended use and regulatory review. Early alignment to ISO 81060-3 during clinical trial protocol development helps ensure that final results are interpretable, traceable, and regulator-ready. 

Ready to discuss your study requirements? Contact PRL today!