ISO 81060-2 Blood Pressure Validation: Ensuring Accuracy in Non-Invasive BP Devices

Why ISO 81060-2 Matters for Accurate Blood Pressure Monitoring 

Non-invasive blood pressure devices must demonstrate dependable performance before developers can advance toward FDA or CE mark submissions. ISO 81060-2 “Non-invasive sphygmomanometers — Part 2: Clinical investigation of intermittent automated measurement type” sets a clear bar for clinical validation—defining study methods, reference comparisons, subject distribution, cuff/arm-size coverage, and prespecified accuracy criteria—so results are reproducible and defensible. 

For teams building wearables, cuff-based blood pressure monitors, or integrated platforms, aligning early to ISO 81060-2 sharpens protocol design and reporting, and produces evidence that maps cleanly to labeling and regulatory review. The result is accuracy claims anchored to a recognized standard for a clearer, more predictable path through regulatory review. 

What is ISO 81060-2 for Blood Pressure Validation? 

ISO 81060-2 outlines the methodology for verifying the accuracy of automated non-invasive intermittent sphygmomanometers or blood pressure monitors. It specifies who to enroll and how to measure blood pressure for regulatory approval. The standard defines: 

• Participant distribution requirements, including age ranges and systolic/diastolic pressure diversity. 

• Reference measurements collected using trained observers under good clinical practice (GCP) conditions. 

• Test sequences that assess device performance across multiple inflation–deflation cycles. 

• Data analysis, including mean error and standard deviation thresholds. 

• Protocol integrity, emphasizing transparent data handling and regulator-ready documentation. 

  
  

Compliance demands precise study execution, high-fidelity data collection, and closely monitored protocol alignment. 

Key Considerations When Planning an ISO 81060-2 Study 

Successful validation depends on more than meeting the baseline requirements of the standard. Device developers also must manage: 

1. Standard-Aligned Participant Recruitment 

Balanced representation across blood pressure categories is essential. Inclusive participant recruitment strengthens data quality and demonstrates equitable device performance. 

2. Reference Measurements with Clinical Precision 

Accurate arterial pressure or dual auscultation reference measurements require trained personnel and consistent methodology. Small inconsistencies can significantly affect dataset integrity and inflate error margins. 

3. IRB Oversight and Informed Consent 

Every clinical research study implementing ISO 81060-2 must secure IRB approval and ensure that informed consent processes comply with ethical and regulatory expectations. The informed consent is written in plain language that explains the study’s purpose, procedures, risks/benefits, and data use.   

4. Repeatability and Environmental Control 

Blood pressure shifts with posture, arm position, talking, and rest intervals. Standardized workflows—seated posture with back and feet supported, arm at heart level, defined rest periods, quiet room, stable temperature, consistent cuff placement, and scripted measurement sequences—reduce variability and allow performance to be attributed to the device under test. 

5. Integrating ISO 81060-2 With Adjacent Standards 

Many developers pair ISO 81060-2 with other regulatory frameworks such as ISO-14155 for GCP compliance. Early alignment across standards supports smoother FDA and CE mark filings and lowers the risk of costly submission revisions. 

6. Avoiding Delays in FDA Submission 

Regulatory reviewers frequently request clarification when data are incomplete, participant distributions are uneven, or measurement procedures lack traceability. Clear documentation, appropriate participant recruitment, a regulator-ready audit trail, and consistent protocol execution help prevent these common FDA submission delays. 

7. Using a Regulatory-Grade CRO for Blood Pressure Device Validation 

Working with a regulatory-grade CRO like PRL, experienced in single and multi-site clinical research studies, can strengthen each step of the process.  Transparent communication, early protocol alignment, a strong understanding of the standard, robust participant recruitment strategies, study execution, and audit-ready data analysis contribute to defensible clinical endpoints and streamlined FDA and CE review.  

Conclusion 

ISO 81060-2 remains one of the most important standards for non-invasive blood pressure device validation. When executed with precision, these studies deliver robust evidence of accuracy and help device developers advance efficiently toward regulatory clearance. 

PRL supports end-to-end ISO 81060-2 clinical research studies for Blood pressure validation: protocol development, IRB submission, inclusive recruitment, GCP compliance, harmonized execution, and submission-ready outputs. PRL works with your team to coordinate every step and produce reliable, clearly documented, regulator-ready results. Ready to get started? Contact us today!

*See Disclaimer regarding AI-generated content