Overview
EN ISO 81060-2:2019/A2:2024 is Amendment 2 to the international standard for non‑invasive sphygmomanometers - Part 2: Clinical investigation of intermittent automated measurement type. Published by CEN and aligned with ISO 81060-2:2018/Amd 2:2024, this amendment updates clinical investigation requirements for automated intermittent blood‑pressure devices, with specific additions on cuff evaluation, subject selection and data reporting.
Key topics and technical requirements
- Scope clarification: The amendment specifies that clinical investigations do not cover sets of cuffs that differ in materials or construction - each distinct cuff set must be evaluated separately.
- Subject rules: All study participants must be unique and each subject may be used in only one clinical investigation.
- Measurement count per subject: For each patient, at least 5 but no more than 10 valid blood‑pressure measurements are required.
- Limb (arm) size distribution: New, detailed rules define how subjects must be distributed across cuff limb‑circumference ranges:
- Different procedures apply depending on cuff range (≤12 cm, >12–≤16 cm, >16 cm).
- Percentile targets (upper/lower halves, quartiles, octiles) are required to ensure coverage across a cuff’s specified arm range.
- Where multiple cuff sizes are used, overlap among cuffs must meet the limit in Formula (17); if not, separate clinical investigations with cuff subsets are required.
- Minimum sample sizes per cuff are defined by the amendment (with fallback minimums specified where calculated N is small).
- Reporting and plots:
- Reports must state each cuff’s specified arm circumference range.
- Provide plots of device-minus-reference blood‑pressure difference versus actual arm circumference (with vertical lines for cuff limits and distinct symbols/colors per cuff) for systolic and diastolic values (and MAP if the device provides it).
- Include Bland–Altman plots (difference vs average) for systolic and diastolic pressures.
- Conformance check: Clinical investigation reports are to be inspected for compliance with these data, distribution and reporting requirements.
Applications and users
This amendment is essential for:
- Device manufacturers preparing clinical validation for automated non‑invasive blood‑pressure monitors.
- Clinical investigators and test laboratories designing and running validation studies.
- Regulatory and conformity assessment bodies reviewing clinical evidence for CE marking and national approvals.
- Medical device consultants and quality teams responsible for clinical evaluation reports and technical documentation.
Keywords: EN ISO 81060-2:2019/A2:2024, non-invasive sphygmomanometers, clinical investigation, blood pressure validation, cuff limb circumference, Bland‑Altman, medical device testing.
Related standards
- ISO 81060 series (Part 1 and Part 2)
- EN ISO 81060-2:2019 (original version) - Amendment A2 updates and refines its clinical investigation requirements.
