ISO 81060-3:2022

Overview

ISO 81060-3:2022 - "Non‑invasive sphygmomanometers - Part 3: Clinical investigation of continuous automated measurement type" defines requirements and methods for clinical investigations of continuous automated non‑invasive sphygmomanometers (continuous NIBP devices). The standard focuses on validating device performance for measuring systolic, diastolic and mean arterial pressure in clinical populations. It does not cover usability, output representation or invasive monitoring, and devices with output periods considerably longer than 30 s are typically not considered continuous under this standard.

Key topics and technical requirements

• Clinical investigation scope: Procedures and acceptance criteria for clinical trials that demonstrate device performance across intended subject populations and conditions of use.
• Reference methods: Use of appropriate arterial reference methods (including invasive reference where applicable) and clear specification of arterial reference site.
• Accuracy assessment: Methods to evaluate absolute accuracy and trending capability of continuous automated NIBP devices.
• Stability and change tracking: Tests for temporal stability and for the device’s ability to track blood pressure changes over defined change evaluation intervals.
• Lateral difference procedures: Guidance on sequential and simultaneous measurement procedures to account for inter‑arm differences.
• Statistical considerations: Requirements for sample size, intra‑class correlation, number of independent measurements, and data analysis methods to ensure robust conclusions.
• Good clinical practice & risk management: Clinical investigations must align with ISO 14155 and ISO 14971; IEC 62366‑1 is referenced for usability engineering (clarifying trending vs. absolute readings).
• Disclosure requirements: Additional labeling or documentation disclosures for devices that have undergone clinical investigation per ISO 81060‑3.

Note: ISO 81060‑3 excludes assessment of artifact effects (e.g., motion artefacts) within the clinical investigation methods.

Applications and users

ISO 81060‑3:2022 is intended for:

• Medical device manufacturers developing continuous NIBP monitors (bedside, ambulatory or perioperative monitoring).
• Clinical researchers designing and conducting validation studies to support regulatory submissions.
• Regulatory and conformity assessment bodies reviewing clinical evidence for device approval or CE/market clearance.
• Hospital procurement and clinical engineering teams evaluating device claims for accuracy, stability and trending performance.

Practical use cases include validating continuous cuffless or cuff‑based continuous monitors used in critical care, anesthesia, telemetry wards, and research settings where continuous blood pressure trend and/or absolute accuracy are required.

Related standards

• ISO 14155:2020 - Clinical investigation of medical devices (Good Clinical Practice)
• ISO 14971:2019 - Risk management for medical devices
• ISO 81060‑1 / ISO 81060‑2 - Non‑invasive sphygmomanometers (non‑automated and intermittent automated types)
• IEC 80601‑2‑30 and IEC 60601‑2‑34 - Particular requirements for non‑invasive and invasive blood pressure devices
• IEC 62366‑1 - Usability engineering for medical devices

This standard helps ensure clinically relevant, statistically robust evidence for continuous blood pressure monitoring devices and supports safer, more reliable NIBP device deployment.