ISO 81060-2:2018

Overview

ISO 81060-2:2018 specifies requirements and methods for the clinical investigation of intermittent non‑invasive automated sphygmomanometers (cuff‑based devices that estimate arterial blood pressure). The standard applies to devices that sense or display pulsations, flow or sounds for blood‑pressure estimation - whether or not they have automatic cuff inflation - and covers use across all patient populations and conditions (ambulatory monitoring, exercise stress testing, home/self‑measurement and professional healthcare settings).

Key topics and technical requirements

• Clinical investigation methods: Devices shall be clinically investigated in each mode of operation (e.g., adult vs neonatal mode, different cuff deflation rates). Investigations may use either a non‑invasive auscultatory reference sphygmomanometer or a reference invasive blood‑pressure monitoring system.
• Reference measurement: If a device estimates central/aortic pressure, a central/aortic invasive reference site is required.
• Subject and population requirements: Protocols must address subject number, gender and age distribution, limb (arm) size distribution, and blood‑pressure distribution. Special patient groups (e.g., pregnant patients) have dedicated clauses.
• Investigation procedure and good clinical practice: Clinical trials should follow ISO 14155 (Good Clinical Practice) and established procedures for observer preparation, subject preparation, reference readings and data analysis.
• Disclosure and documentation: The standard requires disclosure of a summary of the clinical investigation in accompanying documents for devices that pass the clinical study.
• Scope limits: ISO 81060-2:2018 does not apply to non‑automated sphygmomanometers (see ISO 81060-1) or to invasive BP monitoring equipment (IEC 60601-2-34).
• Edition notes: This third edition (2018) replaces the 2013 edition and clarifies methods (for example, deletion of the same‑arm simultaneous method and inclusion of kPa equivalents).

Applications - who uses this standard

• Medical device manufacturers developing or validating automated blood‑pressure monitors for markets and regulatory submissions.
• Clinical research organizations and testing laboratories conducting device validation studies.
• Regulatory and quality teams preparing clinical evidence for certification (CE, other jurisdictions).
• Hospitals and clinicians evaluating device performance for clinical use cases (ambulatory monitoring, exercise testing, neonatal/adult modes).
• Procurement and product managers assessing vendor claims on accuracy and intended use.

Related standards

• ISO 81060-1 (non‑automated sphygmomanometers)
• IEC 80601-2-30 (automated non‑invasive sphygmomanometers)
• IEC 60601-2-34 (invasive blood pressure monitoring)
• ISO 14155 (clinical investigation - good clinical practice)
• ISO 14971 (risk management), IEC 60601 series (electrical safety)

Keywords: ISO 81060-2:2018, non‑invasive sphygmomanometers, clinical investigation, automated blood pressure, cuff, auscultatory reference, invasive reference, ambulatory monitoring, home healthcare.