ISO 81060-2:2018 PDF

Non-invasive sphygmomanometers - Part 2: Clinical investigation of intermittent automated measurement type

Open preview (PDF)

Title (English):

ISO 81060-2:2018

Non-invasive sphygmomanometers - Part 2: Clinical investigation of intermittent automated measurement type

Document status:: Active
Format:: Electronic (PDF)
Number of pages:: 36
Publication date:: November 21, 2018
Edition:: IEC IS 81060 edition 3 version 1
ICS:: 11.040.10

Delivery type:

Full version25 €Read online 24h10 €Read online 72h15 €

Document language:

enru

Delivery time:Immediate download

Price:25 €

Description (English):

ISO 81060-2:2018 This document specifies the requirements and methods for the clinical investigation of me equipment used for the intermittent non-invasive automated estimation of the arterial blood pressure by utilizing a cuff. This document is applicable to all sphygmomanometers that sense or display pulsations, flow or sounds for the estimation, display or recording of blood pressure. These sphygmomanometers need not have automatic cuff inflation. This document covers sphygmomanometers intended for use in all patient populations (e.g. all age and weight ranges), and all conditions of use (e.g. ambulatory blood pressure monitoring, stress testing blood pressure monitoring and blood pressure monitors for the home healthcare environment for self-measurement as well as use in a professional healthcare facility). EXAMPLE Automated sphygmomanometer as given in IEC 80601-2-30 undergoing clinical investigation according to this document. This document specifies additional disclosure requirements for the accompanying documents of sphygmomanometers that have passed a clinical investigation according to this document. This document is not applicable to clinical investigations of non-automated sphygmomanometers as given in ISO 81060-1 or invasive blood pressure monitoring equipment as given in IEC 60601-2-34.

Technical details

Technical committee: SC 62D - Particular medical equipment, software, and systems
SKU: ISO 81060-2:2018

Abstract

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.

Related standards

Standards mentioned in the description

Abstract

Overview

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)

ISO 81060-2:2018 PDF

Technical details

Abstract

Overview

Key topics and technical requirements

Applications - who uses this standard

Related standards

Related standards

Abstract

Overview

Key topics and technical requirements

Applications - who uses this standard

Related standards

Related standards

Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2026)

Non-invasive sphygmomanometers - Part 1: Requirements and test methods for non-automated measurement type (IS…

Medical electrical equipment - Part 2-34: Particular requirements for the basic safety and essential performa…

Medical electrical equipment — Part 2-30: Particular requirements for basic safety and essential performance…

Medical devices - Application of risk management to medical devices (ISO 14971:2019)

Medical electrical equipment - Part 2-51: Particular requirements for safety, including essential performance…