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  • BSI
    BS EN ISO 81060-2:2019+A1:2020 Non-invasive sphygmomanometers - Clinical investigation of intermittent automated measurement type
    Edition: 2020
    $473.45
    / user per year

Description of BS EN ISO 81060-2:2019+A1:2020 2020

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.



Standard NumberBS EN ISO 81060-2:2019+A1:2020
TitleNon-invasive sphygmomanometers - Clinical investigation of intermittent automated measurement type
StatusWithdrawn
Publication Date2020-09-18
Withdrawn Date2024-04-04
ReplacesBS EN ISO 81060-2:2014
Identical National Standard OfEN ISO 81060-2:2018/Amd 1, ISO 81060-2:2018/Amd 1
AmendsBS EN ISO 81060-2:2019
DescriptorsBlood pressure, Performance, Sphygmomanometers, Flow, Clinical testing, Verification, Automatic, Accuracy, Clinical investigation instruments, Electrical medical equipment, Medical instruments, Pressure measurement (fluids), Medical equipment, Cuffs
ICS11.040.55 Diagnostic equipment, 11.040.10 Anaesthetic, respiratory and reanimation equipment
CommitteeCH/205/10
ISBN978 0 539 04404 1
PublisherBSI
Pages48

About BSI

BSI Group, also known as the British Standards Institution is the national standards body of the United Kingdom. BSI produces technical standards on a wide range of products and services and also supplies certification and standards-related services to businesses.
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