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ILNAS-EN ISO 81060-2:2014 Edition 04/2014
Non-invasive sphygmomanometers - Part 2: Clinical investigation of automated measurement type (ISO 81060-2:2013)
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Abstract

ISO 81060-2:2013 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. ISO 81060-2:2013 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. ISO 81060-2:2013 covers sphygmomanometers intended for use in all patient populations and all conditions of use. ISO 81060-2:2013 specifies additional disclosure requirements for the accompanying documents of sphygmomanometers that have undergone clinical investigation according to ISO 81060-2:2013.

Status

Standard - Withdrawn

Origin

Technical Committee :
CEN/TC 205 : Non-active medical devices

Implementation

start of the vote on the project      date of ratification (dor)    18/04/2014
end of the vote on the project      date of anouncement (doa)    31/07/2014
start of the vote on the final project    17/10/2013   date of publication (dop)    31/10/2014
end of the vote on the final project    17/03/2014   date of withdrawal (dow)    30/04/2017


Publication Official Journal
of the Grand-Duchy of Luxembourg
07/11/2014
Reference Mémorial A N° 206

Relations

Evolutions
ILNAS-EN ISO 81060-2:2019

Relations to older standards
ILNAS-EN 1060-4:2004

International Classification for Standards (ICS codes) :

11.040.55 : Diagnostic equipment

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