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ISO 81060-2 Ed.2.0 Edition 04/2013
Non-invasive sphygmomanometers -- Part 2: Clinical investigation of automated measurement type
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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 - Inactive

Origin

Technical Committee :
62D : Electromedical equipment

Implementation

start of the vote on the project      date of ratification (dor)   
end of the vote on the project      date of anouncement (doa)   
start of the vote on the final project      date of publication (dop)   
end of the vote on the final project      date of withdrawal (dow)   


Publication Official Journal
of the Grand-Duchy of Luxembourg
Reference

Relations

Evolutions
IEC 60947-2 Ed. 4.2
IEC 60947-2 Ed. 4.2
IEC 60947-2 Ed. 4.2

International Classification for Standards (ICS codes) :

11.040.10 : Anaesthetic, respiratory and reanimation equipment

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