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FprEN ISO 81060-2 Edition 03/2013
Non-invasive sphygmomanometers - Part 2: Clinical validation of automated measurement type (ISO 81060-2:2009 + Cor 1:2011)
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Abstract

ISO 81060-2:2009 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 81060-2:2009 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 or self-measurement). ISO 81060-2:2009 specifies additional disclosure requirements for the accompanying documents of sphygmomanometers validated according to this International Standard.

Status

Final draft - Withdrawn

Origin

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

Directives

93/42/EEC : Medical devices

Implementation

start of the vote on the project      date of ratification (dor)    07/01/2013
end of the vote on the project      date of anouncement (doa)    07/06/2013
start of the vote on the final project      date of publication (dop)    09/09/2013
end of the vote on the final project      date of withdrawal (dow)    09/09/2013


Publication Official Journal
of the Grand-Duchy of Luxembourg
Reference

Relations

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

International Classification for Standards (ICS codes) :

11.040.10 : Anaesthetic, respiratory and reanimation equipment

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