BS EN ISO 81060-2:2014 - Non-invasive sphygmomanometers. Clinical investigation of automated measurement type

BS EN ISO 81060-2:2014

Non-invasive sphygmomanometers. Clinical investigation of automated measurement type

Status : Superseded, Withdrawn   Published : April 2013 Replaced By : BS EN ISO 81060-2:2019+A1:2020

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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.




Standard NumberBS EN ISO 81060-2:2014
TitleNon-invasive sphygmomanometers. Clinical investigation of automated measurement type
StatusSuperseded, Withdrawn
Publication Date30 April 2013
Withdrawn Date09 December 2019
Normative References(Required to achieve compliance to this standard)ISO 81060-1, IEC 60601-1-11:2010, IEC 60601-1:2005, IEC 60601-2-34:2011, IEC 80601-2-30:2009, ISO 14155:2011
Informative References(Provided for Information)ANSI/AAMI SP10:2002, ANSI/AAMI SP10:1987, ANSI/AAMI SP10:1992, 93/42/EEC, EN 1060-4, ISO/TR 16142:2006
Replaced ByBS EN ISO 81060-2:2019+A1:2020
ReplacesBS ISO 81060-2:2009
International RelationshipsEN ISO 81060-2:2014,ISO 81060-2:2013
Amended ByCorrigendum, June 2014
DescriptorsMedical instruments, Electrical medical equipment, Medical equipment, Accuracy, Clinical investigation instruments, Pressure measurement (fluids), Performance, Clinical testing, Sphygmomanometers, Cuffs, Blood pressure, Flow, Verification, Automatic
ICS11.040.10
11.040.55
Title in FrenchSphygmomanomètres non invasifs. Validation clinique pour type à mesurage automatique
Title in GermanNichtinvasive Blutdruckmessgeräte. Klinische Prüfung von Geräten der automatisierten Bauart
CommitteeCH/205
ISBN978 0 580 83804 0
PublisherBSI
FormatA4
DeliveryYes
Pages52
File Size2.165 MB
Price£260.00


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