BS ISO 81060-2:2009 - Non-invasive sphygmomanometers. Clinical validation of automated measurement type – BSI British Standards

BS ISO 81060-2:2009

Non-invasive sphygmomanometers. Clinical validation of automated measurement type

Status : Revised, Superseded, Withdrawn   Published : March 2010 Replaced By : BS EN ISO 81060-2:2014

WITHDRAWN TITLE
*To ask about withdrawn titles contact the
BSI Customer Services
cservices@bsigroup.com, +44 345 086 9001


BS ISO 81060-2:2009 Non-invasive sphygmomanometers. Clinical validation of automated measurement type

BS ISO 81060-2 specifies the requirements and methods for the clinical validation of me equipment used for the intermittent non-invasive automatic estimation of the arterial blood pressure by utilizing a cuff.

BS ISO 81060-2 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.

BS ISO 81060-2 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)

BS ISO 81060-2 specifies additional disclosure requirements for the accompanying documents of sphygmomanometers validated according to this part of ISO 81060.

BS ISO 81060-2 is not applicable to the validation of non-automated sphygmomanometers as given in ISO 81060-1 or invasive blood pressure monitoring equipment as given in IEC 60601-2-34.

Contents of BS ISO 81060-2:

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements for validation studies
4.1 Validation methods
4.2 Ethical requirements
5 Validation with auscultatory reference sphygmomanometer
5.1 Subject requirements
5.2 Validation method with reference sphygmomanometer
6 Validation with reference invasive blood pressure monitoring equipment
6.1 Patient requirements
6.2 Validation methods with reference invasive blood pressure monitoring equipment
7 * Pregnant, including pre-eclamptic, patient populations
Annex A (informative) Rationale
Annex B (normative) Target heart rates for exercise stress testing
Annex C (informative) Reference to the essential principles
Annex D (informative) Terminology — Alphabetized index of defined terms
Bibliography

 




Standard NumberBS ISO 81060-2:2009
TitleNon-invasive sphygmomanometers. Clinical validation of automated measurement type
StatusRevised, Superseded, Withdrawn
Publication Date31 March 2010
Withdrawn Date30 April 2013
Normative References(Required to achieve compliance to this standard)ISO 81060-1:2007, IEC 60601-2-34:2000, IEC 80601-2-30:2009, IEC 60601-1-11, ISO 14155, IEC 60601-1:2005
Informative References(Provided for Information)EN 1060-4, ANSI/AAMI SP10:2002, ANSI/AAMI SP10:1992, ISO/TR 16142:2006, ANSI/AAMI SP10:1987
Replaced ByBS EN ISO 81060-2:2014
International RelationshipsISO 81060-2:2009/Cor 1:2011
Amended ByCorrigendum, September 2011
DescriptorsBlood pressure, Verification, Electrical medical equipment, Clinical investigation instruments, Flow, Pressure measurement (fluids), Clinical testing, Performance, Automatic, Sphygmomanometers, Cuffs, Accuracy, Medical equipment, Medical instruments
ICS11.040.10
11.040.55
Title in FrenchSphygmomanomètres non invasifs. Validation clinique pour type à mesurage automatique
Title in GermanNicht-invasive Blutdruckmessgeräte. Klinische Validierung der automatisierten Bauart
CommitteeCH/121/5
ISBN978 0 580 74196 8
PublisherBSI
FormatA4
DeliveryNo
Pages46
File Size1.347 MB
Price£240.00


WITHDRAWN TITLE
*To ask about withdrawn titles contact the
BSI Customer Services
cservices@bsigroup.com, +44 345 086 9001
 Your basket
Your basket is empty

Multi-user access to over 3,500 medical device standards, regulations, expert commentaries and other documents


Worldwide Standards
We can source any standard from anywhere in the world


Collaborate, Innovate, Accelerate.


Tracked Changes

Understand the changes made to a standard with our new Tracked Changes version