Validation Protocols |
International Protocol of the European Society of Hypertension |
| O’Brien E, Atkins N, Stergiou G, Karpettas N, Parati G, Asmar R, Imai Y, Wang J, Mengden T, Shennan A; on behalf of the Working Group on Blood Pressure Monitoring of the European Society of Hypertension. European Society of Hypertension International Protocol revision 2010 for the Validation of Blood Pressure Measuring Devices In Adults. Blood Press Monit 2010;15:23–38. |
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O'Brien E, Pickering T, Asmar R,
Myers M, Parati G, Staessen J, Mengden T, Imai Y, Waeber B,
Palatini P with the statistical assistance of Atkins N and Gerin
W on behalf of the Working Group on Blood Pressure Monitoring
of the European Society of Hypertension.
International
protocol for validation of blood pressure measuring devices
in adults
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Blood Press Monit 2002;7:3-17
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British Hypertension Society |
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O'Brien E, Petrie J, Littler WA, de Swiet M, Padfield
PL, Altman D, Bland M, Coats A, Atkins N.� The British Hypertension
Society Protocol for the evaluation of blood pressure measuring
devices.� J Hypertens 1993;11(suppl 2):S43-S63.
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O'Brien E, Petrie J, Littler WA, de Swiet M, Padfield
PL, Altman D, Bland M, Coats A, Atkins N.� Short report. An
outline of the British Hypertension Society Protocol for the
evaluation of blood pressure measuring devices.� J Hypertens
1993;11:677-679.
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O'Brien E, Petrie J, Littler W, de Swiet M, Padfield
PL, O'Malley K, Jamieson M, Altman D, Bland M, Atkins N.� The
British Hypertension Society Protocol for the evaluation of
automated and semi-automated blood pressure measuring devices
with special reference to ambulatory systems.� J Hypertens
1990;8:607-619.
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O'Brien E, Petrie J, Littler W, De Swiet M, Padfield
P, O'Malley K, Jamieson MJ, Altman� D, Bland M, Atkins N.� The
Britisih Hypertension Society protocol for the evaluation of
automated and semi-automated blood pressure measuring devices
with special reference to ambulatory systems.�
J Ambulatory
Monitoring
1991;4:207-228.
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O'Brien E, Petrie J, Littler W, de Swiet M, Padfield
PL, O'Malley K, Jamieson M, Altman D, Bland M, Atkins N.� The
British Hypertension Society Protocol for the evaluation of
automated and semi-automated blood pressure measuring devices
with special reference to ambulatory systems.� In
Blood Pressure
Measurement.
Eds. E. O'Brien and K. O'Malley.�� HANDBOOK
OF HYPERTENSION. Eds.� W.H.Birkenhager and J.L.Reid.� Elsevier.
Amsterdam. 1991. pp.� 430-451
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Association for the Advancement of Medical Instrumentation (America) |
| Association for the Advancement of Medical Instrumentation. American National Standard. ANSI/AAMI/ISO 81060-2:2013 Non-invasive sphygmomanometers - Part 2: Clinical investigation of automated measurement type. 4301 N. Fairfax Drive, Suite 301, Arlington, VA 22203-1633, USA: AAMI; 2013. |
| Association for the Advancement of Medical Instrumentation. American National Standard. Manual, electronic or automated sphygmomanometers ANSI/AAMI SP10-2002/A1. 3330 Washington Boulevard, Suite 400, Arlington, VA 22201-4598, USA: AAMI; 2003. |
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| Association for the Advancement of Medical Instrumentation. American National Standard. Manual, electronic or automated sphygmomanometers ANSI/AAMI SP10-2002. 3330 Washington Boulevard, Suite 400, Arlington, VA 22201-4598, USA: AAMI; 2003. |
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| Association for the Advancement of Medical Instrumentation. American National Standard. Electronic or automated sphygmomanometers ANSI/AAMI SP10-1992/A1. 3330 Washington Boulevard, Suite 400, Arlington, VA 22201-4598, USA: AAMI; 1996. |
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| Association for the Advancement of Medical Instrumentation. American National Standard. Electronic or automated sphygmomanometers ANSI/AAMI SP10-1992. 3330 Washington Boulevard, Suite 400, Arlington, VA 22201-4598, USA: AAMI; 1993. |
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| Association for the Advancement of Medical Instrumentation. American National Standard. Electronic or automated sphygmomanometers ANSI/AAMI SP10-1987. 3330 Washington Boulevard, Suite 400, Arlington, VA 22201-4598, USA: AAMI; 1987. |
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Other Protocols |
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Normenausschuß Feinmechanik und Optik (NaFuO)
im DIN Deutsches Institut f�r Normierung e V: Non-invasive sphygmomanometers
- Clinical Investigation. Berlin: Beuth Verlag; 1996
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Commentary on Protocols
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O'Brien E, Atkins N. A comparison of the BHS and
AAMI protocols for validating blood pressure measuring devices:�
can the two be reconciled?� J Hypertension 1994; 12:1089-1094
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O'Brien E. Towards improving procedures for validating
blood pressure measuring devices.
Blood Pressure Monitoring
1997;2:247-249
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O'Brien E. Criteria for validation of devices.
Task Force I: Methodological aspects.
Blood Pressure Monit
1999;4:279-281
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O'Brien E. Methods of analysis. Task Force I:
Methodological aspects. Blood Pressure Monit 1999;4:286-287
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O'Brien E. Modification of blood-pressure measuring
devices and the protocol of the British Hypertension Society.
Blood Pressure Monit 1999;4:53-54
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O'Brien E. Validation Up-date.
Blood Press
Monit
2001;6:275-280
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O'Brien E and Atkins N on behalf
of the Working Group of the Working Group on Blood Pressure
Monitoring of the European Society of Hypertension. The "International
Protocol": More Insight or More Arithmetic?
J Blood Pressure
Monit
2002;5:290-291
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Methodology of Validation Protocols
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Atkins N, O'Brien E, Mee F, O'Malley K.� The relative
accuracy of simultaneous same arm, simultaneous opposite arm
and sequential same arm measurements in the validation of automated
blood pressure measuring devices. �J Human Hypertens
1990;4:647-649.
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O'Brien E, Mee F, Atkins N, O'Malley K, Tan S.�
Training and assessment of observers for blood pressure measurement
in hypertension research.� J Human Hypertension� 1991;5:7-10
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O'Brien E, Atkins N, Mee F, Coyle D, Syed S. A
new audio-visual technique for recording blood pressure in research:�
the Sphygmocorder. J Hypertens 1995;13:1734-1737.
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Atkins N, O'Brien E, Wesseling KH, Guelen I. Increasing
observer objectivity with audio-visual technology: the Sphygmocorder.
Blood Pressure Monitoring
1997;2:269-272
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Sphygmomanometer Standards
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| Turner a MJ , Irwig b L , Alexandra J. Bune c AJ , Kam a PC, Baker a AB. Lack of sphygmomanometer calibration causes over- and under-detection of hypertension: a computer simulation study J Hypertens 2006;24:1931-1938 |
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| Parati a G , Faini a A, Castiglioni c P. Accuracy of blood pressure measurement: sphygmomanometer calibration and beyond J Hypertens 2006;24:1915-1918 |
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O'Brien E, Petrie JC, Littler WA, deSwiet M.�
Standards for Blood Pressure Measuring Devices.
Br Med J
1987;244:1245-1246.
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Specification for Aneroid and Mercury non-automated
sphygmomanometers. BS 2743:1990.� British Standards Institiution.
London 1990.
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CMS. Centers for Medicare & Medicaid Services.
Medicare Coverage Policy ~ Decisions. ABPM Monitoring (#CAG-00067N).
2001.
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European Standard EN 1060-1 (British Standard
BSSEN 1060-1:1996). Specification for Non-invasive sphygmomanometers.
Part I. General requirements. 1995. European Commission for
Standardisation. Rue Stassart 36, B-1050 Brussels.
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European Standard EN 1060-2 (British Standard
BSSEN 1060-2:1996). Specification for Non-invasive sphygmomanometers.
Part 2. Supplementary requirements for mechanical sphygmomanometers.
1995. European Commission for Standardisation. Rue Stassart
36, B-1050 Brussels.
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Non-invasive sphygmomanometers. Part 3. Supplementary
requirements for electro-mechanical blood pressure measuring
systems. British Standard BS EN 1060-3: 1997. European Standard
EN 1060-3 1997. European Committee for Standardization. Central
Secretariat: rue de Stassart 36, B-1050, Brussels.
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Simulators |
| John N, Amoore JN, Lemesre Y, Murray IC, Mieke S, King ST, Smith FE, Murray A. Automatic blood pressure measurement: the oscillometric waveform shape is a potential contributor to differences between oscillometric and auscultatory pressure measurements Journal of Hypertension 2008;26:35–43 |
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| Amoore JN, Vacher E, Murray IC, Mieke S, King ST, Smith FE, Murray A. Can a simulator that regenerates physiological waveforms evaluate oscillometric non-invasive blood pressure devices? Blood Pressure Monitoring 2006;11:63-67 |
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Davis
P D, Dennis J L and Railton R.
Evaluation
of the A&D UA-767 and Welch Allyn Spot Vital Signs noninvasive
blood pressure monitors using a blood pressure simulator.
Journal
of Human Hypertension
2005;3:197-203
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Device Equivalence |
| Atkins N, O'Brien E. The dabl Educational Trust Device Equivalence Procedure Blood Pressure Monitoring 2007;12:245-249 |
