Clinical Validation Protocols for Blood Pressure Monitors
ISO CEN BSI AAMI ANSI
81060-3:2022
ISO/TC 121/SC 3. ISO 81060-3:2022, Non-invasive sphygmomanometers — Part 3: Clinical investigation of continuous automated measurement type. Geneva, Switzerland: ISO; 2022 Sep 20. Information here.
81060-2:2020
ISO/TC 121/SC 3. ISO 81060-2:2018/Amd 1:2020, Non-invasive sphygmomanometers — Part 2: Clinical investigation of intermittent automated measurement type — AMENDMENT 1. Geneva, Switzerland: ISO; 2020 Jan 08. Information here.
81060-2:2018
ISO/TC 121/SC 3. ISO 81060-2:2018, Non-invasive Sphygmomanometers – Part 2: Clinical Investigation of Automated Measurement Type. Geneva, Switzerland: ISO; 2018 Nov 23. Information here.
idem quod
Association for the Advancement of Medical Instrumentation, American National Standards Institute, International Organization for Standardization. AAMI/ANSI/ISO 81060-2:2019, Non-invasive Sphygmomanometers – Part 2: Clinical Investigation of Automated Measurement Type. Arlington, VA, USA: AAMI; 2019 Aug 20. Information here.
idem quod
British Standards, European Norme, International Organization for Standardization. BS EN ISO 81060-2:2019, Non-invasive Sphygmomanometers – Part 2: Clinical Investigation of Automated Measurement Type. Brussels, Belgium: CEN; 2019 Dec 9. Information here.
AAMI/ANSI/ISO
81060-1:2013
Association for the Advancement of Medical Instrumentation, American National Standards Institute, International Organization for Standardization. AAMI/ANSI/ISO 81060-1:2007/(R)2013, Non-Invasive Sphygmomanometers – Part 1: Requirements and Test Methods for Non-Automated Measurement Type. Arlington, VA, USA: AAMI; 2013. Preview available here.
IEEE
1708:2014
IEEE Engineering in Medicine and Biology Society. 1708-2014 – IEEE Standard for Wearable Cuffless Blood Pressure Measuring Devices. Piscataway, New Jersey, USA: IEEE; 2014. Available here.
JIS
JIS T 1115:2018
日本工業標準調査会 [Japan Industrial Standards Research Committee]. JIS T 1115:2018: 日本工業規格 – 非観血式電子血圧計 [Japan Industrial Standards – Non-invasive Automated Sphygmomanometers]. Tokyo: 日本規格協会 [Japan Standards Association];2018. Available here.
ESH
ESH-IP:2010
O’Brien E, Atkins N, Stergiou G, Karpettas N, Parati G, Asmar R, Imai Y, Wang J, Mengden T, Shennan A; 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. doi: 10.1097/MBP.0b013e3283360e98. PMID: 20110786. Erratum in Blood Press Monit. 2010;15(3):171-2.
ESH-IP:2002
O’Brien E, Pickering T, Asmar R, Myers M, Parati G, Staessen J, Mengden T, Imai Y, Waeber B, Palatini P, Atkins N, Gerin W; Working Group on Blood Pressure Monitoring of the European Society of Hypertension. Working Group on Blood Pressure Monitoring of the European Society of Hypertension International protocol for validation of blood pressure measuring devices in adults. Blood Press Monit. 2002;7(1):3-17. PMID: 12040236.
BHS
BHS:1993
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. Download here.
BHS:1990
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(7):607-19. PMID: 2168451.
AAMI/ANSI/ISO and DIN/EN
81060-2:2013
Association for the Advancement of Medical Instrumentation, American National Standards Institute, International Organization for Standardization. AAMI/ANSI/ISO 81060-2:2013, Non-invasive Sphygmomanometers – Part 2: Clinical Investigation of Automated Measurement Type. Arlington, VA, USA: AAMI; 2013.
idem quod
Deutsches Institut für Normung. DIN EN ISO 81060-2:2014-10: Nichtinvasive Blutdruckmessgeräte – Teil 2: Klinische Prüfung der automatisierten Bauart (ISO 81060-2:2013); Deutsche Fassung EN ISO 81060-2:2014. Berlin, Deutschland: DIN; 2014.
81060-2:2009
Association for the Advancement of Medical Instrumentation, American National Standards Institute, International Organization for Standardization. AAMI/ANSI/ISO 81060-2:2009, Non-invasive Sphygmomanometers – Part 2: Clinical Investigation of Automated Measurement Type. Arlington, VA, USA: AAMI; 2009.
81060-1:2007
Association for the Advancement of Medical Instrumentation, American National Standards Institute, International Organization for Standardization. AAMI/ANSI/ISO 81060-1:2007, Non-Invasive Sphygmomanometers – Part 1: Requirements and Test Methods for Non-Automated Measurement Type. Arlington, VA, USA: AAMI; 2008.
idem quod
Deutsches Institut für Normung, DIN EN ISO 81060-1:2012-08: Nicht invasive Blutdruckmessgeräte – Teil 1: Anforderungen und Prüfverfahren der nicht-automatisierten Bauart (ISO 81060-1:2007); Deutsche Fassung EN ISO 81060-1:2012. Berlin, Deutschland: DIN; 2012.
SP10:2006
American National Standards Institute, Association for the Advancement of Medical Instrumentation. ANSI/AAMI SP10:2002/A2:2006, Manual, electronic or automated sphygmomanometers. Arlington, VA, USA: AAMI; 2006.
SP10:2003
American National Standards Institute, Association for the Advancement of Medical Instrumentation. ANSI/AAMI SP10:2002/A1:2003, Manual, electronic or automated sphygmomanometers. Arlington, VA, USA: AAMI; 2003.
SP10:2002
American National Standards Institute, Association for the Advancement of Medical Instrumentation. ANSI/AAMI SP10:2002, Manual, electronic or automated sphygmomanometers. Arlington, VA, USA: AAMI; 2003.
SP10:1996
American National Standards Institute, ANSI/AAMI SP10:1992/A1:1996, Association for the Advancement of Medical Instrumentation. American National Standard. Electronic or automated sphygmomanometers. Arlington, VA, USA: AAMI; 1996.
SP10:1992
American National Standards Institute, Association for the Advancement of Medical Instrumentation. ANSI/AAMI SP10:1992, Electronic or automated sphygmomanometers. Arlington, VA, USA: AAMI; 1993.
SP10:1987
American National Standards Institute, Association for the Advancement of Medical Instrumentation. ANSI/AAMI SP10:1987, Electronic or automated sphygmomanometers. Arlington, VA, USA: AAMI; 1987.
EN
1060-3:2009
CEN Technical Committee 205. EN 1060-3:1997+A2:2009: Non-invasive sphygmomanometers – Part 3: Supplementary requirements for electro-mechanical blood pressure measuring systems. Brussels, Belgium: CEN; 2009. CEN information here.
1060-4:2004
CEN Technical Committee 205. EN 1060-4:2004: Non-invasive sphygmomanometers – Part 4: Test procedures to determine the overall system accuracy of automated non-invasive sphygmomanometers. Brussels, Belgium: CEN; 2004. CEN information here.
idem quod
Deutsches Institut für Normung. DIN EN 1060-4:2004-12: Nichtinvasive Blutdruckmessgeräte – Teil 4: Prüfverfahren zur Bestimmung der Messgenauigkeit von automatischen nichtinvasiven Blutdruckmessgeräten; Deutsche Fassung EN 1060-4:2004. Berlin, Deutschland: DIN; 2004.
DIN
58130:1996
Deutsches Institut für Normung. DIN 58130:1996-12: Nichtinvasive Blutdruckmeßgeräte – Klinische Prüfung [Non-invasive sphygmomanometers – Clinical investigation]. Berlin, Deutschland: DIN; 1996.
58130:1995
Deutsches Institut für Normung. DIN 58130:1995-01: Nichtinvasive Blutdruckmeßgeräte – Klinische Prüfung [Non-invasive sphygmomanometers – Clinical investigation]. Berlin, Deutschland: DIN; 1995.
DHL
DHL:2016
Deutsche Hochdruckliga e.V. DHL® Deutsche Gesellschaft für Hypertonie und Prävention [German Hypertension League e.V. DHL® German Society for Hypertension and Prevention]. Klinische Prüfung von Blutdruckmessgeräten zur Erlangung eines Prüfsiegels (Prüfsiegel DHL®: 2016-10). [Clinical testing of blood pressure monitors for obtaining a Quality Seal (Quality Seal DHL®: 2016-10).] Heidelberg: DHL; 2016. Download here.
DHL:2007
Deutsche Hochdruckliga (DHL) [German Hypertension League]. Klinische Prüfung von Blutdruckmessgeräten zur Erlangung eines Prüfsiegels der Deutschen Liga Hochdruckliga. [Clinical testing of blood pressure monitors for obtaining a German Hypertension League Quality Seal.] Heidelberg: DHL; 1999/A1:2007.
DHL:1999
Deutsche Hochdruckliga (DHL) [German Hypertension League]. Klinische Prüfung von Blutdruckmessgeräten zur Erlangung eines Prüfsiegels der Deutschen Liga Hochdruckliga. [Clinical testing of blood pressure monitors for obtaining a German Hypertension League Quality Seal.] Heidelberg: DHL; 1999.
JIS
JIS T 1115:2005
日本工業標準調査会 [Japan Industrial Standards Research Committee]. JIS T 1115:2005: 日本工業規格 – 非観血式電子血圧計 [Japan Industrial Standards – Non-invasive Automated Sphygmomanometers]. Tokyo: 日本規格協会 [Japan Standards Association];2005. Available here.
JIS T 1115:1987
Technical Committee on Medical Equipment. JIS T 1115:1987: 日本工業規格 -非侵害的电子血压计[Japan Industrial Standards – Non-invasive Electronic Sphygmomanometers]. Tokyo: 日本規格協会 [Japan Standards Association];1987 Feb 15.