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Tsutomu Ichikawa - One of the best experts on this subject based on the ideXlab platform.

  • a universal standard for the validation of blood pressure measuring devices association for the advancement of medical instrumentation european society of hypertension International Organization for standardization aami esh iso collaboration statement
    Journal of Hypertension, 2018
    Co-Authors: George S Stergiou, Bruce S Alpert, Stephan Mieke, Roland Asmar, Neil Atkins, Siegfried Eckert, Gerhard N Frick, Bruce A Friedman, Thomas Grasl, Tsutomu Ichikawa
    Abstract:

    Copyright © 2018 Wolters Kluwer Health, Inc., and American Heart Association, Inc. This article has been copublished in Hypertension. In the last 30 years, several Organizations, such as the US Association for the Advancement of Medical Instrumentation (AAMI), the British Hypertension Society, the European Society of Hypertension (ESH) Working Group on Blood Pressure (BP) Monitoring and the International Organization for Standardization (ISO) have developed protocols for clinical validation of BP measuring devices. However, it is recognized that science, as well as patients, consumers and manufacturers would be best served if all BP measuring devices were assessed for accuracy according to an agreed single validation protocol that had global acceptance. Therefore, an International initiative was taken by AAMI, ESH and ISO experts who agreed to develop a universal standard for device validation. This statement presents the key aspects of a validation procedure, which were agreed by the AAMI, ESH and ISO representatives as the basis for a single universal validation protocol. As soon as the AAMI/ESH/ISO standard is fully developed, this will be regarded as the single universal standard and will replace all other previous standards/protocols.

  • a universal standard for the validation of blood pressure measuring devices association for the advancement of medical instrumentation european society of hypertension International Organization for standardization aami esh iso collaboration statement
    Hypertension, 2018
    Co-Authors: George S Stergiou, Bruce S Alpert, Stephan Mieke, Roland Asmar, Neil Atkins, Siegfried Eckert, Gerhard N Frick, Bruce A Friedman, Thomas Grasl, Tsutomu Ichikawa
    Abstract:

    In the past 30 years, several Organizations, such as the US Association for the Advancement of Medical Instrumentation (AAMI), the British Hypertension Society, the European Society of Hypertension (ESH) Working Group on Blood Pressure (BP) Monitoring, and the International Organization for Standardization (ISO), have developed protocols for clinical validation of BP measuring devices. However, it is recognized that science, as well as patients, consumers, and manufacturers, would be best served if all BP measuring devices were assessed for accuracy according to an agreed single validation protocol that had global acceptance. Therefore, an International initiative was taken by the AAMI, ESH, and ISO experts who agreed to develop a universal standard for device validation. This statement presents the key aspects of a validation procedure, which were agreed by the AAMI, ESH, and ISO representatives as the basis for a single universal validation protocol. As soon as the AAMI/ESH/ISO standard is fully developed, this will be regarded as the single universal standard and will replace all other previous standards/protocols.

  • a universal standard for the validation of blood pressure measuring devices association for the advancement of medical instrumentation european society of hypertension International Organization for standardization aami esh iso collaboration statement
    Hypertension, 2018
    Co-Authors: George S Stergiou, Bruce S Alpert, Stephan Mieke, Roland Asmar, Neil Atkins, Siegfried Eckert, Gerhard N Frick, Bruce A Friedman, Thomas Grasl, Tsutomu Ichikawa
    Abstract:

    In the past 30 years, several Organizations, such as the US Association for the Advancement of Medical Instrumentation (AAMI), the British Hypertension Society, the European Society of Hypertension (ESH) Working Group on Blood Pressure (BP) Monitoring, and the International Organization for Standardization (ISO), have developed protocols for clinical validation of BP measuring devices. However, it is recognized that science, as well as patients, consumers, and manufacturers, would be best served if all BP measuring devices were assessed for accuracy according to an agreed single validation protocol that had global acceptance. Therefore, an International initiative was taken by the AAMI, ESH, and ISO experts who agreed to develop a universal standard for device validation. This statement presents the key aspects of a validation procedure, which were agreed by the AAMI, ESH, and ISO representatives as the basis for a single universal validation protocol. As soon as the AAMI/ESH/ISO standard is fully developed, this will be regarded as the single universal standard and will replace all other previous standards/protocols.

George S Stergiou - One of the best experts on this subject based on the ideXlab platform.

  • validation of the inbody bp170 oscillometric home blood pressure monitor in general population according to the association for the advancement of medical instrumentation european society of hypertension International Organization for standardization universal standard
    Blood Pressure Monitoring, 2020
    Co-Authors: Anastasios Kollias, Ioannis Anagnostopoulos, Areti Gravvani, Emelina Stambolliu, Ioanna Bountzona, Ariadni Menti, George S Stergiou
    Abstract:

    OBJECTIVE: To evaluate the accuracy of the InBody BP170 oscillometric upper-arm home blood pressure (BP) monitor in general population according to the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization (AAMI/ESH/ISO) Universal Standard (ISO 81060-2:2018). METHODS: Subjects were recruited to fulfill the age, gender, BP and cuff distribution criteria of the AAMI/ESH/ISO Universal Standard in general population using the same arm sequential BP measurement method. Two cuffs of the test device were used for arm circumference 22-32 (medium) and 32-42 cm (large). RESULTS: One-hundred five subjects were recruited and 88 were analyzed. For validation Criterion 1, the mean +/- SD of the differences between the test device and reference BP readings was 0.9 +/- 6.9/0.5 +/- 5.5 mmHg (systolic/diastolic). For Criterion 2, the SD of the averaged BP differences between the test device and reference BP per subject was 5.77/4.80 mmHg (systolic/diastolic). CONCLUSION: The InBody BP170 oscillometric home BP monitor fulfilled all the requirements of the AAMI/ESH/ISO Universal Standard (ISO 81060-2:2018) in general population and can be recommended for clinical use.

  • validation of the inbody bpbio250 oscillometric blood pressure monitor for professional office use in general population according to the association for the advancement of medical instrumentation european society of hypertension International Organization for standardization universal standard
    Blood Pressure Monitoring, 2020
    Co-Authors: Anastasios Kollias, Ioannis Anagnostopoulos, Areti Gravvani, Ioanna Bountzona, Ariadni Menti, Konstantinos G Kyriakoulis, George S Stergiou
    Abstract:

    OBJECTIVE The aim of this study was to evaluate the accuracy of the InBody BPBIO250 oscillometric upper-arm professional office blood pressure (BP) monitor in general population according to the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization (AAMI/ESH/ISO) Universal Standard (ISO 81060-2:2018). METHODS Subjects were recruited to fulfil the age, gender, BP, and cuff distribution criteria of the AAMI/ESH/ISO Universal Standard in general population using the same arm sequential BP measurement method. Two cuffs of the test device were used for arm circumference 22-32 (medium) and 32-42 cm (large). RESULTS Ninety-seven subjects were recruited and 88 were analyzed. For validation criterion 1, the mean ± SD of the differences between the test device and reference BP readings was 1.9 ± 5.9/0.9 ± 4.9 mmHg (systolic/diastolic). For criterion 2, the SD of the averaged BP differences between the test device and reference BP per subject was 4.78/4.31 mmHg (systolic/diastolic). CONCLUSION The InBody BPBIO250 professional oscillometric device for office BP measurement fulfilled all the requirements of the AAMI/ESH/ISO Universal Standard (ISO 81060-2:2018) in general population and can be recommended for clinical use.

  • recommendations and practical guidance for performing and reporting validation studies according to the universal standard for the validation of blood pressure measuring devices by the association for the advancement of medical instrumentation european society of hypertension International Organization for standardization aami esh iso
    Journal of Hypertension, 2019
    Co-Authors: George S Stergiou, Roland Asmar, Anastasios Kollias, Paolo Palatini, John P A Ioannidis, Peter S Lacy, Richard J Mcmanus, Martin G Myers, Gianfranco Parati, Andrew Shennan
    Abstract:

    : In the past 30 years, several Organizations have developed protocols for clinical validation of blood pressure measuring devices. An International initiative was recently launched by the US Association for the Advancement of Medical Instrumentation (AAMI), the European Society of Hypertension Working Group on Blood Pressure Monitoring (ESH) and the International Organization for Standardization (ISO), aiming to reach consensus on a universal AAMI/ESH/ISO validation standard. The purpose of this statement by the ESH Working Group on Blood Pressure Monitoring is to provide practical guidance for investigators performing validation studies according to the AAMI/ESH/ISO Universal Standard (ISO 81060-2:2018), to ensure that its stipulations are meticulously implemented and data are fully reported. Thus, this statement provides: a list of key recommendations for validation studies of intermittent non-invasive automated blood pressure measuring devices according to the AAMI/ESH/ISO Universal Standard; practical stepwise guidance for researchers performing these validation studies; a checklist for authors and reviewers of such studies; an example of a complete validation study report.

  • a universal standard for the validation of blood pressure measuring devices association for the advancement of medical instrumentation european society of hypertension International Organization for standardization aami esh iso collaboration statement
    Hypertension, 2018
    Co-Authors: George S Stergiou, Bruce S Alpert, Stephan Mieke, Roland Asmar, Neil Atkins, Siegfried Eckert, Gerhard N Frick, Bruce A Friedman, Thomas Grasl, Tsutomu Ichikawa
    Abstract:

    In the past 30 years, several Organizations, such as the US Association for the Advancement of Medical Instrumentation (AAMI), the British Hypertension Society, the European Society of Hypertension (ESH) Working Group on Blood Pressure (BP) Monitoring, and the International Organization for Standardization (ISO), have developed protocols for clinical validation of BP measuring devices. However, it is recognized that science, as well as patients, consumers, and manufacturers, would be best served if all BP measuring devices were assessed for accuracy according to an agreed single validation protocol that had global acceptance. Therefore, an International initiative was taken by the AAMI, ESH, and ISO experts who agreed to develop a universal standard for device validation. This statement presents the key aspects of a validation procedure, which were agreed by the AAMI, ESH, and ISO representatives as the basis for a single universal validation protocol. As soon as the AAMI/ESH/ISO standard is fully developed, this will be regarded as the single universal standard and will replace all other previous standards/protocols.

  • a universal standard for the validation of blood pressure measuring devices association for the advancement of medical instrumentation european society of hypertension International Organization for standardization aami esh iso collaboration statement
    Journal of Hypertension, 2018
    Co-Authors: George S Stergiou, Bruce S Alpert, Stephan Mieke, Roland Asmar, Neil Atkins, Siegfried Eckert, Gerhard N Frick, Bruce A Friedman, Thomas Grasl, Tsutomu Ichikawa
    Abstract:

    Copyright © 2018 Wolters Kluwer Health, Inc., and American Heart Association, Inc. This article has been copublished in Hypertension. In the last 30 years, several Organizations, such as the US Association for the Advancement of Medical Instrumentation (AAMI), the British Hypertension Society, the European Society of Hypertension (ESH) Working Group on Blood Pressure (BP) Monitoring and the International Organization for Standardization (ISO) have developed protocols for clinical validation of BP measuring devices. However, it is recognized that science, as well as patients, consumers and manufacturers would be best served if all BP measuring devices were assessed for accuracy according to an agreed single validation protocol that had global acceptance. Therefore, an International initiative was taken by AAMI, ESH and ISO experts who agreed to develop a universal standard for device validation. This statement presents the key aspects of a validation procedure, which were agreed by the AAMI, ESH and ISO representatives as the basis for a single universal validation protocol. As soon as the AAMI/ESH/ISO standard is fully developed, this will be regarded as the single universal standard and will replace all other previous standards/protocols.

Roland Asmar - One of the best experts on this subject based on the ideXlab platform.

  • recommendations and practical guidance for performing and reporting validation studies according to the universal standard for the validation of blood pressure measuring devices by the association for the advancement of medical instrumentation european society of hypertension International Organization for standardization aami esh iso
    Journal of Hypertension, 2019
    Co-Authors: George S Stergiou, Roland Asmar, Anastasios Kollias, Paolo Palatini, John P A Ioannidis, Peter S Lacy, Richard J Mcmanus, Martin G Myers, Gianfranco Parati, Andrew Shennan
    Abstract:

    : In the past 30 years, several Organizations have developed protocols for clinical validation of blood pressure measuring devices. An International initiative was recently launched by the US Association for the Advancement of Medical Instrumentation (AAMI), the European Society of Hypertension Working Group on Blood Pressure Monitoring (ESH) and the International Organization for Standardization (ISO), aiming to reach consensus on a universal AAMI/ESH/ISO validation standard. The purpose of this statement by the ESH Working Group on Blood Pressure Monitoring is to provide practical guidance for investigators performing validation studies according to the AAMI/ESH/ISO Universal Standard (ISO 81060-2:2018), to ensure that its stipulations are meticulously implemented and data are fully reported. Thus, this statement provides: a list of key recommendations for validation studies of intermittent non-invasive automated blood pressure measuring devices according to the AAMI/ESH/ISO Universal Standard; practical stepwise guidance for researchers performing these validation studies; a checklist for authors and reviewers of such studies; an example of a complete validation study report.

  • a universal standard for the validation of blood pressure measuring devices association for the advancement of medical instrumentation european society of hypertension International Organization for standardization aami esh iso collaboration statement
    Journal of Hypertension, 2018
    Co-Authors: George S Stergiou, Bruce S Alpert, Stephan Mieke, Roland Asmar, Neil Atkins, Siegfried Eckert, Gerhard N Frick, Bruce A Friedman, Thomas Grasl, Tsutomu Ichikawa
    Abstract:

    Copyright © 2018 Wolters Kluwer Health, Inc., and American Heart Association, Inc. This article has been copublished in Hypertension. In the last 30 years, several Organizations, such as the US Association for the Advancement of Medical Instrumentation (AAMI), the British Hypertension Society, the European Society of Hypertension (ESH) Working Group on Blood Pressure (BP) Monitoring and the International Organization for Standardization (ISO) have developed protocols for clinical validation of BP measuring devices. However, it is recognized that science, as well as patients, consumers and manufacturers would be best served if all BP measuring devices were assessed for accuracy according to an agreed single validation protocol that had global acceptance. Therefore, an International initiative was taken by AAMI, ESH and ISO experts who agreed to develop a universal standard for device validation. This statement presents the key aspects of a validation procedure, which were agreed by the AAMI, ESH and ISO representatives as the basis for a single universal validation protocol. As soon as the AAMI/ESH/ISO standard is fully developed, this will be regarded as the single universal standard and will replace all other previous standards/protocols.

  • a universal standard for the validation of blood pressure measuring devices association for the advancement of medical instrumentation european society of hypertension International Organization for standardization aami esh iso collaboration statement
    Hypertension, 2018
    Co-Authors: George S Stergiou, Bruce S Alpert, Stephan Mieke, Roland Asmar, Neil Atkins, Siegfried Eckert, Gerhard N Frick, Bruce A Friedman, Thomas Grasl, Tsutomu Ichikawa
    Abstract:

    In the past 30 years, several Organizations, such as the US Association for the Advancement of Medical Instrumentation (AAMI), the British Hypertension Society, the European Society of Hypertension (ESH) Working Group on Blood Pressure (BP) Monitoring, and the International Organization for Standardization (ISO), have developed protocols for clinical validation of BP measuring devices. However, it is recognized that science, as well as patients, consumers, and manufacturers, would be best served if all BP measuring devices were assessed for accuracy according to an agreed single validation protocol that had global acceptance. Therefore, an International initiative was taken by the AAMI, ESH, and ISO experts who agreed to develop a universal standard for device validation. This statement presents the key aspects of a validation procedure, which were agreed by the AAMI, ESH, and ISO representatives as the basis for a single universal validation protocol. As soon as the AAMI/ESH/ISO standard is fully developed, this will be regarded as the single universal standard and will replace all other previous standards/protocols.

  • a universal standard for the validation of blood pressure measuring devices association for the advancement of medical instrumentation european society of hypertension International Organization for standardization aami esh iso collaboration statement
    Hypertension, 2018
    Co-Authors: George S Stergiou, Bruce S Alpert, Stephan Mieke, Roland Asmar, Neil Atkins, Siegfried Eckert, Gerhard N Frick, Bruce A Friedman, Thomas Grasl, Tsutomu Ichikawa
    Abstract:

    In the past 30 years, several Organizations, such as the US Association for the Advancement of Medical Instrumentation (AAMI), the British Hypertension Society, the European Society of Hypertension (ESH) Working Group on Blood Pressure (BP) Monitoring, and the International Organization for Standardization (ISO), have developed protocols for clinical validation of BP measuring devices. However, it is recognized that science, as well as patients, consumers, and manufacturers, would be best served if all BP measuring devices were assessed for accuracy according to an agreed single validation protocol that had global acceptance. Therefore, an International initiative was taken by the AAMI, ESH, and ISO experts who agreed to develop a universal standard for device validation. This statement presents the key aspects of a validation procedure, which were agreed by the AAMI, ESH, and ISO representatives as the basis for a single universal validation protocol. As soon as the AAMI/ESH/ISO standard is fully developed, this will be regarded as the single universal standard and will replace all other previous standards/protocols.

Thomas Grasl - One of the best experts on this subject based on the ideXlab platform.

  • a universal standard for the validation of blood pressure measuring devices association for the advancement of medical instrumentation european society of hypertension International Organization for standardization aami esh iso collaboration statement
    Journal of Hypertension, 2018
    Co-Authors: George S Stergiou, Bruce S Alpert, Stephan Mieke, Roland Asmar, Neil Atkins, Siegfried Eckert, Gerhard N Frick, Bruce A Friedman, Thomas Grasl, Tsutomu Ichikawa
    Abstract:

    Copyright © 2018 Wolters Kluwer Health, Inc., and American Heart Association, Inc. This article has been copublished in Hypertension. In the last 30 years, several Organizations, such as the US Association for the Advancement of Medical Instrumentation (AAMI), the British Hypertension Society, the European Society of Hypertension (ESH) Working Group on Blood Pressure (BP) Monitoring and the International Organization for Standardization (ISO) have developed protocols for clinical validation of BP measuring devices. However, it is recognized that science, as well as patients, consumers and manufacturers would be best served if all BP measuring devices were assessed for accuracy according to an agreed single validation protocol that had global acceptance. Therefore, an International initiative was taken by AAMI, ESH and ISO experts who agreed to develop a universal standard for device validation. This statement presents the key aspects of a validation procedure, which were agreed by the AAMI, ESH and ISO representatives as the basis for a single universal validation protocol. As soon as the AAMI/ESH/ISO standard is fully developed, this will be regarded as the single universal standard and will replace all other previous standards/protocols.

  • a universal standard for the validation of blood pressure measuring devices association for the advancement of medical instrumentation european society of hypertension International Organization for standardization aami esh iso collaboration statement
    Hypertension, 2018
    Co-Authors: George S Stergiou, Bruce S Alpert, Stephan Mieke, Roland Asmar, Neil Atkins, Siegfried Eckert, Gerhard N Frick, Bruce A Friedman, Thomas Grasl, Tsutomu Ichikawa
    Abstract:

    In the past 30 years, several Organizations, such as the US Association for the Advancement of Medical Instrumentation (AAMI), the British Hypertension Society, the European Society of Hypertension (ESH) Working Group on Blood Pressure (BP) Monitoring, and the International Organization for Standardization (ISO), have developed protocols for clinical validation of BP measuring devices. However, it is recognized that science, as well as patients, consumers, and manufacturers, would be best served if all BP measuring devices were assessed for accuracy according to an agreed single validation protocol that had global acceptance. Therefore, an International initiative was taken by the AAMI, ESH, and ISO experts who agreed to develop a universal standard for device validation. This statement presents the key aspects of a validation procedure, which were agreed by the AAMI, ESH, and ISO representatives as the basis for a single universal validation protocol. As soon as the AAMI/ESH/ISO standard is fully developed, this will be regarded as the single universal standard and will replace all other previous standards/protocols.

  • a universal standard for the validation of blood pressure measuring devices association for the advancement of medical instrumentation european society of hypertension International Organization for standardization aami esh iso collaboration statement
    Hypertension, 2018
    Co-Authors: George S Stergiou, Bruce S Alpert, Stephan Mieke, Roland Asmar, Neil Atkins, Siegfried Eckert, Gerhard N Frick, Bruce A Friedman, Thomas Grasl, Tsutomu Ichikawa
    Abstract:

    In the past 30 years, several Organizations, such as the US Association for the Advancement of Medical Instrumentation (AAMI), the British Hypertension Society, the European Society of Hypertension (ESH) Working Group on Blood Pressure (BP) Monitoring, and the International Organization for Standardization (ISO), have developed protocols for clinical validation of BP measuring devices. However, it is recognized that science, as well as patients, consumers, and manufacturers, would be best served if all BP measuring devices were assessed for accuracy according to an agreed single validation protocol that had global acceptance. Therefore, an International initiative was taken by the AAMI, ESH, and ISO experts who agreed to develop a universal standard for device validation. This statement presents the key aspects of a validation procedure, which were agreed by the AAMI, ESH, and ISO representatives as the basis for a single universal validation protocol. As soon as the AAMI/ESH/ISO standard is fully developed, this will be regarded as the single universal standard and will replace all other previous standards/protocols.

Bruce A Friedman - One of the best experts on this subject based on the ideXlab platform.

  • a universal standard for the validation of blood pressure measuring devices association for the advancement of medical instrumentation european society of hypertension International Organization for standardization aami esh iso collaboration statement
    Journal of Hypertension, 2018
    Co-Authors: George S Stergiou, Bruce S Alpert, Stephan Mieke, Roland Asmar, Neil Atkins, Siegfried Eckert, Gerhard N Frick, Bruce A Friedman, Thomas Grasl, Tsutomu Ichikawa
    Abstract:

    Copyright © 2018 Wolters Kluwer Health, Inc., and American Heart Association, Inc. This article has been copublished in Hypertension. In the last 30 years, several Organizations, such as the US Association for the Advancement of Medical Instrumentation (AAMI), the British Hypertension Society, the European Society of Hypertension (ESH) Working Group on Blood Pressure (BP) Monitoring and the International Organization for Standardization (ISO) have developed protocols for clinical validation of BP measuring devices. However, it is recognized that science, as well as patients, consumers and manufacturers would be best served if all BP measuring devices were assessed for accuracy according to an agreed single validation protocol that had global acceptance. Therefore, an International initiative was taken by AAMI, ESH and ISO experts who agreed to develop a universal standard for device validation. This statement presents the key aspects of a validation procedure, which were agreed by the AAMI, ESH and ISO representatives as the basis for a single universal validation protocol. As soon as the AAMI/ESH/ISO standard is fully developed, this will be regarded as the single universal standard and will replace all other previous standards/protocols.

  • a universal standard for the validation of blood pressure measuring devices association for the advancement of medical instrumentation european society of hypertension International Organization for standardization aami esh iso collaboration statement
    Hypertension, 2018
    Co-Authors: George S Stergiou, Bruce S Alpert, Stephan Mieke, Roland Asmar, Neil Atkins, Siegfried Eckert, Gerhard N Frick, Bruce A Friedman, Thomas Grasl, Tsutomu Ichikawa
    Abstract:

    In the past 30 years, several Organizations, such as the US Association for the Advancement of Medical Instrumentation (AAMI), the British Hypertension Society, the European Society of Hypertension (ESH) Working Group on Blood Pressure (BP) Monitoring, and the International Organization for Standardization (ISO), have developed protocols for clinical validation of BP measuring devices. However, it is recognized that science, as well as patients, consumers, and manufacturers, would be best served if all BP measuring devices were assessed for accuracy according to an agreed single validation protocol that had global acceptance. Therefore, an International initiative was taken by the AAMI, ESH, and ISO experts who agreed to develop a universal standard for device validation. This statement presents the key aspects of a validation procedure, which were agreed by the AAMI, ESH, and ISO representatives as the basis for a single universal validation protocol. As soon as the AAMI/ESH/ISO standard is fully developed, this will be regarded as the single universal standard and will replace all other previous standards/protocols.

  • a universal standard for the validation of blood pressure measuring devices association for the advancement of medical instrumentation european society of hypertension International Organization for standardization aami esh iso collaboration statement
    Hypertension, 2018
    Co-Authors: George S Stergiou, Bruce S Alpert, Stephan Mieke, Roland Asmar, Neil Atkins, Siegfried Eckert, Gerhard N Frick, Bruce A Friedman, Thomas Grasl, Tsutomu Ichikawa
    Abstract:

    In the past 30 years, several Organizations, such as the US Association for the Advancement of Medical Instrumentation (AAMI), the British Hypertension Society, the European Society of Hypertension (ESH) Working Group on Blood Pressure (BP) Monitoring, and the International Organization for Standardization (ISO), have developed protocols for clinical validation of BP measuring devices. However, it is recognized that science, as well as patients, consumers, and manufacturers, would be best served if all BP measuring devices were assessed for accuracy according to an agreed single validation protocol that had global acceptance. Therefore, an International initiative was taken by the AAMI, ESH, and ISO experts who agreed to develop a universal standard for device validation. This statement presents the key aspects of a validation procedure, which were agreed by the AAMI, ESH, and ISO representatives as the basis for a single universal validation protocol. As soon as the AAMI/ESH/ISO standard is fully developed, this will be regarded as the single universal standard and will replace all other previous standards/protocols.