用于验证血压测量设备的通用标准：美国医疗器械促进协会/欧洲高血压学会/国际标准化组织（AAMI/ESH/ISO）合作声明。
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.
机构信息
From the Hypertension Center STRIDE-7, National and Kapodistrian University of Athens, School of Medicine, Third Department of Medicine, Sotiria Hospital, Athens, Greece (G.S.S.); University of Tennessee Health Science Center (B.A.); Physikalisch-Technische Bundesanstalt, Berlin, Germany (S.M.); Foundation, Medical Research Institutes, Paris, France (R.A.); Medaval, Dublin, Ireland (N.A.); Clinic for Cardiology, Herz- und Diabeteszentrum NRW, Ruhr-Universität Bochum, Bad Oeynhausen, Germany (S.E.); Microlife, Switzerland (G.F.); General Electric Healthcare Technologies, USA (B.F.); Dräger, Lübeck, Germany (T.G.); Omron Healthcare, Kyoto, Japan (T.I.); Departments of Medicine and of Health Research and Policy, Stanford University School of Medicine, and Department of Statistics, Stanford University School of Humanities and Sciences, Stanford, USA (J.P.I); Institute of Cardiovascular Science, University College London and the National Institute for Health Research University College London Hospitals Biomedical Research Centre, United Kingdom (P.L.); Nuffield Department of Primary Care Health Sciences, Green Templeton College, University of Oxford, United Kingdom (R.M.); Newcastle University, United Kingdom (A.M.); Schulich Heart Program, Division of Cardiology, Sunnybrook Health Sciences Centre, University of Toronto, Canada (M.M.); Department of Medicine, University of Padova, Italy (P.P.); Department of Medicine and Surgery, University of Milano-Bicocca; Cardiology Unit and Department of Cardiovascular, Neural and Metabolic Sciences, S.Luca Hospital, Istituto Auxologco Italiano, Milano, Italy (G.P.); Welch Allyn, USA (D.Q.); PharmaSmart International, USA (J.S.); St. Thomas' Hospital, King's College London, United Kingdom (A.S.); Nihon Kohden, Tokyo, Japan (T.U.); Shanghai Institute of Hypertension, Department of Hypertension, Centre for Epidemiological Studies and Clinical Trials, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, China (J.W.); Office of Biostatistics Research, National Heart, Lung and Blood Institute, National Institutes of Health, Bethesda, MD (C.O.W.); and The Conway Institute, University College Dublin, Ireland (E.O.B.).
出版信息
Hypertension. 2018 Mar;71(3):368-374. doi: 10.1161/HYPERTENSIONAHA.117.10237. Epub 2018 Jan 31.
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.
在过去的 30 年里，一些组织，如美国医疗器械促进协会（AAMI）、英国高血压学会、欧洲高血压学会（ESH）血压监测工作组以及国际标准化组织（ISO），已经制定了用于临床验证血压测量设备的方案。然而，如果所有的血压测量设备都能够根据一个被全球认可的通用验证方案来评估准确性，那么科学界、患者、消费者和制造商将得到最大的受益。因此，AAMI、ESH 和 ISO 的专家们采取了一项国际举措，他们同意制定一个设备验证的通用标准。本声明提出了验证程序的关键方面，这些方面得到了 AAMI、ESH 和 ISO 代表的认可，作为单一通用验证方案的基础。一旦 AAMI/ESH/ISO 标准完全制定完成，它将被视为单一通用标准，并取代所有其他先前的标准/方案。
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