Hypertension Center STRIDE-7, National and Kapodistrian University of Athens, School of Medicine, Third Department of Medicine, Sotiria Hospital, Athens, Greece.
University of Tennessee Health Science Center, USA (retired).
J Hypertens. 2018 Mar;36(3):472-478. doi: 10.1097/HJH.0000000000001634.
: 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.
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）血压监测工作组和国际标准化组织（ISO），已经制定了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根据一个被全球认可的、达成一致的单一验证方案来评估准确性，那么科学、患者、消费者和制造商将得到最好的服务。因此，AAMI、ESH 和 ISO 的专家们采取了一项国际倡议，他们同意制定一个设备验证的通用标准。本声明介绍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，并将取代所有其他以前的标准/方案。
