White W B, Berson A S, Robbins C, Jamieson M J, Prisant L M, Roccella E, Sheps S G
Section of Hypertension and Vascular Diseases, University of Connecticut School of Medicine, Farmington 06032-3940.
Hypertension. 1993 Apr;21(4):504-9. doi: 10.1161/01.hyp.21.4.504.
The Association for the Advancement of Medical Instrumentation develops voluntary standards for medical devices so that manufacturers might provide information on their product and basic safety and performance criteria that should be considered in qualifying the instrument for clinical use. American national standards are generated through a consensus process by committees consisting of experts in research, development, and design from user, industry, and government communities. Draft standards are made available for public review and may become American national standards after review by the American National Standards Institute. The first American national standard for electronic and automated sphygmomanometers was published in monograph form in 1987. The objective of the revised 1992 standard for electronic and automated sphygmomanometers is to provide updated labeling, safety, and performance requirements that help ensure that consumers and health care professionals are supplied with safe, accurate devices for the indirect measurement of blood pressure, including ambulatory blood pressure recorders. This standard permits validation of the automatic or electronic device by comparison with either direct, intra-arterial blood pressure measurements or the noninvasive cuff/stethoscope technique, based on Korotkoff sounds identified by individuals trained in auscultation. This summary report of the 1992 American national standard for automatic sphygmomanometers provides recommendations for the methods of comparison, statistical analysis of the data, presentation of the results, and criteria for acceptability. Users, researchers, and instrument designers should refer to the American national standard monograph for detailed requirements.
医疗仪器促进协会制定医疗设备的自愿性标准，以便制造商能够提供有关其产品的信息以及在使仪器符合临床使用标准时应考虑的基本安全和性能标准。美国国家标准是由来自用户、行业和政府团体的研究、开发和设计专家组成的委员会通过协商一致的过程制定的。标准草案可供公众审查，并在美国国家标准学会审查后可能成为美国国家标准。第一部电子和自动血压计的美国国家标准于1987年以专著形式出版。1992年修订的电子和自动血压计标准的目标是提供更新的标签、安全和性能要求，以帮助确保为消费者和医疗保健专业人员提供用于间接测量血压的安全、准确的设备，包括动态血压记录仪。本标准允许通过与直接动脉内血压测量或基于经听诊培训人员识别的柯氏音的无创袖带/听诊器技术进行比较，来验证自动或电子设备。这份1992年美国自动血压计国家标准的总结报告提供了关于比较方法、数据统计分析、结果呈现和可接受标准的建议。用户、研究人员和仪器设计师应参考美国国家标准专著以获取详细要求。
