Prisant L M, Alpert B S, Robbins C B, Berson A S, Hayes M, Cohen M L, Sheps S G
Department of Medicine, Medical College of Georgia, Augusta, USA.
Am J Hypertens. 1995 Feb;8(2):210-3. doi: 10.1016/0895-7061(94)00175-B.
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 of experts in research, development, and design from user, industry, and government communities. Draft standards are made available for public review and become American National Standards after review by the American National Standards Institute. This report is a summary of the American National Standard that establishes both the safety and performance requirements of pneumatic and other nonautomated sphygmomanometers (especially mercury gravity and aneroid sphygmomanometers) used in the indirect measurement of blood pressure. This standard was developed by a consensus panel from academia, industry, and government; it updates the previous standard approved by the American National Standards Institute in 1986. This summary report does not cover all of the provisions of the revised 1994 American National Standard, thus users, researchers, and instrument designers should refer to the standard for detailed requirements.
医疗仪器促进协会制定了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成为美国国家标准。本报告是美国国家标准的摘要，该标准规定了用于间接测量血压的气动和其他非自动血压计（特别是汞柱式和无液血压计）的安全和性能要求。本标准由来自学术界、行业和政府的协商一致小组制定；它更新了美国国家标准学会1986年批准的先前标准。本摘要报告并未涵盖1994年修订的美国国家标准的所有条款，因此用户、研究人员和仪器设计师应参考该标准以获取详细要求。
