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自动无创血压监护仪检测项目报价? 解决方案? 检测周期? 样品要求? |
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本专用标准说明了关于2.102所定义的自动循环无创血压监护设备的安全性和基本性能的要求。本专用标准此后将简称自动循环无创血压监护设备为设备。设备可以是有人照管的设备,也可以是无人照管的设备。本专用标准不适用于采用手指传感器的血压测量设备或每次测量都需要人工启动的半自动血压测量设备。
本专用标准适用于在2.101中定义的有创血压监测和测量设备。 本专用标准不适用于穿刺导管、穿刺针、鲁尔(Luer)接头、活栓和活栓工作台。 本专用标准也不适用于无创血压监测设备。
压力计量名词术语及定义
本规程适用于示波法、听诊法原理的无创自动测量血压计[以下简称血压计,包括无创血压监护仪、多参数监护仪(无创血压部分)、动态血压监护仪及电子血压计]的型式评价、首次检定、后续检定和使用中检验。
IMPORTANT NOTICE: This standard is not intended to ensure safety, security, health, orenvironmental protection in all circumstances. Implementers of the standard are responsible fordetermining appropriate safety, security, environmental, and health practices or regulatoryrequirements.This IEEE document is made available for use subject to important notices and legal disclaimers. Thesenotices and disclaimers appear in all publications containing this document and may be found under theheading “Important Notice” or “Important Notices and Disclaimers Concerning IEEE Documents.”They can also be obtained on request from IEEE or viewed at http://standards.ieee.org/IPR/disclaimers.html.Within the context of the ISO/IEEE 11073 family of standards for device communication, this standardestablishes a normative definition of communication between personal telehealth blood pressure monitordevices and compute engines (e.g., cell phones, personal computers, personal health appliances, and set topboxes) in a manner that enables plug-and-play interoperability. It leverages appropriate portions of existingstandards including ISO/IEEE 11073 terminology, information models, application profile standards, andtransport standards. It specifies the use of specific term codes, formats, and behaviors in telehealthenvironments restricting optionality in base frameworks in favor of interoperability. This standard defines acommon core of communication functionality for personal telehealth blood pressure monitors.
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