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自動無創血壓監護儀檢測項目報價???解決方案???檢測周期???樣品要求? |
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本專用標準說明了關于2.102所定義的自動循環無創血壓監護設備的安全性和基本性能的要求。本專用標準此后將簡稱自動循環無創血壓監護設備為設備。設備可以是有人照管的設備,也可以是無人照管的設備。本專用標準不適用于采用手指傳感器的血壓測量設備或每次測量都需要人工啟動的半自動血壓測量設備。
本專用標準適用于在2.101中定義的有創血壓監測和測量設備。 本專用標準不適用于穿刺導管、穿刺針、魯爾(Luer)接頭、活栓和活栓工作臺。 本專用標準也不適用于無創血壓監測設備。
壓力計量名詞術語及定義
本規程適用于示波法、聽診法原理的無創自動測量血壓計[以下簡稱血壓計,包括無創血壓監護儀、多參數監護儀(無創血壓部分)、動態血壓監護儀及電子血壓計]的型式評價、首次檢定、后續檢定和使用中檢驗。
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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