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自動無創(chuàng)血壓監(jiān)護(hù)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(biāo)準(zhǔn)說明了關(guān)于2.102所定義的自動循環(huán)無創(chuàng)血壓監(jiān)護(hù)設(shè)備的安全性和基本性能的要求。本專用標(biāo)準(zhǔn)此后將簡稱自動循環(huán)無創(chuàng)血壓監(jiān)護(hù)設(shè)備為設(shè)備。設(shè)備可以是有人照管的設(shè)備,也可以是無人照管的設(shè)備。本專用標(biāo)準(zhǔn)不適用于采用手指傳感器的血壓測量設(shè)備或每次測量都需要人工啟動的半自動血壓測量設(shè)備。
本專用標(biāo)準(zhǔn)適用于在2.101中定義的有創(chuàng)血壓監(jiān)測和測量設(shè)備。 本專用標(biāo)準(zhǔn)不適用于穿刺導(dǎo)管、穿刺針、魯爾(Luer)接頭、活栓和活栓工作臺。 本專用標(biāo)準(zhǔn)也不適用于無創(chuàng)血壓監(jiān)測設(shè)備。
壓力計量名詞術(shù)語及定義
本規(guī)程適用于示波法、聽診法原理的無創(chuàng)自動測量血壓計[以下簡稱血壓計,包括無創(chuàng)血壓監(jiān)護(hù)儀、多參數(shù)監(jiān)護(hù)儀(無創(chuàng)血壓部分)、動態(tài)血壓監(jiān)護(hù)儀及電子血壓計]的型式評價、首次檢定、后續(xù)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.