多功能病人監(jiān)護(hù)設(shè)備檢測(cè)

多功能病人監(jiān)護(hù)設(shè)備檢測(cè)項(xiàng)目報(bào)價(jià)？??解決方案？??檢測(cè)周期？??樣品要求？

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GB 9706.8-2009醫(yī)用電氣設(shè)備　第2-4部分:心臟除顫器安全專(zhuān)用要求

本專(zhuān)用標(biāo)準(zhǔn)規(guī)定了在2.1.101中定義的心臟除顫器的安全要求，本文此后稱(chēng)心臟除顫器為設(shè)備。本專(zhuān)用標(biāo)準(zhǔn)不適用于植入式除顫器、遙控除顫器、體外經(jīng)皮起搏器、分開(kāi)單立的心臟監(jiān)護(hù)儀(符合GB 9706.25)。使用分開(kāi)的心電監(jiān)護(hù)電極的心臟監(jiān)護(hù)儀不在本標(biāo)準(zhǔn)適用范圍內(nèi)，除非其被作為自動(dòng)體外除顫器(AED)心律識(shí)別檢測(cè)或同步心電復(fù)律的心搏檢測(cè)的唯一基準(zhǔn)使用。

YY 0784-2010醫(yī)用電氣設(shè)備 醫(yī)用脈搏血氧儀設(shè)備基本安全和主要性能專(zhuān)用要求

引用GB 9706.1-2007的第1章,不包括以下內(nèi)容。 修改(增加在1.1末尾處) 本標(biāo)準(zhǔn)詳細(xì)描述了適用于人體使用的脈搏血氧儀設(shè)備的基本安全和主要性能的專(zhuān)用要求,該設(shè)備包括在正常使用中的任何必要的部件,如脈搏血氧監(jiān)護(hù)儀、脈搏血氧探頭、探頭電纜延長(zhǎng)線等。 這些要求也適用于經(jīng)再加工的脈搏血氧儀設(shè)備,包括脈搏血氧監(jiān)護(hù)儀,血氧探頭和探頭電纜延長(zhǎng)線等。 脈搏血氧儀設(shè)備的應(yīng)用范圍包括,而不僅限于,在醫(yī)療保健機(jī)構(gòu)和家庭中估計(jì)患者的動(dòng)脈血氧飽和度和脈率。 本標(biāo)準(zhǔn)不適用于實(shí)驗(yàn)室研究使用的脈搏血氧儀設(shè)備,也不適用于需采集患者血液樣本的血氧儀。 本標(biāo)準(zhǔn)不適用于胎兒專(zhuān)用脈搏血氧儀設(shè)備。 本標(biāo)準(zhǔn)不適用于放置于患者環(huán)境之外顯示SpO<下標(biāo) 2>數(shù)值的遙測(cè)或主(從)設(shè)備。 本標(biāo)準(zhǔn)的要求替代或修改了GB 9706.1-2007,并預(yù)期優(yōu)先于相應(yīng)的通用要求。

JGJ 312-2013醫(yī)療建筑電氣設(shè)計(jì)規(guī)范

本規(guī)范適用于新建、擴(kuò)建和改建醫(yī)療建筑的電氣設(shè)計(jì)

TS EN 60601-2-49-2016醫(yī)用電氣設(shè)備. 第2-49部分: 多功能病人監(jiān)護(hù)設(shè)備基本安全和主要性能的詳細(xì)要求

This particular standard applies to BASIC SAFETY and ESSENTIAL PERFORMANCE requirements of MULTIFUNCTION PATIENT MONITORING EQUIPMENT as defined in 201.3.63, hereafter referred to as ME EQUIPMENT. This particular standard applies to ME EQUIPMENT used in a hospital environment as well as when used outside the hospital environment, such as in ambulances and air transport.

ABNT NBR IEC 60601-2-49-2003醫(yī)用電氣設(shè)備第一部分2-49-為多功能病人監(jiān)護(hù)設(shè)備安全的特殊要求

Specifies requirements for the safety of multifunction patient monitoring equipment.

DIN EN ISO 11073-00103-2017健康信息學(xué). 個(gè)人保健裝置通信. 第00103部分: 綜述(ISO/IEEE 11073-00103-2015); 英文版本EN ISO 11073-00103-2017

Within the context of the ISO/IEEE 11073 family of standards for device communication, this guide describes the landscape of transport-independent applications and information profiles for personal telehealth devices. These profiles define data exchange, data representation, and terminology for communication between personal health devices and compute engines (e. g., health appliances, set top boxes, cell phones, and personal computers). The guide provides a definition of personal telehealth devices as devices used for life activity, wellness monitoring, and/or health monitoring in domestic home, communal home, and/or mobile applications as well as professional medical usage. Use cases relevant to these scenarios and environments are also presented.

DS/EN 60601-2-49-2002醫(yī)用電氣設(shè)備第2-49部分:多功能病人監(jiān)護(hù)設(shè)備安全的特殊要求

This standard applies to the safety requirements of MULTIFUNCTION PATIENT MONITORING EQUIPMENT as defined in sub-clause 2.2.101. The scope of this document is resticted to EQUIPMENT having either more than one APPLIED PART or having more than one SINGLE FUNCTION, intended for connection to a single PATIENT.