多功能病人监护设备检测

发布时间：2024-06-21 作者：中析研究所浏览：

GB 9706.8-2009医用电气设备　第2-4部分:心脏除颤器安全专用要求

本专用标准规定了在2.1.101中定义的心脏除颤器的安全要求，本文此后称心脏除颤器为设备。本专用标准不适用于植入式除颤器、遥控除颤器、体外经皮起搏器、分开单立的心脏监护仪(符合GB 9706.25)。使用分开的心电监护电极的心脏监护仪不在本标准适用范围内，除非其被作为自动体外除颤器(AED)心律识别检测或同步心电复律的心搏检测的唯一基准使用。

YY 0784-2010医用电气设备医用脉搏血氧仪设备基本安全和主要性能专用要求

引用GB 9706.1-2007的第1章,不包括以下内容。修改(增加在1.1末尾处) 本标准详细描述了适用于人体使用的脉搏血氧仪设备的基本安全和主要性能的专用要求,该设备包括在正常使用中的任何必要的部件,如脉搏血氧监护仪、脉搏血氧探头、探头电缆延长线等。这些要求也适用于经再加工的脉搏血氧仪设备,包括脉搏血氧监护仪,血氧探头和探头电缆延长线等。脉搏血氧仪设备的应用范围包括,而不仅限于,在医疗保健机构和家庭中估计患者的动脉血氧饱和度和脉率。本标准不适用于实验室研究使用的脉搏血氧仪设备,也不适用于需采集患者血液样本的血氧仪。本标准不适用于胎儿专用脉搏血氧仪设备。本标准不适用于放置于患者环境之外显示SpO<下标 2>数值的遥测或主(从)设备。本标准的要求替代或修改了GB 9706.1-2007,并预期优先于相应的通用要求。

JGJ 312-2013医疗建筑电气设计规范

本规范适用于新建、扩建和改建医疗建筑的电气设计

TS EN 60601-2-49-2016医用电气设备. 第2-49部分: 多功能病人监护设备基本安全和主要性能的详细要求

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医用电气设备第一部分2-49-为多功能病人监护设备安全的特殊要求

Specifies requirements for the safety of multifunction patient monitoring equipment.

DIN EN ISO 11073-00103-2017健康信息学. 个人保健装置通信. 第00103部分: 综述(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医用电气设备第2-49部分:多功能病人监护设备安全的特殊要求

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.