YY1139-2000单道和多道心电图机.pdf

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1、C39备案号:7059-2000yy中华人民共和国医药行业标准YY1139-2000单道和多道心电图机Singleandmultichannelelectrocardiograph2000一01一31发布2000一07一01实施国家药品监督管理局发布YY1139-2000目次前言·····································································································”··········⋯⋯I1范围······

2、·······························，.················“·················································⋯⋯12引用标准·························································································”·······“·”⋯⋯13定义·········”·········································

3、·········。················································⋯⋯14分类·············································································································⋯⋯25要求························································“············”···············

4、···············⋯⋯36试验方法”··”··································································································⋯⋯67检验规则··················································································，···················”·”·⋯128标志、使用说明书·············

5、·······················“·····················································⋯⋯139包装、运输、贮存·······························································..·..·..·..·············..·····⋯⋯14YY1139-2000前言本标准是YY91139-1999《单道和多道心电图机》行业标准的修订版本。本标准与YY91139-1999的主要技术差异如下:

6、增补了术语和定义以及热线阵记录方式心电图机的有关技术要求，并按GB/T14710-1993(医用电气设备环境要求及试验方法》对仪器的环境试验要求进行修改。本标准修订时，为了与有关标准相协调，对GB10793-1989《心电图机专用安全要求》同时进行了修订。本标准应与GB10793-2000(医用电气设备第2部分:心电图机专用安全要求》同时执行。本标准自实施之日起代替YY91139-1999,本标准由全国医用电器标准化技术委员会提出。本标准由全国医用电器标准化技术委员会医用电子仪器标准化分技术委员会归口。本标准由上海医疗器械

7、高技术公司负责起草。本标准主要起草人许金茹、马奎庭。本标准于1977年首次发布，于1983年11月第一次修订。中华人民共和国医药行业标准YY1139-2000.单道和多道心电图机代替YY91139-1999Sin刃eandmultichannelelectrocardiograph范围本标准规定了单道和多道心图机的定义、分类、要求、试验方法、检验规则、标志、使用说明书、包装、运输和贮存。本标准适用于提供可取下供诊断用的心电图图谱的单道和多道心电图机。该产品用于提取人体的心电波群进行形态和节律分析，供临床诊断和研究。本标准不

8、适用于下列装置:人体外的其他位置取得心电图信息的装置、心率计、心脏监视装置、心电向量图机、心音图机、遥测装置、在医院外的终端或不受控环境条件下使用的心电图机等。2引用标准下列标准所包含的条文，通过在本标准中引用而构成为本标准的条文，本标准出版时，所示版本均为有效。所有标准都会被修订，使用本标准的各方应探