YY 1139-2000 in English

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。

Scope

This standard specifies the definition, classification, requirements, test methods, inspection rules, markings, instructions for use, packaging, transportation and storage of single-channel and multi-channel cardiograph machines. This standard applies to single-channel and multi-channel electrocardiographs that provide removable electrocardiographic patterns for diagnostic purposes. This product is used to extract the human body's electrocardiogram wave group for morphological and rhythm analysis for clinical diagnosis and research. This standard does not apply to the following devices: devices for obtaining electrocardiogram information from other locations outside the body, heart rate monitors, cardiac monitoring devices, vector electrocardiographs, phonocardiographs, telemetry devices, terminals outside the hospital or uncontrolled environmental conditions Electrocardiograph used under the condition.