规定了动态心电图（ECG）的基本安全性和基本性能 系统。本标准范围内包括以下类型的系统:a） 提供ECG的连续记录和连续分析，允许进行全面的重新分析 结果基本相似。系统可能首先记录和存储ECG，并在稍后的时间进行分析 单独装置或同时记录和分析心电图。使用的存储介质类型为 与本标准无关； b）提供持续分析且仅限于 不允许完全重新分析心电图的部分或有限记录。

Specifies the basic safety and essential performance of ambulatory electrocardiographic (ECG) systems. Within the scope of this standard are systems of the following types: a) systems that provide continuous recording and continuous analysis of the ECG allowing full re-analysis giving essentially similar results. The systems may first record and store the ECG and analyze it later on a separate unit or record and analyze the ECG simultaneously. The type of storage media used is irrelevant with regard to this standard; and b) systems that provide continuous analysis and only partial or limited recording not allowing a full re-analysis of the ECG.