医用电气设备.第2-51部分:单道和多道心电描记器记录和分析的安全性的特殊要求

[中文适用范围]： 补充：本专用标准规定了2.101@ 2.111@ 2.117@ 2.123@ 2.126@中定义的记录和分析单通道和多通道心电图的安全要求，包括基本性能@，以下简称设备。设备可以有人值守或无人值守。本专用标准补充了 IEC 60601-2-25 及其修正案 1 (1999)。 [外文原描述]： Establishes particular requirements, in addition to the requirements of IEC 60601-2-25, for the safety, including essential performance of recording and analysing single channel and multichannel electrocardiographs. These requirements shall apply particularly to - recording electrocardiographs; - electrocardiographs which are part of other medical electrical equipment, for example exercise testing systems, if this equipment is used to record ECGs for diagnostic purposes; - electrocardiographs which are used as output units for ECG data base management systems or electrocardiographs which are used as output units located at other places than the recording unit; - analyzing electrocardiographs, systems, and computing devices which by means of electronic data processing and pattern recognition derive measurements (e.g. intervals and amplitudes) and diagnostic statements from the ECG; - those parts of patient monitors or other specialised electrocardiographs that are capable of performing the functions of the analyzing electrocardiographs.