BS EN 60601-2-27:1995 Medical electrical equipment. Part 2. Particular requirements for safety - Specification for electrocardiographic monitoring equipment
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BS EN 60601-2-27:1995 is a European standard that specifies the safety requirements and testing methods for electrocardiographs (ECG). ECGs are medical devices that are used to measure and record the electrical activity of the heart, typically to diagnose or monitor cardiac disorders.
The standard covers several aspects of safety, including electrical safety, mechanical safety, and fire safety. It also specifies requirements for electromagnetic compatibility, accuracy of measurements, and user safety. The standard provides guidance on the testing procedures for these safety requirements.
In addition, the standard specifies requirements for the labeling and documentation of electrocardiographs, including information on their safety features and operating instructions.
It is important to note that this standard has been superseded by the updated version, EN 60601-2-27:2015. This newer version includes additional safety requirements and updated testing procedures to reflect advances in technology and changes in industry practices.
This Standard specifies the particular safety requirements for ELECTROCARDIOGRAPHIC (ECG) MONITORING EQUIPMENT as defined in 2.101 and hereinafter also referred to as EQUIPMENT.
Telemetry monitors, ambulatory ("Holter") monitors and other recording devices are outside the scope of this Particular Standard.
BS EN 60601-2-27:1995 Medical electrical equipment. Part 2. Particular requirements for safety - Specification for electrocardiographic monitoring equipment
