BS EN 60601-2-25:2015

# BS EN 60601-2-25:2015 - Electrocardiographs## OverviewBS EN 60601-2-25:2015 is a critical healthcare technology standard that specifies the safety and performance requirements for electrocardiographic (ECG) monitoring equipment. This standard ensures medical devices used for cardiac monitoring meet the highest levels of safety and functionality, protecting both patients and healthcare professionals.Developed in alignment with IEC 60601-2-25:2011 and EN 62150-1:2005, this British Standard provides a comprehensive framework for the design, manufacture, and testing of ECG devices. By adhering to BS EN 60601-2-25:2015, medical equipment suppliers can demonstrate their commitment to quality, reliability, and regulatory compliance.## Key Features and Benefits### Comprehensive Safety Requirements- Detailed specifications for electrical safety, mechanical safety, and environmental protection- Strict limits on patient leakage current and other potentially hazardous outputs- Robust testing procedures to validate safety performance under normal and fault conditions### Optimized Device Performance- Precise requirements for signal acquisition, processing, and display- Ensures accurate, reliable, and reproducible ECG measurements- Supports advanced features like arrhythmia detection and ST-segment analysis### Regulatory Compliance- Aligns with the latest IEC and EN standards for medical electrical equipment- Facilitates CE marking and other global regulatory approvals- Demonstrates adherence to the essential requirements of the EU Medical Devices Regulation (MDR)### Improved Patient Outcomes- Promotes the use of high-quality, safe, and effective ECG monitoring devices- Supports early detection and diagnosis of cardiac conditions- Helps healthcare providers deliver better patient care and reduce medical errors## Who Needs BS EN 60601-2-25:2015?This standard is essential for any organization involved in the design, manufacture, or distribution of electrocardiographic monitoring equipment, including:- Medical device manufacturers- Original equipment manufacturers (OEMs)- Importers and distributors of ECG devices- Healthcare providers and facilities- Regulatory bodies and testing laboratoriesBy implementing the requirements of BS EN 60601-2-25:2015, these stakeholders can ensure their ECG products meet the highest standards of safety and performance, ultimately contributing to improved patient outcomes and healthcare system efficiency.