BS EN 60601-2-4:2011+A1:2019

Comprehensive Standard for Cardiac Defibrillators

BS EN 60601-2-4:2011+A1:2019 is the essential standard for the design, manufacture, and testing of cardiac defibrillators and similar medical electrical equipment. This British Standard specifies the particular requirements for the basic safety and essential performance of cardiac defibrillators, including automated external defibrillators (AEDs).

Ensuring Patient and Operator Safety

This standard is a critical resource for medical device manufacturers, ensuring their products meet the highest levels of safety and performance. It covers a wide range of requirements, including:• Protection against electric shock• Mechanical hazards• Unwanted and excessive radiation• Instability and excessive temperatures• Accuracy of operating data and protection against hazardous outputCompliance with BS EN 60601-2-4:2011+A1:2019 gives medical professionals and patients confidence that defibrillators will function reliably and safely, even in emergency situations.

Harmonized with International Standards

This British Standard is identical to the international standard IEC 60601-2-4:2010/AMD1:2018, ensuring global harmonization and acceptance. It is part of the IEC 60601 series of standards for medical electrical equipment, which are widely recognized as the benchmark for safety and performance.

Key Technical Specifications

• Covers cardiac defibrillators, including manual, semi-automatic, and fully automatic external defibrillators• Specifies requirements for protection against electric shock, mechanical hazards, unwanted and excessive radiation, instability and excessive temperatures, and accuracy of operating data• Includes tests for verifying compliance with safety and performance requirements• Harmonized with the general standard IEC 60601-1 and collateral standards in the IEC 60601 series

Benefits of Compliance

• Ensures the safety of patients and operators during the use of cardiac defibrillators• Provides a comprehensive set of requirements for the design, manufacture, and testing of defibrillators• Facilitates global market access through harmonization with international standards• Demonstrates a commitment to the highest levels of quality and safety in medical electrical equipmentBy adhering to the requirements of BS EN 60601-2-4:2011+A1:2019, medical device manufacturers can confidently bring their cardiac defibrillators to market, knowing they meet the stringent safety and performance standards expected by healthcare professionals and regulatory authorities worldwide.