BS EN 60601-2-43:2010+A2:2020

## BS EN 60601-2-43:2010+A2:2020 - Medical Imaging Safety StandardBS EN 60601-2-43:2010+A2:2020 is the essential standard for ensuring the safety and performance of X-ray equipment used in diagnostic and interventional medical imaging procedures. This British Standard is identical to the international standard IEC 60601-2-43:2010/AMD2:2019, providing a comprehensive set of requirements for the design, manufacture, and testing of medical X-ray devices.### Key Specifications and Requirements- Applies to X-ray equipment for diagnostic radiology and image-guided interventional procedures- Covers general safety and essential performance requirements- Includes specific tests and criteria for radiation protection, mechanical hazards, and electrical safety- Mandates risk management processes to identify and mitigate potential hazards- Specifies labeling, instructions for use, and accompanying documents### Ensuring Patient and Operator SafetyAt the core of BS EN 60601-2-43 is the imperative to protect patients, medical staff, and the general public from the potential risks associated with medical X-ray imaging. The standard establishes stringent requirements in areas such:- Radiation dose limits and exposure control- Mechanical stability and integrity of equipment- Electrical safety and protection against shock hazards- Thermal safety to prevent burns or discomfort- Usability and human factors engineeringBy complying with this standard, manufacturers can demonstrate that their X-ray devices meet the highest levels of safety and performance, giving healthcare providers and patients the confidence that the equipment is fit for purpose and minimizes potential risks.### Enabling Effective Diagnostic and Interventional ProceduresIn addition to safety requirements, BS EN 60601-2-43 also addresses the essential performance characteristics necessary for medical X-ray equipment to function effectively in diagnostic and image-guided interventional procedures. Key aspects include:- Image quality and spatial resolution parameters- Dose optimization and exposure control mechanisms- Integration with other medical devices and systems- Reliability, availability, and maintainabilityAdherence to this standard ensures that X-ray equipment can reliably produce high-quality images, deliver appropriate radiation doses, and integrate seamlessly with the broader healthcare ecosystem - all while prioritizing the safety of patients and operators.### Compliance and Regulatory AcceptanceBS EN 60601-2-43:2010+A2:2020 is a harmonized standard under the Medical Devices Regulation (EU) 2017/745, making it an essential requirement for CE marking of medical X-ray devices sold in the European Union. The standard is also widely recognized and accepted by regulatory authorities worldwide, facilitating global market access for compliant products.By choosing equipment that conforms to BS EN 60601-2-43, healthcare providers can be confident that they are investing in medical imaging solutions that meet the highest standards of safety, performance, and regulatory compliance.