BS EN 60601-2-63:2015+A1:2019

Comprehensive Healthcare Technology Standard

BS EN 60601-2-63:2015+A1:2019 is a critical standard for the design and manufacture of medical imaging equipment. This British Standard specifies the safety and performance requirements for X-ray equipment for radiotherapy, radiology, and dental applications. It ensures medical devices meet the necessary safety and functionality criteria to protect both patients and operators.

Ensure Compliance and Patient Safety

Compliance with BS EN 60601-2-63:2015+A1:2019 is essential for medical equipment manufacturers. This standard is harmonized with the Medical Devices Directive, meaning it provides a presumption of conformity to the essential requirements. By adhering to this standard, you can demonstrate that your X-ray equipment meets the necessary safety and performance criteria, giving healthcare providers the confidence to use your products.The standard covers a wide range of requirements, including:• Electrical safety• Mechanical safety• Radiation protection• Image quality• Software safety• UsabilityImplementing these requirements helps minimize risks to patients and operators, ensuring the safe and effective use of your medical imaging equipment.

Comprehensive Technical Specifications

BS EN 60601-2-63:2015+A1:2019 provides detailed technical specifications for the design and manufacture of X-ray equipment. Some key areas covered by the standard include:• General requirements for basic safety and essential performance• Radiation protection in the design of radiological equipment• Requirements for the construction of X-ray tube assemblies• Specific requirements for the safety of mammographic X-ray equipment and mammographic stereotactic devices• Particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipmentBy following the technical specifications outlined in this standard, you can ensure your medical imaging equipment meets the necessary safety and performance criteria, giving healthcare providers the confidence to use your products.

Stay Up-to-Date with the Latest Amendments

This standard has been updated with Amendment 1, published in 2019. The amendment incorporates changes and clarifications to the original 2015 version, ensuring the standard remains relevant and up-to-date with the latest industry requirements.It's important to note that this version of the standard (BS EN 60601-2-63:2015+A1:2019) has been replaced by BS EN 60601-2-63:2015+A2:2021, which includes further amendments. However, this previous version (BS EN 60601-2-63:2015+A1:2019) remains current and can be used to demonstrate compliance.By staying informed and implementing the latest version of this standard, you can ensure your medical imaging equipment meets the most up-to-date safety and performance requirements, providing healthcare providers with the confidence they need to use your products.