BS EN ISO 14457:2017

## BS EN ISO 14457:2017 - Healthcare Technology Standard### OverviewBS EN ISO 14457:2017 is the British Standard implementation of the international standard ISO 14457:2017, providing comprehensive guidelines and requirements for the design, development, and use of medical devices and healthcare technology. This standard is an essential reference for manufacturers, healthcare providers, and regulatory bodies to ensure the safety, performance, and quality of medical equipment.### Key Features and Benefits- **Comprehensive Healthcare Technology Guidance**: Covers a wide range of medical devices and equipment, including diagnostic, therapeutic, and assistive technologies.- **Improved Patient Safety**: Establishes rigorous design and manufacturing requirements to minimize risks and enhance the safety of medical devices.- **Regulatory Compliance**: Aligns with the latest EU Medical Device Regulation (MDR) and other international standards, ensuring regulatory compliance.- **Quality Assurance**: Provides a framework for implementing robust quality management systems and processes throughout the product lifecycle.- **Optimized Device Performance**: Specifies requirements for device usability, reliability, and maintainability to optimize clinical outcomes and user satisfaction.- **Environmental Sustainability**: Includes considerations for the environmental impact of medical devices, promoting sustainable practices.### Technical Specifications#### Design and Development- Requirements for the design and development of medical devices, including risk management, usability engineering, and clinical evaluation.- Guidance on the selection of appropriate materials, manufacturing processes, and sterilization methods.- Provisions for the integration of software and information technology components in medical devices.#### Production and Process Controls- Specifications for production and process controls, including validation, process monitoring, and change management.- Requirements for the handling, storage, packaging, and distribution of medical devices.- Provisions for the implementation of traceability systems and post-production surveillance.#### Quality Management- Guidelines for establishing and maintaining a comprehensive quality management system (QMS) for medical devices.- Requirements for the documentation, control, and continuous improvement of quality processes.- Provisions for the management of supplier and customer relationships, as well as internal auditing and management review.#### Usability and Human Factors- Specifications for the integration of human factors engineering throughout the device lifecycle.- Requirements for the assessment and validation of device usability, including user interface design and user training.- Provisions for the consideration of user needs, capabilities, and limitations in the design and development of medical devices.By implementing the guidelines and requirements outlined in BS EN ISO 14457:2017, healthcare organizations and medical device manufacturers can demonstrate their commitment to patient safety, quality, and regulatory compliance, ultimately contributing to improved healthcare outcomes.