BS 2646-1:2021

Comprehensive Healthcare Technology Standard: BS 2646-1:2021

Ensure the highest standards of patient care and safety with BS 2646-1:2021, the essential healthcare technology standard from the British Standards Institution (BSI). This comprehensive document provides detailed guidance and requirements for the design, manufacture, and use of medical devices and related technologies.

Key Features and Benefits:

• Covers a wide range of healthcare technologies, including diagnostic equipment, therapeutic devices, and digital health solutions
• Helps organizations comply with regulatory requirements and industry best practices
• Promotes the development of safe, effective, and user-friendly medical technologies
• Supports the delivery of high-quality, patient-centered healthcare services
• Applicable to both public and private healthcare providers, as well as medical device manufacturers

Detailed Technical Specifications

BS 2646-1:2021 is structured into the following key sections:

General Requirements

• Definitions and terminology related to healthcare technology
• Principles of safety, performance, and usability
• Risk management and quality assurance processes

Design and Development

• Requirements for the design and development of medical devices
• Considerations for human factors and user-centered design
• Validation and verification procedures

Manufacturing and Production

• Guidelines for the production and assembly of medical technologies
• Specifications for materials, components, and manufacturing processes
• Traceability and change control requirements

Installation, Maintenance, and Decommissioning

• Recommendations for the safe installation and commissioning of medical devices
• Maintenance and servicing procedures to ensure ongoing performance and safety
• Guidance on the proper decommissioning and disposal of healthcare technologies

Compliance and Regulatory Alignment

BS 2646-1:2021 is aligned with relevant international standards and regulations, including:

• ISO 13485:2016 - Medical devices: Quality management systems
• IEC 60601 series - Medical electrical equipment and systems
• EU Medical Device Regulation (MDR) 2017/745
• FDA Quality System Regulation (21 CFR Part 820)

By implementing the requirements and recommendations of BS 2646-1:2021, healthcare organizations and medical device manufacturers can demonstrate compliance with these key regulatory frameworks and ensure the safety and efficacy of their products and services.