BS EN 62366-1:2015+A1:2020 - Medical Devices Usability Engineering

Standard Number: BS EN 62366-1:2015+A1:2020

Pages: 60

Released: 2020-08-19

ISBN: 978 0 580 98164 7

Status: Standard

Overview

The BS EN 62366-1:2015+A1:2020 is a crucial standard for professionals in the medical device industry, focusing on the application of usability engineering to medical devices. This standard is essential for ensuring that medical devices are designed with the end-user in mind, enhancing both safety and effectiveness. Released on August 19, 2020, this document is a comprehensive guide that spans 60 pages, providing detailed insights into usability engineering principles and their application in the medical field.

Why Usability Engineering is Important

Usability engineering is a critical component in the design and development of medical devices. It ensures that devices are not only functional but also user-friendly, reducing the risk of user error and improving patient outcomes. The BS EN 62366-1:2015+A1:2020 standard provides a structured approach to integrating usability into the design process, which is vital for compliance with regulatory requirements and for meeting the needs of healthcare professionals and patients alike.

Key Features of the Standard

• Comprehensive Guidelines: The standard offers detailed guidelines on how to implement usability engineering in the design of medical devices, ensuring that they meet the highest standards of safety and performance.
• Focus on User-Centered Design: Emphasizes the importance of designing devices with the end-user in mind, taking into account the diverse needs and capabilities of healthcare professionals and patients.
• Risk Management Integration: Integrates usability engineering with risk management processes to identify and mitigate potential user-related risks.
• Regulatory Compliance: Helps manufacturers comply with international regulatory requirements, facilitating market access and acceptance.

Who Should Use This Standard?

This standard is indispensable for a wide range of professionals in the medical device industry, including:

• Design Engineers: To ensure that devices are designed with usability in mind from the outset.
• Quality Assurance Professionals: To integrate usability considerations into quality management systems.
• Regulatory Affairs Specialists: To ensure compliance with international standards and regulations.
• Healthcare Providers: To understand the usability aspects of medical devices they use in clinical settings.

Benefits of Implementing Usability Engineering

Implementing usability engineering as outlined in the BS EN 62366-1:2015+A1:2020 standard offers numerous benefits, including:

• Enhanced Safety: By reducing the likelihood of user errors, the standard helps improve the overall safety of medical devices.
• Improved User Satisfaction: Devices designed with usability in mind are more likely to meet user needs and expectations, leading to higher satisfaction levels.
• Increased Market Competitiveness: Products that comply with usability standards are more competitive in the global market, as they meet the demands of both regulators and users.
• Reduced Development Costs: By identifying usability issues early in the design process, manufacturers can avoid costly redesigns and modifications later on.

Conclusion

The BS EN 62366-1:2015+A1:2020 standard is an essential resource for anyone involved in the design, development, and regulation of medical devices. By providing a comprehensive framework for usability engineering, it ensures that medical devices are safe, effective, and user-friendly. Whether you are a design engineer, quality assurance professional, or regulatory affairs specialist, this standard will guide you in creating medical devices that meet the highest standards of usability and performance.

BS EN 62366-1:2015+A1:2020

• 11.040.01 Medical equipment in general
• 11.040 Medical equipment

This part of IEC 62366 specifies a process for a manufacturer to analyse, specify, develop and evaluate the usability of a medical device as it relates to safety. This usability engineering (human factors engineering) process permits the manufacturer to assess and mitigate risks associated with normal use, i.e., correct use and use error. It can be used to identify but does not assess or mitigate risks associated with abnormal use.

 NOTE 1

Safety is freedom from unacceptable risk. Unacceptable risk can arise from use error, which can lead to exposure to hazards including loss or degradation of clinical performance.

NOTE 2 Guidance on the application of usability engineering to medical devices is available in IEC 62366‑2², which addresses not only safety but also aspects of usability not related to safety.

If the usability engineering process detailed in this International Standard has been complied with, then the usability of a medical device as it relates to safety is presumed to be acceptable, unless there is objective evidence to the contrary.

NOTE 3 Such objective evidence can subsequently originate from post-production surveillance.