IEC/TR 62366-2:2016

Name: IEC/TR 62366-2:2016 — Medical devices — Part 2: Guidance on the application of usability engineering to medical devices
SKU: IEC/TR 62366-2:2016
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Medical devices — Part 2: Guidance on the application of usability engineering to medical devices

Название (английский):

IEC/TR 62366-2:2016

Medical devices — Part 2: Guidance on the application of usability engineering to medical devices

Статус документа:: Действующий
Формат:: Электронный (PDF)
Количество страниц:: 94
Дата публикации:: 28 апреля 2016 г.
Издание:: IEC TR 62366 edition 1 version 1
ICS:: 11.040.01

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Описание (английский):

IEC TR 62366-2:2016(E), which is a Technical Report, contains background information and provides guidance that addresses specific areas that experience suggests can be helpful for those implementing a USABILITY ENGINEERING (HUMAN FACTORS ENGINEERING) PROCESS both as defined in IEC 62366-1:2015 and as supporting goals other than SAFETY. This technical report is not intended to be used for regulatory purposes. It contains no requirements and only provides guidance and tutorial information.

Abstract

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Упомянутые в описании и другие стандарты IEC

Overview

IEC/TR 62366-2:2016 is a Technical Report published by the International Electrotechnical Commission (IEC), in close cooperation with ISO. This guidance document focuses on the application of usability engineering, also known as human factors engineering, to the development of medical devices. While IEC/TR 62366-2:2016 does not set enforceable requirements and is not intended for regulatory use, it provides valuable background information, practical advice, and tutorial insights for manufacturers and stakeholders aiming to improve device usability and user satisfaction, in addition to advancing patient safety.

IEC/TR 62366-2:2016 complements the requirements-based IEC 62366-1:2015 by addressing effective implementation strategies and broader benefits of usability engineering in the medical device industry.

Key Topics

Background and Benefits of Usability Engineering

Outlines why usability engineering is essential for safe and effective medical device operation, helping reduce use errors and improve both safety and user satisfaction.
Discusses the relationship between device usability, user experience, and overall clinical performance.

Planning and Implementing a Usability Engineering Process

Offers strategies for integrating usability engineering into the device development lifecycle.
Encourages tailored approaches based on device complexity, user types, and use environments.

Usability Engineering Process Essentials

Introduces user research methods, analysis techniques, iterative design, and evaluation approaches, including usability testing.
Emphasizes the importance of involving end users throughout the development process to identify and mitigate potential use errors.

Relationship to Risk Management

Describes how usability engineering supports risk management activities, aligning with concepts from ISO 14971.
Guides identification and analysis of potential hazards and use scenarios that could lead to harm.

Project and Resource Management

Provides advice on assembling cross-functional teams with appropriate expertise in usability and human factors engineering.
Stresses the importance of integrating usability tasks into the quality management system (QMS).

Applications

IEC/TR 62366-2:2016 applies to all types of medical devices-whether software or hardware-used by healthcare professionals or laypersons, across varied environments from hospitals to home care. Key practical applications include:

Design and Development: Supports teams in creating user-friendly interfaces, clear displays, and intuitive controls to minimize training needs and prevent errors.

Usability Testing: Helps manufacturers plan and execute formative and summative usability tests, capturing real-world feedback to refine product design.

Product Improvement: Offers techniques to uncover known issues and leverage user feedback for subsequent device generations.

Cross-disciplinary Collaboration: Guides communication among engineers, designers, regulatory experts, and clinicians for holistic product development.

Market Success: Enhances competitive advantage by ensuring devices are not only compliant with safety standards but also satisfy user expectations for efficiency and ease of use.

Related Standards

IEC 62366-1:2015 – Medical devices – Part 1: Application of usability engineering to medical devices (contains process requirements and should be used jointly with Part 2 for comprehensive understanding).

ISO 14971 – Medical devices – Application of risk management to medical devices (reference standard for safety and risk concepts addressed within usability engineering).

Additional Resources: The report references further readings and external resources for more detailed usability guidelines, design principles, and human factors methods-particularly useful for device-specific applications, broader product safety, and industry best practices.

For optimal results, organizations are encouraged to integrate IEC/TR 62366-2:2016 into their medical device usability engineering programs and reference related standards throughout the product development lifecycle. This ensures the highest levels of device safety, effectiveness, and user satisfaction.

IEC/TR 62366-2:2016

Abstract

Похожие стандарты

Overview

Key Topics

Applications

Related Standards

Технические детали

IEC 62366-1:2015

Medical devices - Part 1: Application of usability engineering to medical devices

ISO 14971:2007

Medical devices - Application of risk management to medical devices

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