National foreword

This Published Document is the UK implementation of IEC/TR 62366‑2:2016. Together with BS EN 62366‑1:2015, it supersedes BS EN 62366:2008+A1:2015 which will be withdrawn on 31 March 2018.

The UK participation in its preparation was entrusted by Technical Committee CH/62, Electrical Equipment in Medical Practice, to Subcommittee CH/62/1, Common aspects of Electrical Equipment used in Medical Practice.

A list of organizations represented on this subcommittee can be obtained on request to its secretary.

This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application.

Compliance with a British Standard cannot confer immunity from legal obligations.

This Published Document was published under the authority of the Standards Policy and Strategy Committee on 31 May 2016.

FOREWORD

The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising all national electrotechnical committees (IEC National Committees). The object of IEC is to promote international co-operation on all questions concerning standardization in the electrical and electronic fields. To this end and in addition to other activities, IEC publishes International Standards, Technical Specifications, Technical Reports, Publicly Available Specifications (PAS) and Guides (hereafter referred to as “IEC Publication(s)”). Their preparation is entrusted to technical committees; any IEC National Committee interested in the subject dealt with may participate in this preparatory work. International, governmental and non-governmental organizations liaising with the IEC also participate in this preparation. IEC collaborates closely with the International Organization for Standardization (ISO) in accordance with conditions determined by agreement between the two organizations.
The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international consensus of opinion on the relevant subjects since each technical committee has representation from all interested IEC National Committees.
IEC Publications have the form of recommendations for international use and are accepted by IEC National Committees in that sense. While all reasonable efforts are made to ensure that the technical content of IEC Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any misinterpretation by any end user.
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Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is indispensable for the correct application of this publication.
Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of patent rights. IEC shall not be held responsible for identifying any or all such patent rights.

The main task of IEC technical committees is to prepare International Standards. However, a technical committee may propose the publication of a technical report when it has collected data of a different kind from that which is normally published as an International Standard, for example "state of the art".

IEC 62366‑2, which is a technical report, has been prepared by a joint working group of subcommittee 62A: Common aspects of electrical equipment used in medical practice, of IEC technical committee 62: Electrical equipment in medical practice, and technical committee ISO/TC 210: Quality management and corresponding general aspects for medical devices.

It is published as a double logo standard.

The text of this technical report is based on the following documents:

Full information on the voting for the approval of this technical report can be found in the report on voting indicated in the above table. In ISO, the standard has been approved by 23 P-members out of 36 having cast a vote.

This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.

In this Technical Report, the following print types are used.

Guidance for the implementation of a usability engineering (human factors engineering) process required by IEC 62366‑1:2015 and definitions): roman type.
Additional information about usability engineering best practices: italic type.
Informative material appearing outside of tables, such as notes, examples and references: in smaller type. Text of tables is also in a smaller type.
Terms defined inClause 3or as noted: small capitals.

A list of all parts in the IEC 62366, published under the general title Medical devices, can be found on the IEC website.

This technical report is to be read in conjunction with IEC 62366‑1:2015.

The committee has decided that the contents of this publication will remain unchanged until the stability date indicated on the IEC website under "http://webstore.iec.ch" in the data related to the specific publication. At this date, the publication will be

reconfirmed,
withdrawn,
replaced by a revised edition, or
amended.

A bilingual version of this publication may be issued at a later date.

INTRODUCTION

This technical report provides medical device manufacturers with guidance on how to integrate usability engineering (also called human factors engineering) principles and user interface design practices into their overall medical device development processes. The technical report recognizes that all medical devices involving human interaction present opportunities for optimization through the application of usability engineering and seeks to guide the medical device manufacturers efforts.

This report concerns the quality of user interactions with medical devices that are as varied as acquiring information on a display, pressing a physical button or on-screen touch target button, selecting items on a software menu, attaching accessories to a medical device and interpreting warnings as well as understanding relevant aspects for the proper use of the medical device by reading the accompanying documentation. usability engineering programs, if properly implemented, can increase the likelihood that users are able to perform such actions correctly and without hindrance.

Medical practice is increasingly using medical devices for observation and treatment of patients. use errors caused by inadequate medical device usability have become an increasing cause for concern. Many of the medical devices developed without applying a usability engineering process are non-intuitive, difficult to learn and difficult to use. In addition, medical devices developed without applying usability engineering or developed with incomplete or inadequate application of usability engineering can include design shortcomings that can lead to use errors, particularly with varied users and use environments, which can lead to harm.

As healthcare evolves, less skilled users including patients themselves are now using medical devices and medical devices are becoming more complicated. While medical devices become increasingly sophisticated, they can be more likely to induce use errors. If not properly designed or safeguarded, medical devices could contribute to hazardous situations and can be a source of harm. An appropriate-tailored investment in usability engineering ensures that medical devices will have acceptable risk and usability and that design shortcomings are identified and removed from the user interface. Accordingly, this technical report emphasizes the importance of designing for usability, with an emphasis placed on ensuring safety.

Ascribing to this report helps manufacturers respond effectively to regulatory expectations that call for the application of usability engineering during the medical device development process. It also helps manufacturers produce medical devices that have well designed user interfaces that satisfy users. As such, it can propel a manufacturer beyond a common sense approach to user interface design to an approach that fully embraces usability engineering as an essential step toward design excellence. Other beneficiaries of this document's guidance include authorities having jurisdiction (AHJ) and medical device consumers who share a common interest in safe and effective medical devices.

The guidance provided in this report applies to all medical devices, including those used by laypersons and/or healthcare professionals; medical devices that perform just one function and those that perform many functions; user interfaces in the form of hardware, software, documentation, and packaging; medical devices that fit in a pocket, sit on a table, ride on a cart, or fill a room; and medical devices that require no prior operational knowledge or call for training before use. Accordingly, it applies to a pen injector, glucose meter, infusion pump, patient monitor, anaesthesia workstation, and radiation therapy system, just to name a few medical devices.

1 Scope and purpose

1.1 Scope

This Part of IEC 62366, 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 62366‑1:2015and 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.

NOTE 1 Safety is freedom from unacceptable risk, which is described in ISO 14971. Unacceptable risk can arise from use error, which can lead to exposure to direct physical hazards or to loss or degradation of clinical performance.

NOTE 2 The process for a manufacturer to analyse, specify, develop and evaluate the usability of a medical device, as it relates to safety is found in IEC 62366‑1:2015.

This technical report has two main themes:

information about efficient ways to implement elements required by IEC 62366‑1:2015; and
additional information, in particular how usability relates to attributes such as task efficiency and user satisfaction, which can enhance a medical device’s commercial success.

This technical report discusses the business benefits of usability engineering, the basics of applicable analysis and design techniques, medical device usability evaluation approaches, efficient ways to address usability engineering project implementation issues (e.g. integration into a quality management system) and provides a list of useful usability engineering resources.

This technical report also can be useful for other healthcare products (e.g. drug packaging and drug labelling, drug-medical device combination products and health IT software).

1.2 Purpose

The intent of this technical report is to provide guidance related to:

the essential elements of a usability engineering process as required by IEC 62366‑1:2015, including:
- user research techniques,
- analysis techniques,
- design techniques, and
- medical device usability evaluation approaches (e.g. usability testing);
the planning and implementation of the usability engineering process;
the benefits of applying usability engineering; and
improve user satisfaction.

This technical report is intended to be read in conjunction with IEC 62366‑1:2015.

The intended reader for this technical report includes the people or organisations that are involved with planning, funding, managing, and performing research, design, evaluation and regulatory-related activities (i.e. approbation) related to medical devices, including, but not limited to:

company, department, project, and product managers;
design and engineering professionals (e.g. human factors engineers, industrial designers, technical writers, information designers, software developers, mechanical engineers, electrical engineers, packaging engineers);
medical researchers and other interested clinicians;
marketers and other business professionals in the medical device industry;
quality or regulatory staffs of medical device manufacturers (for example, regulatory affairs, risk management or quality management roles); and
writers of product standards.

This technical report is neither intended as the sole source of usability engineering guidance for medical device manufacturers, nor a complete substitute for human factors expertise. Rather, it is intended to provide readers with a general understanding of how to perform usability engineering in an economic manner. Readers are advised to supplement the knowledge they gain from this report with knowledge acquired from complementary documents including those specific to the medical device of interest. A list of useful usability engineering resources and further readings is provided in Annex A.

This report does not address detailed usability engineering design guidance or requirements, such as recommendations on the proper size of text on a computer screen, appropriate ways to arrange a workstation's displays and controls, or characteristics of an appropriate alarm signal. Such information can be found in other documents, such as [1][2][3][4]1.

This technical report does not describe a specific set of usability engineering activities that suit all design projects. Instead, it gives guidance for a general usability engineering process requiring further shaping and tailoring to suit a given development project's needs. Usability engineering practice varies widely throughout the world and even within specific countries, companies, and company units. This variation is partly due to the diversity found among usability engineering practitioners who can have a background in one or more of various professional fields, such as engineering, psychology, or design. Practice differences also exist due to the wide variety of medical devices, which range from seemingly simple syringes to complex imaging systems, some of which are used in hospitals, clinics, and/or the home by various types of medical professionals as well as laypersons (e.g. patients and caregivers who take care of patients, such as a child or spouse).

2 Normative references

3 Terms and definitions

4 Mapping between the requirements of IEC 62366‑1 and the guidance of IEC TR 62366‑2

5 Background and justification of the usability engineering program

5.1 How safety relates to usability

5.2 Reasons to invest in usability engineering

6 How to implement a usability engineering program

6.1 Effective usability engineering programs

6.2 Effective usability engineering projects and plans

6.3 Apply an appropriate level of usability engineering expertise

6.4 Ensure the necessary resources are available and well timed

6.5 Risk management as it relates to usability engineering

6.6 Usability engineering file

6.7 Tailoring the usability engineering effort

7 Overview of the usability engineering process

8 Prepare the use specification

8.1 Initiate use specification

8.2 Analyse the intended users, anticipated user tasks and intended use environments

8.3 Finalize the use specification

8.4 Recommended methods for developing the use specification

9 Identify user interface characteristics related to safety and potential use errors

9.1 General

9.2 Task analysis

9.3 Function analysis

9.4 Identify and analyse known problems

10 Identify known or foreseeable hazards and hazardous situations

11 Identify and describe hazard-related use scenarios

11.1 Define use scenarios

11.2 Use scenarios as they relate to risk management

11.3 Identify hazard-related use scenarios

11.4 Methods to define and analyse hazard-related use scenarios

12 Select the hazard-related use scenarios for summative evaluation

12.1 General

12.2 Selection of the hazard-related use scenarios based on severity

12.3 Selection of hazard-related use scenarios based on other circumstances

13 Establish user interface specification

13.1 Development of the user interface specification

13.2 Accompanying documentation and training

14 Establish user interface evaluation plan

14.1 Specify how the user interface design will be explored and evaluated

14.2 Formative evaluation planning

14.3 Summative evaluation planning

14.4 Usability test planning

14.5 Example usability test protocol and report

15 Design and implement the user interface and training

15.1 General

15.2 Develop conceptual model(s)

15.3 Design software user interfaces (if applicable)

15.4 Design hardware user interfaces (if applicable)

15.5 Design materials necessary for training and training

15.6 Develop detailed designs

15.7 Verify the design of the user interface

16 Perform formative evaluations

16.1 Conduct multiple formative evaluations

16.2 Recommended methods for formative evaluation

16.3 Analysis of formative evaluation results

17 Perform summative evaluation

17.1 General

17.2 Conduct a summative evaluation

17.3 Data collection

17.4 Data analysis

18 Document the usability engineering project

19 Post-production review and analysis

Bibliography

PD IEC/TR 62366-2:2016

Medical devices - Guidance on the application of usability engineering to medical devices

Current

Published:

27 Apr 2016