National foreword

This British Standard is the UK implementation of EN 62366‑1:2015+A1:2020, incorporating corrigendum December 2015. It is identical to IEC 62366‑1:2015, incorporating amendment 1:2020 and corrigendum July 2016. It supersedes BS EN 62366‑1:2015, which is withdrawn.

The start and finish of text introduced or altered by amendment is indicated in the text by tags. Tags indicating changes to IEC text carry the number of the IEC amendment. For example, text altered by IEC amendment 1 is indicated by .

The start and finish of text introduced or altered by corrigendum is indicated in the text by tags. Text altered by IEC corrigendum July 2016 is indicated in the text by .

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

A list of organizations represented on this committee can be obtained on request to its committee manager.

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 British Standard was published under the authority of the Standards Policy and Strategy Committee on 30 June 2015.

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.
In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications transparently to the maximum extent possible in their national and regional publications. Any divergence between any IEC Publication and the corresponding national or regional publication shall be clearly indicated in the latter.
IEC itself does not provide any attestation of conformity. Independent certification bodies provide conformity assessment services and, in some areas, access to IEC marks of conformity. IEC is not responsible for any services carried out by independent certification bodies.
All users should ensure that they have the latest edition of this publication.
No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and members of its technical committees and IEC National Committees for any personal injury, property damage or other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC Publications.
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.

International Standard IEC 62366‑1 has been prepared by a joint working group of subcommittee 62A: Common aspects of electrical medical equipment used in medical practice, of IEC technical committee 62: Electrical medical equipment in medical practice, and ISO technical committee 210: Quality management and corresponding general aspects for medical devices.

It is published as double logo standard.

This first edition of IEC 62366‑1, together with the first edition of IEC 62366‑2, cancels and replaces the first edition of IEC 62366 published in 2007 and its Amendment 1 (2014).

Part 1 has been updated to include contemporary concepts of usability engineering, while also streamlining the process. It strengthens links to ISO 14971:2019 and the related methods of risk management as applied to safety related aspects of medical device user interfaces. Part 2 contains tutorial information to assist manufacturers in complying with Part 1, as well as offering more detailed descriptions of usability engineering methods that can be applied more generally to medical devices that go beyond safety-related aspects of medical device user interfaces.

The text of this standard is based on the following documents:

Full information on the voting for the approval of this standard can be found in the report on voting indicated in the above table. In ISO, the standard has been approved by 26 P-members out of 26 having cast a vote.

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

In this International Standard, the following print types are used:

Requirements and definitions: roman type.
Means to assess compliance: italic type.
Informative material appearing outside of tables, such as notes, examples and references: in smaller type. Normative text of tables is also in a smaller type
Terms defined inClause 3or as noted: small capitals.

The requirements are followed by means to assess compliance.

In this standard, the conjunctive “or” is used as an “inclusive or” so a statement is true if any combination of the conditions is true.

The verbal forms used in this standard conform to usage described in Annex H of the ISO/IEC Directives, Part 2. For the purposes of this standard, the auxiliary verb:

“shall” means that compliance with a requirement or a test is mandatory for compliance with this standard;
“should” means that compliance with a requirement or a test is recommended but is not mandatory for compliance with this standard;
“may” is used to describe a permissible way to achieve compliance with a requirement or test.

Clauses and subclauses for which a rationale is provided in informative Annex A are marked with an asterisk (*).

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

The committee has decided that the contents of this publication will remain unchanged until the stability date indicated on the IEC web site 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.

NOTE The attention of National Committees and Member Bodies is drawn to the fact that equipment manufacturers and testing organizations may need a transitional period following publication of a new, amended or revised IEC or ISO publication in which to make products in accordance with the new requirements and to equip themselves for conducting new or revised tests. It is the recommendation of the committee that the content of this publication be adopted for mandatory implementation nationally not earlier than 3 years from the date of publication.

The contents of the corrigendum of July 2016 have been included in this copy.

INTRODUCTION

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 (human factors engineering) process are non-intuitive, difficult to learn and difficult to use. As healthcare evolves, less skilled users including patients themselves are now using medical devices and medical devices are becoming more complicated. The design of the user interface to achieve adequate usability requires a different process and skill set than that of the technical implementation of the user interface.

The usability engineering process is intended to identify and minimise use errors and thereby reduce use-associated risks. Some, but not all, forms of incorrect use are suited to control by the manufacturer. The usability engineering process is related to the risk management process as indicated in Figure A.5.

This International Standard describes a usability engineering process to provide acceptable risk related to usability of a medical device. It is intended to be useful not only for manufacturers of medical devices, but also for technical committees responsible for the preparation of particular medical device standards.

This International Standard strictly focuses on applying the usability engineering process to optimize medical device usability as it relates to safety. The companion technical report (IEC 62366‑2 1) is comprehensive and has a broader focus. It focuses not only on usability as it relates to safety, but also on how usability relates to attributes such as TASK accuracy, completeness and efficiency, and user satisfaction.

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

Manufacturers can choose to implement a usability engineering program focused narrowly on safety or more broadly on safety and other attributes, such as those cited above. A broader focus might also be useful to address specific usability engineering expectations, such as the need to confirm that USERS can successfully perform non-safety-related tasks. A manufacturer might also implement a broader program to realize the commercial advantages of a medical device that not only is safe to use but also offers superior usability.

This European Standard was approved by CENELEC on 2015-03-31. CENELEC members are bound to comply with the CEN/CENELEC

Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CENELEC member.

This European Standard exists in three official versions (English, French, German). A version in any other language made by translation under the responsibility of a CENELEC member into its own language and notified to the CEN-CENELEC Management Centre has the same status as the official versions.

CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus, the Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.

European Foreword

The text of document 62A/977/FDIS, future edition 1 of IEC 62366‑1, prepared by SC 62A, "Common aspects of electrical equipment used in medical practice", of IEC/TC 62 "Electrical equipment in medical practice" was submitted to the IEC-CENELEC parallel vote and approved by CENELEC as EN 62366‑1:2015.

The following dates are fixed:

This document supersedes EN 62366:2008.

Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CENELEC [and/or CEN] shall not be held responsible for identifying any or all such patent rights.

Endorsement notice

The text of the International Standard IEC 62366‑1:2015 was approved by CENELEC as a European Standard without any modification.

In the official version, for Bibliography, the following notes have to be added for the standards indicated:

European foreword to amendment A1

The text of document 62A/1386/FDIS, future IEC 62366‑1/A1, prepared by SC 62A "Common aspects of electrical equipment used in medical practice" of IEC/TC 62 "Electrical equipment in medical practice" was submitted to the IEC-CENELEC parallel vote and approved by CENELEC as EN 62366‑1:2015/A1:2020.

The following dates are fixed:

Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CENELEC shall not be held responsible for identifying any or all such patent rights.

Endorsement notice

The text of the International Standard IEC 62366‑1:2015/A1:2020 was approved by CENELEC as a European Standard without any modification.

In the official version, for Bibliography, the following notes have to be added for the standards indicated:

INTRODUCTION to Amendment 1

The first edition of IEC 62366‑1 was published in 2015. Since its publication, experts working in the field have identified several inaccuracies that warrant correction. In total, 22 issues were identified and presented to the National Committee members of IEC/SC 62A and to the Member Bodies of ISO/TC 210. A majority of the members of both committees that stated a position supported developing this amendment to address the identified issues while making no fundamental changes to the usability engineering process as originally conceived in IEC 62366‑1:2015.

To assist the user to implement the usability engineering process, the technical report IEC TR 62366‑2 is available, which contains tutorial information to assist manufacturers in complying with this document, as well as more generally to design medical devices that goes beyond safety-related aspects of user interfaces and offers more detailed descriptions of usability engineering methods that can be applied.

1 * Scope

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 62366‑2 2 , 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.

2 Normative references

3 Terms and definitions

4 Principles

4.1 General requirements

4.2 * Usability engineering file

4.3 Tailoring of the usability engineering effort

5 * Usability engineering process

5.1 * Prepare use specification

5.2 * Identify user interface characteristics related to safety and potential use errors

5.3 * Identify known or foreseeable hazards and hazardous situations

5.4 * Identify and describe hazard-related use scenarios

5.5 * Select the hazard-related use scenarios for summative evaluation

5.6 * Establish user interface specification

5.7 * Establish user interface evaluation plan

5.8 * Perform user interface design, implementation and formative evaluation

5.9 * Perform summative evaluation of the usability of the user interface

5.10 User interface of unknown provenance

Bibliography

BS EN 62366-1:2015+A1:2020

Medical devices - Application of usability engineering to medical devices

Current

Published:

31 Aug 2020