IEC 62366:2007/Amd 1:2014

Medical devices — Application of usability engineering to medical devices — Amendment 1

Dispositifs médicaux — Application de l'ingénierie de l'aptitude à l'utilisation aux dispositifs médicaux — Amendement 1

General Information

• Status: Withdrawn
• Publication Date: 28-Jan-2014
• Withdrawal Date: 28-Jan-2014
• ICS: 11.040.01 - Medical equipment in general
• Technical Committee: ISO/TC 210 - Quality management and corresponding general aspects for medical devices
• Drafting Committee: ISO/TC 210/JWG 3 - Joint ISO/TC 210-IEC/SC 62A WG : Medical device usability
• Current Stage: 9599 - Withdrawal of International Standard
• Completion Date: 25-Feb-2015

Relations

• Revised: IEC 62366-1:2015 - Medical devices — Part 1: Application of usability engineering to medical devices
• Effective Date: 12-Feb-2014
• Amends: IEC 62366:2007 - Medical devices — Application of usability engineering to medical devices
• Effective Date: 09-May-2020

Standards Content (Sample)

IEC 62366
Edition 1.0 2014-01
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
A MENDMENT 1
AM ENDEMENT 1

Medical devices – Application of usability engineering to medical devices

Dispositifs médicaux – Application de l'ingénierie de l'aptitude à l'utilisation aux
dispositifs médicaux

IEC 62366:2007-10/AMD1:2014-01(EN-FR)

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IEC 62366


Edition 1.0 2014-01




INTERNATIONAL



STANDARD




NORME



INTERNATIONALE




A MENDMENT 1

AM ENDEMENT 1





Medical devices – Application of usability engineering to medical devices



Dispositifs médicaux – Application de l'ingénierie de l'aptitude à l'utilisation aux


dispositifs médicaux

















INTERNATIONAL

ELECTROTECHNICAL

COMMISSION


COMMISSION

ELECTROTECHNIQUE

PRICE CODE
INTERNATIONALE

CODE PRIX G


ICS 11.040 ISBN 978-2-8322-1134-2



Warning! Make sure that you obtained this publication from an authorized distributor.

Attention! Veuillez vous assurer que vous avez obtenu cette publication via un distributeur agréé.

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– 2 – 62366 Amend.1 © IEC:2014
FOREWORD
This amendment 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 technical committee ISO/TC 210:
Quality management and corresponding general aspects for medical devices.
The text of this amendment is based on the following documents:
FDIS Report on voting
62A/889/FDIS 62A/897/RVD

Full information on the voting for the approval of this amendment 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 23 having cast a vote.
The committee has decided that the contents of this amendment and the base 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.
_____________

INTRODUCTION TO THE AMENDMENT
The first edition of IEC 62366 was published in 2007. This amendment is intended to add
urgently needed requirements to deal with legacy devices for which the user interface design
is of unknown provenance. Work is continuing in parallel to develop the second edition of
IEC 62366.

FOREWORD
Add the following note at the end of the Foreword:
NOTE The attention of National Committees 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.

INTRODUCTION
Add after the last paragraph of the introduction the following paragraph:

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62366 Amend.1 © IEC:2014 – 3 –
Amendment 1 updates the standard to add urgently needed requirements to deal with legacy
devices where the USER INTERFACE design is of unknown provenance.
2 Normative references
In the existing introductory paragraph, replace the first sentence with:
The following documents, in whole or in part, are normatively referenced in this document and
are indispensable for its application.
3 Terms and definitions
Add the following new definition:
3.27
USER INTERFACE OF UNKNOWN PROVENANCE
UOUP
USER INTERFACE or part of a USER INTERFACE of a MEDICAL DEVICE previously developed for
which adequate RECORDS of the USABILITY ENGINEERING PROCESS of this standard are not
available
5 USABILITY ENGINEERING PROCESS
Add the following new subclause:
5.10 * USER INTERFACE OF UNKNOWN PROVENANCE (UOUP)
Instead of all of the requirements of 5.1 through 5.9, UOUP may be evaluated according to
Annex K.
Compliance is checked by application of Annex K.
Annex A – General guidance and rationale
A.2 Rationale for requirements in particular clauses and subclauses
Add, after the existing paragraph of the rationale for Clause 7, the following new rationale.
Subclause K.2.1 – Application specification
The application specification is the essential source used to identify the most important
characteristics related to the use of a MEDICAL DEVICE. When evaluating a USER INTERFACE
including UOUP, the ACCOMPANYING DOCUMENTS can provide a valuable source for
retrospectively establishing the application specification.
Furthermore, the application specification needs to be consistent with the ACCOMPANYING
DOCUMENTS. Therefore it is best practice to carefully review the ACCOMPANYING DOCUMENTS.
Elements of the application specification which cannot be derived (determined) from the
ACCOMPANYING DOCUMENTS need to be established using other sources.
Subclause K.2.3 – Review of post-production information
Available post-production information is reviewed to identify known problems with the MEDICAL
DEVICE with UOUP that might have been caused by USABILITY problems in the USER INTERFACE.

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– 4 – 62366 Amend.1 © IEC:2014
Because the post-production information can be incomplete (e.g., due to under-reporting of
adverse events and customer complaints) and the root cause of the problem can be difficult to
identify, the MANUFACTURER should analyse the SEVERITY of the potential HARM associated with
the identified problem rather than the number of event reports, customer complaints or
product recalls.
Add, immediately following existing Annex J, the following new annex:

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62366 Amend.1 © IEC:2014 – 5 –
Annex K
(normative)

Evaluation of a USER INTERFACE OF
UNKNOWN PROVENANCE (UOUP)

K.1 General
Annex K was created in recognition of the fact that many MANUFACTURERS will be interested in
applying the tools defined in this standard to USER INTERFACES or parts of USER INTERFACES
that have already been commercialized prior to the publication of this standard. Such USER
INTERFACES or parts of USER INTERFACES were not developed using the PROCESSES of
IEC 62366 and as a result are of unknown provenance with respect to these PROCESSES.
Since this standard focuses on USABILITY ENGINEERING as part of the product development
PROCESS, it was determined that an appropriately scaled (as described in subclause 4.3 of this
standard) and alternative PROCESS should be developed to cover these USER INTERFACES or
parts of USER INTERFACES of unknown provenance.
The following represents such a PROCESS that relies, wherever possible, on existing
documentation created during the development of a legacy USER INTERFACE or part of a USER
INTERFACE. It also attempts to allow the PROCESS to be applied utilizing organizational
resources as efficiently as possible. When completed, it will result in the creation of a
USABILITY ENGINEERING FILE and assure that the RISK MANAGEMENT FILE identifies RISKS caused
by USABILITY problems of the USER INTERFACE.
The PROCESS of this annex can be applied to UOUP for a USER INTERFACE or part of a USER
INTERFACE for which adequate records of the development using the USABILITY ENGINEERING
PROCESS of IEC 62366:2007 are not available. However, if any modifications are made to the
USER INTERFACE or its parts, only the unchanged parts of the USER INTERFACE remain UOUP and
the changed parts of the USER INTERFACE are subject to 5.1 to 5.9.
EXAMPLE 1 For an unchanged legacy USER INTERFACE that was designed and developed prior to the publication
of IEC 62366:2007, the USER INTERFACE is evaluated using this annex for determining conformance to this
standard.
EXAMPLE 2 A USER INTERFACE, without adequate records of development to IEC 62366:2007, is subsequently
modified. The modified parts are evaluated using 5.1 to 5.9 for determining conformance to this standard. The
unmodified parts of the USER INTERFACE are evaluated using this annex for determining conformance to this
standard.
EXAMPLE 3 A USER INTERFACE that was designed and developed prior to the publication of IEC 62366:2007 is
subsequently modified by adding a new software feature. The USER INTERFACE of the added software feature and
all parts of the USER INTERFACE that are affected by the added software feature are evaluated using 5.1 to 5.9 for
determining conformance to this standard. The unmodified parts of the original USER INTERFACE are evaluated using
this annex for determining conformance to this standard.
EXAMPLE 4 An existing USER INTERFACE is changed to rely on a general purpose component for which no
adequate records of the development using IEC 62366:2007 exist. Changes to the existing USER INTERFACE are
needed to integrate the general purpose component into the MEDICAL DEVICE. The necessary changes of the USER
INTERFACE caused by integrating the general purpose component are evaluated using 5.1 to 5.9 for determining
conformance to this standard. The unmodified parts of the original USER INTERFACE are evaluated using this annex
for determining conformance to this standard.
K.2 USABILITY ENGINEERING PROCESS for USER INTERFACE OF UNKNOWN
PROVENANCE
K.2.1 * Application specification
The MANUFACTURER shall establish an application specification as required in 5.1. The
MANUFACTURER shall record this application specification in the USABILITY ENGINEERING FILE.

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– 6 – 62366 Amend.1 © IEC:2014
Compliance is checked by inspection of the USABILITY ENGINEERING FILE.
K.2.2 PRIMARY OPERATING FUNCTIONS
The MANUFACTURER shall identify and record the PRIMARY OPERATING FUNCTIONS of the MEDICAL
DEVICE with UOUP as required by 5.4.
Compliance is checked by inspection of the USABILITY ENGINEERING FILE.
K.2.3 * Review of post-production information
The MANUFACTURER of the MEDICAL DEVICE with UOUP shall review available post-production
information including complaints and field reports for incidents or near incidents and including
complaints associated with the use of the PRIMARY OPERATING FUNCTIONS.
All identified cases of USE ERROR that could result in a HAZARDOUS SITUATION or those cases
where field information suggests HAZARDS or HAZARDOUS SITUATIONS that could have been
caused by inadequate USABILITY shall be recorded in the USABILITY ENGINEERING FILE and
addressed in K.2.4 and K.2.5.
Compliance is checked by inspection of the USABILITY ENGINEERING FILE.
K.2.4 HAZARDS AND HAZARDOUS SITUATIONS caused by USABILITY problems
The
...