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IEC 62366-1
Edition 1.0 2020-06
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
AMENDMENT 1
AMENDEMENT 1
Medical devices –
Part 1: Application of usability engineering to medical devices
Dispositifs médicaux –
Partie 1: Application de l'ingénierie de l'aptitude à l'utilisation aux dispositifs
médicaux
IEC 62366-1:2015-02/AMD1:2020-06(en-fr)
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IEC 62366-1
Edition 1.0 2020-06
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
A MENDMENT 1
AM ENDEMENT 1
Medical devices –
Part 1: Application of usability engineering to medical devices
Dispositifs médicaux –
Partie 1: Application de l'ingénierie de l'aptitude à l'utilisation aux dispositifs
médicaux
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 11.040.01 ISBN 978-2-8322-8384-4
– 2 – IEC 62366-1:2015/AMD1:2020
© IEC 2020
FOREWORD
This amendment has been prepared by subcommittee 62A: Common aspects of electrical
equipment used in medical practice, of IEC technical committee 62: Electrical equipment in
medical practice, and ISO technical committee 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/1386/FDIS 62A/1397/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.
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• withdrawn,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.
_____________
FOREWORD
In the fourth paragraph, replace “ISO 14971:2007” with “ISO 14971:2019”, format “medical
device user interfaces” in small caps and replace “manufactures” with “MANUFACTURERS” to
correct the spelling and the format.
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
MANUFACTURERS in
IEC TR 62366-2 is available, which contains tutorial information to assist
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.
© IEC 2020
INTRODUCTION
Replace, in the second paragraph, “Figure A.4” with “Figure A.5”.
Replace, in the NOTE, “functionality” with “performance”.
Replace, in the last paragraph, “benefits” with “advantages”.
Replace the existing footnote 1 with the following:
IEC TR 62366-2:2016, Medical devices – Part 2: Guidance on the application of usability engineering to medical
devices.
1 * Scope
In the second sentence, replace “with CORRECT USE and USE ERRORS, i.e., NORMAL USE” with
“with NORMAL USE, i.e., CORRECT USE and USE ERROR”.
Replace NOTE 1 with the following:
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.
Replace the existing footnote 2 with the following:
IEC TR 62366-2:2016, Medical devices – Part 2: Guidance on the application of usability engineering to medical
devices.
2 Normative references
Replace “ISO 14971:2007” with “ISO 14971:2019”.
3 Terms and definitions
Replace, in the first paragraph, “ISO 14971:2007” with “ISO 14971:2019”.
3.1
ABNORMAL USE
*
Replace, in the existing definition and its example, “intentional” with “deliberate” in 3 places.
3.2
ACCOMPANYING DOCUMENTATION
Replace the existing definition, notes to entry and source with the following:
3.2
ACCOMPANYING DOCUMENTATION
materials accompanying a MEDICAL DEVICE and containing information for the USER or those
accountable for the installation, use, maintenance, decommissioning and disposal of the
MEDICAL DEVICE, particularly regarding safe use
Note 1 to entry: The ACCOMPANYING DOCUMENTATION can consist of the instructions for use, technical description,
installation manual, quick reference guide, etc.
Note 2 to entry: ACCOMPANYING DOCUMENTATION is not necessarily a written or printed document but could involve
auditory, visual, or tactile materials and multiple media types.
– 4 – IEC 62366-1:2015/AMD1:2020
© IEC 2020
Note 3 to entry: MEDICAL DEVICES that can be used safely without instructions for use are exempted from having
instructions for use by some authorities with jurisdiction.
[SOURCE: ISO 14971:2019, 3.1, modified – Note 3 to entry has been added.]
3.20
USE ENVIRONMENT
Add, in Note 1 to entry, the following second sentence:
Social attributes such as team versus individual, chaotic versus calm, stress level and length of shift can also play
a role.
3.23
* USE SPECIFICATION
Replace, in Note 3 to entry, “ISO 14971:2007” with “ISO 14971:2019”.
3.25
USER GROUP
Replace the definition with the following:
subset of USERS who are differentiated from other USERS by factors that are likely to influence
their interactions with the MEDICAL DEVICE
NOTE 1 to entry: Attributes of USER GROUPS can include age, culture, expertise.
3.29
USER PROFILE
Replace the existing definition with the following:
summary of the mental, physical and demographic traits of a USER GROUP, as well as
characteristics, such as knowledge, skills and abilities, which can have a bearing on design
decisions
4.1.1 * USABILITY ENGINEERING PROCESS
Replace, in the third paragraph, “ISO 13485:2003” with “ISO 13485:2016”.
Replace, in NOTE 1, “ISO 13485:2003” with “ISO 13485:2016”.
Replace, in the fourth paragraph, “ISO 14971:2007” with “ISO 14971:2019” and “Figure A.4”
with “Figure A.5”.
Replace, in the fifth paragraph, “Figure A.4” with “Figure A.5” and “carried out” with “carried
out iteratively or”.
4.1.2 * RISK CONTROL as it relates to USER INTERFACE design
Replace the first paragraph and list items a) to c) with the following:
To reduce use-related RISK, the MANUFACTURER shall use one or more of the following options,
in the priority listed (as required by ISO 14971:2019, 7.1):
a) inherently safe design and manufacture;
b) protective measures in the MEDICAL DEVICE itself or in the manufacturing PROCESS; and
c) information for SAFETY and, where appropriate, training to USERS.
© IEC 2020
4.1.3 Information for SAFETY as it relates to USABILITY
Replace, in the second paragraph, “intentional” with “deliberate” in 2 places.
4.3 Tailoring of the USABILITY ENGINEERING effort
Delete the compliance check.
5.1 * Prepare USE SPECIFICATION
Replace the fifth dash with:
– * intended USE ENVIRONMENT; and
5.2 * Identify USER INTERFACE characteristics related to SAFETY and potential USE ERRORS
Replace, in the first paragraph, “ISO 14971:2007, 4.2” with “ISO 14971:2019, 5.3”.
Replace the last sentence of the first paragraph with the following:
This identification shall include consideration of the PRIMARY OPERATING FUNCTIONS if they are
MEDICAL DEVICE SAFETY standards.
provided in applicable product-specific
Replace, in NOTE 1, “ISO 14971:2007, C.2.29 to C.2.34” with “ISO/TR 24971:— , A.2.31 to
A.2.37”.
Insert the following footnote:
Under preparation. Stage at the time of circulation: ISO /TR APUB 24971:2020.
Replace the paragraph preceding the compliance check with the following:
The results of this identification of characteristics related to SAFETY and potential USE ERRORS
shall be stored in the USABILITY ENGINEERING FILE.
5.3 * Identify known or foreseeable HAZARDS and HAZARDOUS SITUATIONS
Replace the last sentence of the first paragraph with the following:
This identification shall be conducted as part of a RISK ANALYSIS performed according to
ISO 14971:2019, 5.4.
5.5 * Select the HAZARD-RELATED USE SCENARIOS for SUMMATIVE EVALUATION
Replace the text of the subclause with the following:
The MANUFACTURER shall select the HAZARD-RELATED USE SCENARIOS to be included in the
SUMMATIVE EVALUATION.
The MANUFACTURER shall select:
– all HAZARD-RELATED USE SCENARIOS;
– 6 – IEC 62366-1:2015/AMD1:2020
© IEC 2020
– a subset of the HAZARD-RELATED USE SCENARIOS based on the SEVERITY of the potential
HARM that could be caused by USE ERROR (e.g. for which medical intervention would be
needed); or
NOTE 1 The SEVERITY of HARM is determined in ISO 14971:2019, 5.5.
– a subset of the HAZARD-RELATED USE SCENARIOS based on the SEVERITY of the potential
HARM and based on other circumstances specific to the MEDICAL DEVICE and the
MANUFACTURER.
NOTE 2 Examples of selection schemes are given in Annex A, 5.5, and IEC TR 62366-2.
A summary of any sele
...