Medical devices - Part 1: Application of usability engineering to medical devices (IEC 62366-1:2015/A1:2020)

2019-04-04-JO-: link to legislation to the MDD 93/42/EEC and mandate M/432 removed following CLC/BT decision D162/C076

Medizinprodukte - Teil 1: Anwendung der Gebrauchstauglichkeit auf Medizinprodukte (IEC 62366-1:2015/A1:2020)

Dispositifs médicaux - Partie 1: Application de l'ingénierie de l'aptitude à l'utilisation aux dispositifs médicaux (IEC 62366-1:2015/A1:2020)

Medicinske naprave - 1. del: Izvedba tehnik uporabe pri medicinskih napravah - Dopolnilo A1 (IEC 62366-1:2015/A1:2020)

General Information

Status
Published
Publication Date
03-Sep-2020
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
12-Aug-2020
Due Date
17-Oct-2020
Completion Date
04-Sep-2020

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SLOVENSKI STANDARD
SIST EN 62366-1:2015/A1:2020
01-november-2020
Medicinske naprave - 1. del: Izvedba tehnik uporabe pri medicinskih napravah -
Dopolnilo A1 (IEC 62366-1:2015/A1:2020)

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

62366-1:2015/A1:2020)

Medizinprodukte - Teil 1: Anwendung der Gebrauchstauglichkeit auf Medizinprodukte

(IEC 62366-1:2015/A1:2020)

Dispositifs médicaux - Partie 1: Application de l'ingénierie de l'aptitude à l'utilisation aux

dispositifs médicaux (IEC 62366-1:2015/A1:2020)
Ta slovenski standard je istoveten z: EN 62366-1:2015/A1:2020
ICS:
11.040.01 Medicinska oprema na Medical equipment in general
splošno
SIST EN 62366-1:2015/A1:2020 en

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
SIST EN 62366-1:2015/A1:2020
---------------------- Page: 2 ----------------------
SIST EN 62366-1:2015/A1:2020
EUROPEAN STANDARD EN 62366-1:2015/A1
NORME EUROPÉENNE
EUROPÄISCHE NORM
August 2020
ICS 11.040
English Version
Medical devices - Part 1: Application of usability engineering to
medical devices
(IEC 62366-1:2015/A1:2020)

Dispositifs médicaux - Partie 1: Application de l'ingénierie Medizinprodukte - Teil 1: Anwendung der

de l'aptitude à l'utilisation aux dispositifs médicaux Gebrauchstauglichkeit auf Medizinprodukte

(IEC 62366-1:2015/A1:2020) (IEC 62366-1:2015/A1:2020)

This amendment A1 modifies the European Standard EN 62366-1:2015; it was approved by CENELEC on 2020-07-22. CENELEC

members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this amendment 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 amendment 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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the

Netherlands, Norway, Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,

Turkey and the United Kingdom.
European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels

© 2020 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.

Ref. No. EN 62366-1:2015/A1:2020 E
---------------------- Page: 3 ----------------------
SIST EN 62366-1:2015/A1:2020
EN 62366-1:2015/A1:2020 (E)
European foreword

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:

• latest date by which the document has to be implemented at national (dop) 2021-04-22

level by publication of an identical national standard or by endorsement

• latest date by which the national standards conflicting with the (dow) 2023-07-22

document have to be withdrawn

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:
IEC 60601-1-11:2015 NOTE Harmonized as EN 60601-1-11:2015 (not modified)
ISO 9000:2015 NOTE Harmonized as EN ISO 9000:2015 (not modified)
ISO 9001:2015 NOTE Harmonized as EN ISO 9001:2015 (not modified)
ISO 13485:2016 NOTE Harmonized as EN ISO 13485:2016 (not modified)
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SIST EN 62366-1:2015/A1:2020
EN 62366-1:2015/A1:2020 (E)
Annex ZA
(normative)
Normative references to international publications
with their corresponding European publications

The following documents are referred to in the text in such a way that some or all of their content

constitutes requirements of this document. For dated references, only the edition cited applies. For

undated references, the latest edition of the referenced document (including any amendments)

applies.

NOTE 1 Where an International Publication has been modified by common modifications, indicated by (mod), the relevant

EN/HD applies.

NOTE 2 Up-to-date information on the latest versions of the European Standards listed in this annex is available here:

www.cenelec.eu.
Publication Year Title EN/HD Year
ISO 14971 2019 Medical devices – Application of risk EN ISO 14971 2019
management to medical devices
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SIST EN 62366-1:2015/A1:2020
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SIST EN 62366-1:2015/A1:2020
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

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.

---------------------- Page: 7 ----------------------
SIST EN 62366-1:2015/A1:2020
– 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.
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SIST EN 62366-1:2015/A1:2020
IEC 62366-1:2015/AMD1:2020 – 3 –
© 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.
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SIST EN 62366-1:2015/A1:2020
– 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.
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SIST EN 62366-1:2015/A1:2020
IEC 62366-1:2015/AMD1:2020 – 5 –
© 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;
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SIST EN 62366-1:2015/A1:2020
– 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 selection scheme, the rationale for its use and the results of applying it shall

be stored in the USABILITY ENGINEERING FILE.
Compliance is checked by inspection of the USABILITY ENGINEERING FILE.
5.7.1 General
Delete, in the first sentence, “SPECIFICATION”.

Replace the first dash under list item b), including Examples 1 and 2, with the following:

– document which USER GROUPS are intended to be included in the test;

EXAMPLE 1 In a FORMATIVE EVALUATION, clinical personnel who are employees of the MANUFACTURER are

used to represent a nurse-USER GROUP.

EXAMPLE 2 In a SUMMATIVE EVALUATION, a panel of practicing intensive care nurses is used to represent

a critical care nursing USER GROUP.
Multiple USER PROFILES may be combined into a USER GROUP for the purposes of a
USABILITY TEST;
Add, in the penultimate dash under list item b) “and” after the semicolon.
Replace, in NOTE 3, “scaling” with “tailoring”.
5.7.3 * SUMMATIVE EVALUATION planning
Replace list item e) with the following:
e) * for a USABILITY TEST,

– how the characteristics of the test participants are representative of the intended USER

PROFILES;

– justifying how the test participants are grouped into distinct USER GROUPS for the

purpose of determining the number of test participants;

– the test environment and conditions of use and a rationale for how they are adequately

representative of the intended USE ENVIRONMENT;
– the definition of CORRECT USE for each HAZARD-RELATED USE SCENARIO; and

– the method of collecting data during the USABILITY TEST for the subsequent analysis of

observed USE ERRORS and use difficulties.
Delete the existing NOTE 5.
5.8 * Perform USER INTERFACE design, implementation and FORMATIVE EVALUATION
Replace, in NOTE 1, “ISO 14971:2007, Subclause 6.6” with “ISO 14971:2019, 7.5”.
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SIST EN 62366-1:2015/A1:2020
IEC 62366-1:2015/AMD1:2020 – 7 –
© IEC 2020
5.9 * Perform SUMMATIVE EVALUATION of the USABILITY of the USER INTERFACE
Replace the second paragraph with the following:

The MANUFACTURER shall analyse the data of the SUMMATIVE EVALUATION and shall identify all

USE ERRORS and use difficulties that occurred. If a USE ERROR or use difficulty can lead to a

HAZARDOUS SITUATION, the root cause of any such USE ERROR or use difficulty shall be

determined. The root causes should be determined based on methods including observations

of USER performance as well as subjective comments from the USER.

NOTE 1 A use difficulty where a USER almost commits a USE ERROR while performing a TASK, but recovers in time

to avoid making the USE ERROR is sometimes called a “close call”.
Renumber NOTES 1 to 5 as 2 to 6.
Replace item i), without modifying the note, with the following:
i) document why improvement is not necessary or not practicable;
Replace, in NOTE 3, “ISO 14971:2007, 6.2” with “ISO 14971:2019, 7.1 and
ISO/TR 24971:— , Annex C”.
Insert the following footnote:
Under preparation. Stage at the time of circulation: ISO/TR APUB 24971:2020.
Replace item iii) with the following:
iii) evaluate the RESIDUAL RISK according to ISO 14971:2019, 7.3.
Replace, in NOTE 4, “ISO 14971:2007, Subclause 6.6” with “ISO 14971:2019, 7.5”.
Replace, in NOTE 5, “ISO 14971:2007, Clause 7” with “ISO 14971:2019, Clause 8”.

Replace, in the compliance check, "ISO 14971:2007, 6.4” with “ISO 14971:2019, 7.3”.

A.2 Rationale for requirements in particular clauses and subclauses
Clause 1 – Scope
In the sixth paragraph, set benefits in small caps in 2 places.
Replace, in the last paragraph, “benefits” with “advantages”.
Definition 3.1 – ABNORMAL USE
Replace, in the third dash, “RISK benefit” with “BENEFIT-RISK”.
Replace, in Example 2, “RISK/benefit” with “BENEFIT and RISK”.

Replace, in the first sentence of the last paragraph, “inaction” with “lack of USER action”.

Definition 3.11 – PRIMARY OPERATING FUNCTION
Replace the entire paragraph with the following:

For the purposes of this document, a PRIMARY OPERATING FUNCTION is a function that is directly

related to the SAFETY of the MEDICAL DEVICE. PRIMARY OPERATING FUNCTIONS are identified in

some product-specific MEDICAL DEVICE SAFETY standards. These standards require those

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SIST EN 62366-1:2015/A1:2020
– 8 – IEC 62366-1:2015/AMD1:2020
© IEC 2020

identified PRIMARY OPERATING FUNCTIONS to be an input to the USABILITY ENGINEERING PROCESS.

This document does not require any further identification of PRIMARY OPERATING FUNCTIONS

because this document requires the identification, description and evaluation of HAZARD-

RELATED USE SCENARIOS. However, TASKS to be performed within a HAZARD-RELATED USE

SCENARIO might be related to a function that has been identified as a PRIMARY OPERATING

FUNCTION
Definition 3.17 – USABILITY ENGINEERING or HUMAN FACTORS ENGINEERING

Delete the second sentence of the first paragraph and combine the first and second

paragraphs.
USE ERROR
Definition 3.21 –
Replace the first and second sentences of the first paragraph with:

USE ERRORS often can be an indication of USER INTERFACE design flaws that affect the

interaction of a USER with a MEDICAL DEVICE.
Definition 3.22 – USE SCENARIO
Add the following sentence to the end of the second paragraph:

A TASK in a HAZARD-RELATED USE SCENARIO, in which a USE ERROR can lead to significant HARM,

can be thought of as a 'critical task' [48] [49].
Clause 5 – USABILITY ENGINEERING PROCESS

Replace the entire rationale for Clause 5 including Figure A.4 with the following:

The purpose of the USABILITY ENGINEERING PROCESS, as described in this document, is to

provide use-related SAFETY of the MEDICAL DEVICE for the PATIENT, USER and others. To

USABILITY ENGINEERING PROCESS mitigates RISK caused by USER
achieve this purpose, the
interaction problems associated with NORMAL USE, such as USE ERROR.

Figure A.4 illustrates the types of use as described in this document and their relationship to

the concept of “reasonably foreseeable misuse” in ISO 14971.
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SIST EN 62366-1:2015/A1:2020
IEC 62366-1:2015/AMD1:2020 – 9 –
© IEC 2020
Figure A.4 – Types of use as described in this document and their relationship
to the concept of “reasonably foreseeable misuse” in ISO 14971

OBJECTIVE EVIDENCE to support the determination that use-related RESIDUAL RISK has been

reduced to acceptable levels is generated by conducting SUMMATIVE EVALUATION of the

USABILITY of the USER INTERFACE.

To establish criteria for the acceptability of RESIDUAL RISKS related to USABILITY, the

MANUFACTURER considers relevant available data (e.g., the state of technology, experience

with similar MEDICAL DEVICES, POST-PRODUCTION surveillance reports). The MANUFACTURER can

RESIDUAL RISK
apply these criteria according to ISO 14971, which additionally considers
relative to the BENEFIT of the MEDICAL DEVICE.

A comprehensive RISK MANAGEMENT PROCESS, such as that defined in ISO 14971, requires that

a MANUFACTURER establish, implement, document and maintain a PROCESS for identifying

HAZARDS and HAZARDOUS SITUATIONS associated with a MEDICAL DEVICE, estimating and

evaluating the associated RISKS, controlling those RISKS, and monitoring how effective those

LIFE CYCLE. Such a PROCESS includes the following elements:
controls are throughout the
– RISK ANALYSIS;
– RISK EVALUATION;
– RISK CONTROL; and
– production and POST-PRODUCTION activities.

When applying a comprehensive RISK MANAGEMENT PROCESS to the USER INTERFACE, estimating

the RISK associated with each USE ERROR can be problematic, particularly because no

validated techniques are known to exist to predict, in advance, the likelihood of a person

USE ERROR. However, this document provides a PROCESS that a MANUFACTURER
committing a

can use to analyse, specify, design and evaluate the USABILITY of a MEDICAL DEVICE.

Implementing this PROCESS permits the MANUFACTURER to address the unpredictability of a

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SIST EN 62366-1:2015/A1:2020
– 10 – IEC 62366-1:2015/AMD1:2020
© IEC 2020

USER and minimize USE ERROR. This PROCESS helps the MANUFACTURER accomplish these

objectives by:
a) discovering HAZARDS and HAZARDOUS SITUATIONS related to the USER INTERFACE;

b) designing and implementing measures to control the RISKS related to the USER INTERFACE;

and
c) evaluating that these RISK CONTROL measures are effective in reducing RISK.

Other advantages of the USABILITY ENGINEERING PROCESS can include improved customer

satisfaction, but these aspects are beyond the scope of this document.

Figure A.5 provides an overview of relationship and interactions between the RISK

in ISO 14971 and the USABILITY ENGINEERING PROCESS of this document.
MANAGEMENT PROCESS

RISK MANAGEMENT is a decision-making PROCESS for determining acceptable RISK whereas

USABILITY ENGINEERING is a design and development PROCESS for the USER INTERFACE to

reduce the possibility of USE ERRORS that could result in HARM.

When the MANUFACTURER is identifying the characteristics related to SAFETY of the MEDICAL

DEVICE in accordance with the requirements of ISO 14971:2019, 5.3, the USABILITY
PROCESS can provide the detail necessary (see 5.2) to accomplish this step for
ENGINEERING
the USER INTERFACE of the MEDICAL DEVICE.

Further, when the MANUFACTURER is compiling a list of known or foreseeable HAZARDS and

HAZARDOUS SITUATIONS associated with the MEDICAL DEVICE in accordance with the

requirements of ISO 14971:2019, 5.4, the USABILITY ENGINEERING PROCESS provides a list of

items that are required to be considered (see 5.3) in order to accomplish this step for the

USER INTERFACE of the MEDICAL DEVICE.

ISO 14971 requires that RISKS associated with each of the identified HAZARDOUS SITUATIONS be

estimated (ISO 14971:2019, 5.5), and evaluated (ISO 14971:2019, Clause 6). If a RISK is not

acceptable according to the MANUFACTURER'S RISK acceptability criteria, the MANUFACTURER is

required to identify RISK CONTROL measure(s) that are appropriate for reducing the RISK(S) to

an acceptable level (ISO 14971:2019, 7.1). The MANUFACTURER is then required to implement

RISK CONTROL measures and verify that they are effective in reducing the RISK to
the identified
an acceptable level (ISO 14971:2019, 7.2).
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SIST EN 62366-1:2015/A1:2020
IEC 62366-1:2015/AMD1:2020 – 11 –
© IEC 2020

A, B, C, D, E and F represent information flow between the two PROCESSES. The heavy solid lines (B, C, D and F)

represent information flow required by this document. New problems identified should be interpreted to mean new

HAZARDS, HAZARDOUS SITUATIONS or HAZARD-RELATED USE SCENARIOS discovered or implemented RISK CONTROL is

ineffective.

New problems identified should be interpreted to mean new USE ERRORS, HAZARDS, HAZARDOUS SITUATIONS, or

HAZARD-RELATED USE SCENARIOS have been identified.
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SIST EN 62366-1:2015/A1:2020
– 12 – IEC 62366-1:2015/AMD1:2020
© IEC 2020
Key
A USE SPECIFICATION is an input to ISO 14971:2019, 5.2
B Identified USER INTERFACE characteristics related to SAFETY (see 5.2)
C Identified foreseeable HAZARD and HAZARDOUS SITUATIONS (see 5.3).

D Identified sequences of events leading to HAZARDOUS SITUATIONS from ISO 14971:2019, 5.4 are an input to

determining HAZARD-RELATED USE SCENARIOS (see 5.4).

E The SEVERITY of HARM as determined in ISO 14971:2019, 5.5 is an input to identifying and describing HAZARD-

RELATED USE SCENARIOS.

F The SUMMATIVE EVALUATION (see 5.9) produces OBJECTIVE EVIDENCE and data for determining and evaluating

RESIDUAL RISK related to use in ISO 14971:2019, 7.3.

Figure A.5 – The relationship between the RISK MANAGEMENT PROCESS (ISO 14971:2019)

and the USABILITY ENGINEERING PROCESS (IEC 62366-1)

The USABILITY ENGINEERING PROCESS requires that all known or foreseeable HAZARD-RELATED

USE SCENARIOS (see 5.4) are identified and described prior to selecting the HAZARD-RELATED

USE SCENARIOS (see 5.5) that are used in preparing the USER INTERFACE EVALUATION plan. In

RISK CONTROL options related to use are identified during the development of
this document,

the USER INTERFACE SPECIFICATION with testable requirements (see 5.6). The HAZARD-RELATED

USE SCENARIOS, the RISK CONTROL measures and the USER INTERFACE EVALUATION plan are

iteratively updated based on the results from FORMATIVE EVALUATIONS and from the other parts

of product realization PROCESS, as appropriate.

Both the FORMATIVE EVALUATION and the SUMMATIVE EVALUATION of the implemented USER

are planned in the USER INTERFACE EVALUATION plan (see 5.7). FORMATIVE
INTERFACE

EVALUATION is carried out during USER INTERFACE design and implementation (see 5.8) to

explore the USER INTERFACE, identify the need for improvement or to confirm adequacy of the

USER INTERFACE. For each selected HAZARD-RELATED USE SCENARIO, the implemented USER

INTERFACE is subject to SUMMATIVE EVALUATION (see 5.9) to produce OBJECTIVE EVIDENCE that

use-related RESIDUAL RISK has been reduced to acceptable levels. These steps achieve the

same objective as 5.5 through 7.2 of ISO 14971:2019.
Subclause 5.1 – Prepare USE SPECIFICATION
Replace, in the first sentence, “standard” with “document”.
Replace, in the USE ENVIRONMENT subheading, “USE ENVIRONMENT” with “intended USE
ENVIRONMENT”.

Subclause 5.2 – Identify USER INTERFACE characteristics related to SAFETY and potential

USE ERRORS

Replace, in the first paragraph, “ISO 14971:2007, C.2.1” with “ISO/TR 24971:— , A.2.1”.

Replace, in list item a), “ISO 14971:2007, C.2.9” with “ISO/TR 24971:—, A.2.9”.

Replace, in list item b), “ISO 14971:2007, C.2.12” with “ISO/TR 24971:—, A.2.12”.

Replace, in list item c), “ISO 14971:2007, C.2.26” with “ISO/TR 24971:—, A.2.28” and

“ISO 14971:2007, C.2.27” with “ISO/TR 24971:2019, A.2.29”.

Replace, in list item d), replace “ISO 14971:2007, C.2.29” with “ISO/TR 24971:—, A.2.31”.

Insert the following footnote:
Under preparation. Stage at the time of circulation: ISO/TR APUB 24971:2020.
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SIST EN 62366-1:2015/A1:2020
IEC 62366-1:2015/AMD1:2020 –
...

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