SIST EN 62366-1:2015
(Main)Medical devices - Part 1: Application of usability engineering to medical devices
Medical devices - Part 1: Application of usability engineering to medical devices
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 CORRECT USE and USE ERRORS, i.e., NORMAL USE. 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 direct physical HAZARDS or loss or degradation of clinical functionality.
NOTE 2 Guidance on the application of USABILITY ENGINEERING to MEDICAL DEVICES is available in IEC 62366-22,
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.
Medizinprodukte - Anwendung der Gebrauchstauglichkeit auf Medizinprodukte
Dispositifs médicaux - Partie 1: Application de l'ingénierie de l'aptitude à l'utilisation aux dispositifs médicaux
L'IEC 62366-1:2015 spécifie un PROCESSUS permettant à un FABRICANT d'analyser, de spécifier, de développer et d'évaluer l'APTITUDE A l'UTILISATION d'un DISPOSITIF MEDICAL, concernant la SECURITE. Ce PROCESSUS D'INGENIERIE DE L'APTITUDE A L'UTILISATION (INGENIERIE DES FACTEURS HUMAINS) permet au FABRICANT d'évaluer et de réduire les RISQUES associés à une UTILISATION CORRECTE et à des ERREURS d'UTILISATION, c'est-à-dire une UTILISATION NORMALE. Il peut être utilisé pour identifier les RISQUES associés à une UTILISATION ANORMALE mais ne les évalue pas et ne les réduit pas. La première édition de l'IEC 62366-1, ainsi que la première édition de l'IEC 62366-2, annule et remplace la première édition de l'IEC 62366 parue en 2007 et son Amendement 1 (2014). La Partie 1 a été mise à jour afin d'inclure des concepts contemporains d'INGENIERIE DE L'APTITUDE A L'UTILISATION, tout en rationalisant le processus. Elle renforce aussi les liens avec l'ISO 14971:2007 et les méthodes connexes de GESTION DES RISQUES appliquées aux aspects relatifs à la sécurité des INTERFACES UTILISATEUR des DISPOSITIFS MEDICAUX. La Partie 2 contient des informations didactiques pour aider les fabricants à se conformer à la Partie 1 et fournit des descriptions plus détaillées des méthodes d'INGENIERIE DE L'APTITUDE A L'UTILISATION QUI PEUVENT ETRE APPLIQUEES D'UNE FAÇON PLUS GENERALE AUX DISPOSITIFS MEDICAUX et qui vont au-delà des aspects relatifs à la sécurité des INTERFACES UTILISATEUR des DISPOSITIFS MEDICAUX.
Medicinske naprave - 1. del: Izvedba tehnik uporabe pri medicinskih napravah
Ta del standarda IEC 62366 določa POSTOPEK, s pomočjo katerega PROIZVAJALEC analizira, določi, razvije in oceni UPORABNOST MEDICINSKE NAPRAVE, saj se nanaša na VARNOST. Ta POSTOPEK IZVEDBE TEHNIK UPORABE (NAČRTOVANJE ČLOVEŠKIH DEJAVNIKOV) omogoča PROIZVAJALCU, da oceni in blaži TVEGANJA, povezana z NEPRAVILNO UPORABO IN NAPAKAMI PRI UPORABI, tj. pri NORMALNI UPORABI. Uporablja se lahko za opredelitev, vendar ne ocenjuje ali blaži TVEGANJ, povezanih z NENORMALNO UPORABO.
OPOMBA 1: VARNOST je svoboda pred nesprejemljivim TVEGANJEM. Nesprejemljivo TVEGANJE lahko izhaja iz NAPAKE PRI UPORABI, kar lahko vodi v izpostavljenost neposrednim fizičnim NEVARNOSTIM ali izgubo ali degradacijo klinične uporabnosti.
OPOMBA 2: Navodila za izvedbo TEHNIK UPORABE za MEDICINSKE NAPRAVE so na voljo v standardu IEC 62366-22, ki ne obravnava samo VARNOSTI, ampak tudi vidike UPORABNOSTI, ki se ne nanašajo na VARNOST. Če je bil upoštevan POSTOPEK IZVEDBE TEHNIK UPORABE v tem mednarodnem standardu, se UPORABNOST MEDICINSKE NAPRAVE v zvezi z VARNOSTJO šteje za sprejemljivo, če ni OBJEKTIVNIH DOKAZOV o nasprotnem.
OPOMBA 3: Taki OBJEKTIVNI DOKAZI lahko posledično izvirajo iz POPROIZVODNEGA nadzora.
General Information
Relations
Related Packages
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN 62366-1:2015
01-september-2015
1DGRPHãþD
SIST EN 62366:2008
SIST EN 62366:2008/A1:2015
Medicinske naprave - 1. del: Izvedba tehnik uporabe pri medicinskih napravah
Medical devices - Part 1: Application of usability engineering to medical devices
Medizinprodukte - Anwendung der Gebrauchstauglichkeit auf Medizinprodukte
Dispositifs médicaux - Partie 1: Application de l'ingénierie de l'aptitude à l'utilisation aux
dispositifs médicaux
Ta slovenski standard je istoveten z: EN 62366-1:2015
ICS:
11.040.01 Medicinska oprema na Medical equipment in general
splošno
SIST EN 62366-1:2015 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN 62366-1:2015
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SIST EN 62366-1:2015
EUROPEAN STANDARD EN 62366-1
NORME EUROPÉENNE
EUROPÄISCHE NORM
April 2015
ICS 11.040
English Version
Medical devices - Part 1: Application of usability engineering to
medical devices
(IEC 62366-1:2015)
Dispositifs médicaux - Partie 1: Application de l'ingénierie Medizinprodukte - Anwendung der Gebrauchstauglichkeit
de l'aptitude à l'utilisation aux dispositifs médicaux auf Medizinprodukte
(IEC 62366-1:2015) (IEC 62366-1:2015)
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 Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung
CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2015 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
Ref. No. EN 62366-1:2015 E
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SIST EN 62366-1:2015
EN 62366-1:2015 - 2 -
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:
• latest date by which the document has (dop) 2015-12-31
to be implemented at national level by
publication of an identical national
standard or by endorsement
(dow) 2018-03-31
• latest date by which the national
standards conflicting with the
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 [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:
IEC 60601-1:2005 NOTE Harmonized as EN 60601-1:2006.
IEC 60601-1:2005/A1:2012 NOTE Harmonized as EN 60601-1:2006/A1:2013.
IEC 60601-1-6:2010 NOTE Harmonized as EN 60601-1-6:2010.
IEC 60601-1-6:2010/A1:2013 NOTE Harmonized as EN 60601-1-6:2010/A1:2013.
IEC 60601-1-8:2006 NOTE Harmonized as EN 60601-1-8:2007.
IEC 60601-1-8:2006/A1:2012 NOTE Harmonized as EN 60601-1-8:2007/A1:2013.
IEC 60601-1-11 NOTE Harmonized as EN 60601-1-11.
ISO 7010:2011 NOTE Harmonized as EN ISO 7010:2012.
ISO 9000:2005 NOTE Harmonized as EN ISO 9000:2005.
ISO 9001:2008 NOTE Harmonized as EN ISO 9001:2008.
ISO 9241-11:1998 NOTE Harmonized as EN ISO 9241-11:1998.
ISO 13485:2003 NOTE Harmonized as EN ISO 13485:2012.
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SIST EN 62366-1:2015
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Annex ZA
(normative)
Normative references to international publications
with their corresponding European publications
The following documents, in whole or in part, are normatively referenced in this document and are
indispensable for its application. For dated references, only the edition cited applies. For undated
references, the latest edition of the referenced document (including any amendments) applies.
NOTE 1 When 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 2007 Medical devices - Application of risk EN ISO 14971 2012
management to medical devices
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SIST EN 62366-1:2015
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SIST EN 62366-1:2015
IEC 62366-1
Edition 1.0 2015-02
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
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 ISBN 978-2-8322-2281-2
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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SIST EN 62366-1:2015
– 2 – IEC 62366-1:2015 IEC 2015
CONTENTS
FOREWORD . 4
INTRODUCTION . 6
1 * Scope . 7
2 Normative references . 7
3 Terms and definitions . 7
4 Principles . 12
4.1 General requirements . 12
4.1.1 * USABILITY ENGINEERING PROCESS . 12
4.1.2 * RISK CONTROL as it relates to USER INTERFACE design . 13
4.1.3 Information for SAFETY as it relates to USABILITY . 13
4.2 * USABILITY ENGINEERING FILE . 14
4.3 Tailoring of the USABILITY ENGINEERING effort . 14
5 * USABILITY ENGINEERING PROCESS . 14
5.1 * Prepare USE SPECIFICATION . 14
5.2 * Identify USER INTERFACE characteristics related to SAFETY and potential USE
ERRORS . 15
5.3 * Identify known or foreseeable HAZARDS and HAZARDOUS SITUATIONS . 15
5.4 * Identify and describe HAZARD-RELATED USE SCENARIOS . 15
5.5 * Select the HAZARD-RELATED USE SCENARIOS for SUMMATIVE EVALUATION . 16
5.6 * Establish USER INTERFACE SPECIFICATION . 16
5.7 * Establish USER INTERFACE EVALUATION plan . 16
5.7.1 General . 16
5.7.2 * FORMATIVE EVALUATION planning . 17
5.7.3 * SUMMATIVE EVALUATION planning . 17
5.8 * Perform USER INTERFACE design, implementation and FORMATIVE
EVALUATION . 18
5.9 * Perform SUMMATIVE EVALUATION of the USABILITY of the USER INTERFACE . 19
5.10 USER INTERFACE OF UNKNOWN PROVENANCE . 19
Annex A (informative) General guidance and rationale . 20
A.1 General guidance . 20
A.2 Rationale for requirements in particular clauses and subclauses . 20
ANNEX B (informative) Examples of possible HAZARDOUS SITUATIONS related to
USABILITY . 38
Annex C (normative) Evaluation of a USER INTERFACE OF UNKNOWN PROVENANCE (UOUP) . 41
C.1 General . 41
C.2 USABILITY ENGINEERING PROCESS for USER INTERFACE OF UNKNOWN
PROVENANCE . 41
C.2.1 * USE SPECIFICATION . 41
C.2.2 * Review of POST-PRODUCTION information . 42
C.2.3 HAZARDS and HAZARDOUS SITUATIONS related to USABILITY. 42
C.2.4 RISK CONTROL . 42
C.2.5 RESIDUAL RISK evaluation . 42
Annex D (informative) Types of MEDICAL DEVICE use, with examples . 43
Annex E (informative) Reference to the essential principles . 45
Bibliography . 46
Index of defined terms . 49
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SIST EN 62366-1:2015
IEC 62366-1:2015 IEC 2015 – 3 –
Figure 1 – Relationship of the types of use . 8
Figure A.1 – Model of USER-MEDICAL DEVICE interaction . 24
Figure A.2 – Relationship of TASKS and functions within a USE SCENARIO . 25
Figure A.3 – Relationship of TASKS and functions and USE ERROR within a HAZARD-
RELATED USE SCENARIO . 26
Figure A.4 – The relationship between the RISK MANAGEMENT PROCESS
(ISO 14971:2007) and the USABILITY ENGINEERING PROCESS (IEC 62366-1) . 32
Figure D.1 – Interrelationships between the different types of MEDICAL DEVICE use, with
examples . 44
Table B.1 – Glossary of relevant RISK MANAGEMENT terms . 38
Table B.2 – Examples of HARM due to RISK caused by USE ERROR(S) or poor USABILITY
(1 of 3) . 38
Table E.1 – Correspondence between this document and the essential principles . 45
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INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL DEVICES –
Part 1: Application of usability engineering to medical devices
FOREWORD
1) 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.
2) 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.
3) 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.
4) 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.
5) 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.
6) All users should ensure that they have the latest edition of this publication.
7) 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.
8) 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.
9) 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 14971:2007 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 manufactures in complying with Part 1, as well as
offering more detailed descriptions of USABILITY ENGINEERING methods that can be applied
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SIST EN 62366-1:2015
IEC 62366-1:2015 IEC 2015 – 5 –
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:
FDIS Report on voting
62A/977/FDIS 62A/988/RVD
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 IN CLAUSE 3 OR 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.
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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.4.
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
1
(IEC 62366-2 ) 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 functionality.
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 benefits of
a MEDICAL DEVICE that not only is safe to use but also offers superior USABILITY.
—————————
1
IEC 62366-2, Medical devices – Part 2: Guidance on the application of usability engineering to medical devices
(in preparation).
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SIST EN 62366-1:2015
IEC 62366-1:2015 IEC 2015 – 7 –
MEDICAL DEVICES –
Part 1: Application of usability engineering to medical devices
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 CORRECT USE and USE ERRORS, i.e., NORMAL USE. 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 direct physical HAZARDS or loss or degradation of clinical functionality.
2
NOTE 2 Guidance on the application of USABILITY ENGINEERING to MEDICAL DEVICES is available in IEC 62366-2 ,
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
The following documents, in whole or in part, are normatively referenced in this document and
are indispensable for its application. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any
amendments) applies.
NOTE 1 The way in which these referenced documents are cited in normative requirements determines the extent
(in whole or in part) to which they apply.
NOTE 2 Informative references are listed in the bibliography beginning on page 46.
ISO 14971:2007, Medical devices – Application of risk management to medical devices
3 Terms and definitions
For the purpose of this document, the terms and definitions given in ISO 14971:2007 and the
following apply.
NOTE An index of defined terms is found beginning on page 49.
3.1
* ABNORMAL USE
conscious, intentional act or intentional omission of an act that is counter to or violates
NORMAL USE and is also beyond any further reasonable means of USER INTERFACE-related RISK
CONTROL by the MANUFACTURER
EXAMPLES Reckless use or sabotage or intentional disregard of information for SAFETY are such acts.
—————————
2
IEC 62366-2, Medical devices – Part 2: Guidance on the application of usability engineering to medical devices
(in preparation).
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Note 1 to entry See also 4.1.3.
Note 2 to entry: An intended but erroneous action that is not ABNORMAL USE is considered a type of USE ERROR.
Note 3 to entry: ABNORMAL USE does not relieve the MANUFACTURER from considering non-USER INTERFACE-related
means of RISK CONTROL.
Note 4 to entry: Figure 1 shows the relationships of the types of use.
IEC
NOTE Figure D.1 contains additional detail
Figure 1 – Relationship of the types of use
3.2
ACCOMPANYING DOCUMENTATION
materials accompanying a MEDICAL DEVICE and containing information for the USER or those
accountable for the installation, use and maintenance 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.
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 14971:2007, 2.1, modified – The term has been changed to refer to
‘documentation’ rather than ‘document’, and in the definition ‘document’ has been replaced by
‘material’, ‘OPERATOR’ has been deleted and notes to entry have been added.]
3.3
CORRECT USE
NORMAL USE without USE ERROR
Note 1 to entry: Deviation from instructions for use is only considered USE ERROR if it leads to a MEDICAL DEVICE
response that is different than intended by the MANUFACTURER or expected by the USER.
Note 2 to entry: Figure 1 shows the relationships of the types of use.
3.4
EFFECTIVENESS
accuracy and completeness with which USERS achieve specified goals
Note 1 to entry: This is a different concept than 'clinical effectiveness'.
[SOURCE: ISO 9241-11:1998, 3.2, modified – Added the note to entry.]
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SIST EN 62366-1:2015
IEC 62366-1:2015 IEC 2015 – 9 –
3.5
* EFFICIENCY
resources expended in relation to EFFECTIVENESS
[SOURCE: ISO 9241-11:1988, 3.3, modified – the term "EFFECTIVENESS" has replaced the
original phrase, which here constitutes the definition of 3.4 EFFECTIVENESS.
3.6
EXPECTED SERVICE LIFE
time period specified by the MANUFACTURER during which the MEDICAL DEVICE is expected to
remain safe for use (i.e. maintain basic SAFETY and essential performance)
Note 1 to entry: Maintenance can be necessary during the EXPECTED SERVICE LIFE.
[SOURCE: IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012, 3.28, modified – In the
definition, ‘ME EQUIPMENT and ME SYSTEM’ have been replaced with ‘MEDICAL DEVICE’.]
3.7
FORMATIVE EVALUATION
USER INTERFACE EVALUATION conducted with the intent to explore USER INTERFACE design
strengths, weaknesses, and unanticipated USE ERRORS
Note 1 to entry: FORMATIVE EVALUATION is generally performed iteratively throughout the design and development
PROCESS, but prior to SUMMATIVE EVALUATION, to guide USER INTERFACE design as necessary.
3.8
HAZARD-RELATED USE SCENARIO
USE SCENARIO that could lead to a HAZARDOUS SITUATION or HARM
Note 1 to entry: A HAZARD-RELATED USE SCENARIO can often be linked to a potential USE ERROR.
Note 2 to entry: A HAZARD-RELATED USE SCENARIO is not related to a failure of the MEDICAL DEVICE, unle
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