Amendment 2 - Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability

Amendement 2 - Appareils électromédicaux - Partie 1-6 : exigences générales pour la sécurité de base et les performances essentielles - Norme collatérale : aptitude à l'utilisation

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Published
Publication Date
21-Jul-2020
Current Stage
PPUB - Publication issued
Completion Date
22-Jul-2020
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IEC 60601-1-6:2010/AMD2:2020 - Amendment 2 - Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
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IEC 60601-1-6
Edition 3.0 2020-07
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
A MENDMENT 2
AM ENDEMENT 2
Medical electrical equipment –
Part 1-6: General requirements for basic safety and essential performance –
Collateral standard: Usability
Appareils électromédicaux –
Partie 1-6: Exigences générales pour la sécurité de base et les performances
essentielles – Norme collatérale: Aptitude à l'utilisation
IEC 60601-1-6:2010-01/AMD2:2020-07(en-fr)
---------------------- Page: 1 ----------------------
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---------------------- Page: 2 ----------------------
IEC 60601-1-6
Edition 3.0 2020-07
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
A MENDMENT 2
AM ENDEMENT 2
Medical electrical equipment –
Part 1-6: General requirements for basic safety and essential performance –
Collateral standard: Usability
Appareils électromédicaux –
Partie 1-6: Exigences générales pour la sécurité de base et les performances
essentielles – Norme collatérale: Aptitude à l'utilisation
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 11.040.01 ISBN 978-2-8322-8628-9

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.

® Registered trademark of the International Electrotechnical Commission
Marque déposée de la Commission Electrotechnique Internationale
---------------------- Page: 3 ----------------------
– 2 – IEC 60601-1-6:2010/AMD2:2020
© 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.
The text of this amendment is based on the following documents:
FDIS Report on voting
62A/1391/FDIS 62A/1406/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.

NOTE The attention of users of this document 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.

_____________
---------------------- Page: 4 ----------------------
IEC 60601-1-6:2010/AMD2:2020 – 3 –
© IEC 2020
INTRODUCTION TO AMENDMENT 2

The third edition of IEC 60601-1-6 was published in 2010 and amended in 2013. Since the

publication of IEC 60601-1-6:2010+A1:2013, the IEC Subcommittee (SC) 62A Secretariat has

been collecting issues from a variety of sources including comments from National Committees.

At the November 2015 meeting of IEC/SC 62A in Kobe, Japan, the subcommittee initiated a

process to identify high-priority issues that need to be considered in an amendment and should

not wait until the fourth edition of IEC 60601-1-6, which is presently targeted for publication

sometime after 2024.

Those issues selected for inclusion on the final "short list" to be addressed in Amendment 2

were those approved by a 2/3 majority of the National Committees present and voting at the

Frankfurt meeting of SC 62A. At the meeting held on 10 October 2016, nine items were

presented to the National Committees present. All nine items received the required 2/3 majority

of the National Committees present and voting and have been included in the "short list" for

consideration in preparing Amendment 2. All remaining issues have been placed on a "long list"

for consideration in the fourth edition of IEC 60601-1-6.

The "short list" of issues was documented in the design specification for Amendment 2. Because

these issues are closely related to the application of IEC 62366-1 to MEDICAL ELECTRICAL

EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS, the work was assigned to IEC/SC 62A-

ISO/TC 210 Joint Working Group (JWG) 4. JWG 4 was directed to consider each issue

described in Clause 6 of the design specification and develop an appropriate solution for the

identified problem. That final solution in this amendment can encompass any technical solution

proposed by the author of the issue or it can involve a different solution developed by the expert

group. The expert group can also have recommended that no change to the document was

justified by the problem statement.

This amendment updates the references from the now obsolete IEC 62366:2007 to the current

USABILITY ENGINEERING PROCESS standard, IEC 62366-1:2015+A1:2020.

Because this is an amendment to IEC 60601-1-6:2010, the style in force at the time of

publication of IEC 60601-1-6 has been applied to this amendment. The style specified in

ISO/IEC Directives Part 2:2018 has only been applied when implementing the new style

guidance would not result in additional editorial changes. For example, references to

amendments take the following form: "IEC 60601-1:2005+A1:2012+A2:2020".

Users of this document should note that when constructing the dated references to specific

elements in a standard, such as definitions, amendments are only referenced if they modified

the text being cited. For example, if a reference is made to a definition that has not been

modified by an amendment, then the reference to the amendment is not included in the dated

reference.
---------------------- Page: 5 ----------------------
– 4 – IEC 60601-1-6:2010/AMD2:2020
© IEC 2020
FOREWORD

Replace, in the existing fourth paragraph beginning with " This edition of IEC 60601-1-6 was

revised…", the reference to "IEC 62366" with "IEC 62366-1".

Replace, in the second dash of the existing ninth paragraph beginning with "In this collateral

standard, the following print types…", the reference to "IEC 62366" with "IEC 62366-1".

Replace the existing second paragraph before the last (including the footnote), beginning with

"To assist the user of this collateral standard…" and modified by Amendment 1, with the

following new paragraph and footnote:

To assist the user to implement the USABILITY ENGINEERING PROCESS, the Technical Report

IEC TR 62366-2 [1] is available. IEC TR 62366-2 contains tutorial information to assist

MANUFACTURERS in complying with this standard. The Technical Report also goes beyond

safety-related aspects and offers more detailed descriptions of USABILITY ENGINEERING methods

that can be applied to the development of ME EQUIPMENT.
Figures in square brackets refer to the Bibliography.
INTRODUCTION

Replace, in the second sentence before the last of the existing first paragraph, the term

OPERATOR-EQUIPMENT INTERFACE" with "OPERATOR INTERFACE".

Replace the last sentence of the existing first paragraph with the following new sentence:

The design of the OPERATOR INTERFACE to achieve safe use (adequate USABILITY) requires a

very different skill set than that of the technical implementation of that interface.

Replace, in the second paragraph, the reference "Figure A.1 of IEC 62366:2007" with

"Figure A.4 of IEC 62366-1:2015".
Replace, in the existing paragraph before the last, the last sentence with:

It should be noted that clinical investigations conducted according to ISO 14155 [2] and

USABILITY TESTS for FORMATIVE EVALUATION or SUMMATIVE EVALUATION according to this standard

are two fundamentally different activities and should not be confused.
1.1 * Scope

Replace, in the existing first paragraph, the words "design, VERIFY and VALIDATE USABILITY" with

"develop and evaluate the USABILITY".
Replace the existing third paragraph with the following new paragraph and note:

If the USABILITY ENGINEERING PROCESS detailed in this collateral standard has been complied

with, then the USABILITY of ME EQUIPMENT as it relates to BASIC SAFETY and ESSENTIAL

PERFORMANCE is presumed to be acceptable, unless there is OBJECTIVE EVIDENCE to the contrary.

NOTE Such OBJECTIVE EVIDENCE can subsequently originate from POST-PRODUCTION surveillance.

1.3.1 IEC 60601-1

Replace, in the first two bullet points of the existing second paragraph, the parentheses, added

by Amendment 1, with the words ", including any amendments".
---------------------- Page: 6 ----------------------
IEC 60601-1-6:2010/AMD2:2020 – 5 –
© IEC 2020
2 Normative references
Replace the existing references to IEC 60601-1 and IEC 62366, both modified by
Amendment 1, with the following new references:

IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for basic safety

and essential performance
Amendment 1:2012
Amendment 2:2020

IEC 62366-1:2015, Medical devices – Part 1: Application of usability engineering to medical

devices
Amendment 1:2020
Delete the reference to IEC 60601-1-8.
Replace the existing reference to ISO 14971 by the following new reference:

ISO 14971:2019, Medical devices – Application of risk management to medical devices

3 Terms and definitions
Replace the existing first paragraph with:
For the purposes of this document, the terms and definitions given in

IEC 60601-1:2005+A1:2012+A2:2020, IEC 62366-1:2015+A1:2020, ISO 14971:2019 and the

following definitions apply.
3.1
* OPERATOR-EQUIPMENT INTERFACE

Replace the existing term and definition with the following new term and definition:

3.1
* OPERATOR INTERFACE
means by which the OPERATOR and the ME EQUIPMENT interact

Note 1 to entry: The ACCOMPANYING DOCUMENTS are considered part of the ME EQUIPMENT and its OPERATOR

INTERFACE.

Note 2 to entry: OPERATOR INTERFACE includes all the elements of the ME EQUIPMENT with which the OPERATOR

interacts including the physical aspects of the ME EQUIPMENT as well as visual, auditory, tactile displays and is not

limited to a software interface.

Note 3 to entry: For the purposes of this standard, the MANUFACTURER may treat the combination of ME EQUIPMENT

and other equipment as a single OPERATOR INTERFACE.
Note 4 to entry: See IEC 62366-1:2015, 3.26.
3.2
OPERATOR PROFILE

Replace the existing term and definition with the following new term and definition:

3.2
OPERATOR PROFILE

summary of the mental, physical and demographic traits of the OPERATOR GROUP, as well as

characteristics, such as knowledge, skills and abilities, which can have a bearing on design

decisions
---------------------- Page: 7 ----------------------
– 6 – IEC 60601-1-6:2010/AMD2:2020
© IEC 2020

[SOURCE: IEC 62366-1:2015+A1:2020, definition 3.29, modified — Replaced "a USER GROUP"

with "the OPERATOR GROUP".]
Add the following new definition:
3.3
OPERATOR GROUP

OPERATORS who are differentiated from other OPERATORS by factors that are likely to

subset of
influence their interactions with the ME EQUIPMENT

Note 1 to entry: Attributes of OPERATOR GROUPS can include age, culture, expertise.

[SOURCE: IEC 62366-1:2015+A1:2020, 3.25, modified – Replaced "USER" with "OPERATOR" and

"MEDICAL DEVICE" with "ME EQUIPMENT".]
4.1 * Conditions for application to ME EQUIPMENT

Replace, in the existing first paragraph, "NORMAL USE and USE ERROR" with "NORMAL USE, i.e.

CORRECT USE and USE ERROR,".
4.2 * USABILITY ENGINEERING PROCESS for ME EQUIPMENT

Replace the existing text of 4.2, modified by Amendment 1, including footnote 3), with:

A USABILITY ENGINEERING PROCESS complying with IEC 62366-1:2015+A1:2020 shall be
performed except:

‒ the planning for and execution of production and POST-PRODUCTION monitoring in the context

of applying the USABILITY ENGINEERING PROCESS within the framework of ISO 14971, and

‒ maintenance of the USABILITY ENGINEERING PROCESS.

In applying IEC 62366-1:2015+A1:2020, the terms in this collateral standard and those in

IEC 60601-1:2005+A1:2012+A2:2020 shall be used as follows.
‒ The term "ACCOMPANYING DOCUMENTATION" shall assume the same meaning as
ACCOMPANYING DOCUMENTS.
‒ The term "MEDICAL DEVICE" shall assume the same meaning as ME EQUIPMENT.
‒ The term "USER" shall assume the same meaning as OPERATOR.
‒ The term "PATIENT" shall include animals.
‒ The term "SAFETY" shall assume the same meaning as BASIC SAFETY and ESSENTIAL
PERFORMANCE.
‒ The term "USER GROUP" shall assume the same meaning as OPERATOR GROUP.
‒ The term "USER INTERFACE" shall assume the same meaning as OPERATOR INTERFACE.
‒ The term "USER PROFILE" shall assume the same meaning as OPERATOR PROFILE.

Compliance is checked by inspection of the USABILITY ENGINEERING FILE. Evidence of compliance

with this clause and all requirements of this standard referring to inspection of the USABILITY

ENGINEERING FILE are satisfied if the MANUFACTURER has demonstrated compliance with

IEC 62366-1:2015+A1:2020.
5 * Replacement of requirements given in IEC 62366
Delete the existing asterisk before the title of Clause 5.

Replace the existing title of Clause 5 with "ME EQUIPMENT ACCOMPANYING DOCUMENTS".

---------------------- Page: 8 ----------------------
IEC 60601-1-6:2010/AMD2:2020 – 7 –
© IEC 2020

Delete the existing first paragraph, as well as the second paragraph (including footnote 3)

modified by Amendment 1.
Replace, in the existing third paragraph, the word "USABILITY" with "use".
Replace the existing last paragraph with the following new paragraphs:

The instructions for use shall contain a summary of the USE SPECIFICATION as specified in

IEC 62366-1:2015+A1:2020, 5.1.
Compliance is checked by inspection.
A.2 Rationale for particular clauses and subclauses
Subclause 1.1 – Scope

Replace, in the first sentence of the existing paragraph, the word "OPERATOR-EQUIPMENT

INTERFACE " with "OPERATOR INTERFACE".
Definition 3.1 – OPERATOR-EQUIPMENT INTERFACE

Replace, in the title and in the first sentence of the existing paragraph, the word "OPERATOR-

EQUIPMENT INTERFACE " with "OPERATOR INTERFACE" in two places.
Replace the existing dash list with the following new list:
– elements that require manual manipulation;
– cables and tubing connections;
– accessories;
– handles;
– force required to move the weight;
– work surface height;
– dimensions that affect reach requirements;
– markings and ACCOMPANYING DOCUMENTS;
– video displays;
– push buttons;
– touch screens;
– auditory, vibratory, tactile, and visual signals to inform OPERATORS;
– voice recognition;
– keyboard and mouse; and
– haptic controls.
Subclause 4.1 – Conditions for application to ME EQUIPMENT

Replace, in the existing first paragraph, the words "RISKS associated with USABILITY" by "use-

related RISKS" in two places.
Replace the existing last paragraph with the following new paragraph:

The criteria for judging RISK acceptability are described in the SUMMATIVE EVALUATION plan,

which specifies the criteria for determining that the OPERATOR INTERFACE can be used safely.

---------------------- Page: 9 ----------------------
– 8 – IEC 60601-1-6:2010/AMD2:2020
© IEC 2020
Subclause 4.2 – USABILITY ENGINEERING PROCESS for ME EQUIPMENT

Replace, in the existing fourth paragraph, added by Amendment 1, the reference "IEC 62366"

with "IEC 62366-1".
Replace, in the existing last paragraph, modified by Amendment 1, the reference

"IEC 60601-1:2005+A1:2012" with "IEC 60601-1:2005+A1:2012+A2:2020", as well as the

reference "IEC 62366" with "IEC 62366-1".
Clause 5 – Replacement of requirements given in IEC 62366
Delete the existing rationale for Clause 5, including its title.
Annex B – Mapping between the elements of IEC 60601-1-6:2006 and the related
elements in IEC 62366:2007
Delete the existing annex, modified by Amendment 1, including its title.
Annex C – References to items of USABILITY provided in IEC 62366:2007 and their
use in other standards
Delete the existing annex, including its title.
Bibliography
13)

Replace the existing references [1] to [27], including footnote , with the following new

references:

[1] IEC TR 62366-2, Medical devices – Part 2: Guidance on the application of usability

engineering to medical devices

[2] ISO 14155, Clinical investigation of medical devices for human subjects – Good clinical

practice
Index of defined terms used with this collateral standard

Delete the following terms and their references from the index, modified by Amendment 1:

ALARM LIMIT
ALARM OFF
EFFECTIVENESS
HAND-HELD
HAZARD
HAZARDOUS SITUATION
INTENDED USE
PRIMARY OPERATING FUNCTION
RESPONSIBLE ORGANIZATION
RISK ANALYSIS
RISK ASSESSMENT
RISK CONTROL
---------------------- Page: 10 ----------------------
IEC 60601-1-6:2010/AMD2:2020 – 9 –
© IEC 2020
RISK MANAGEMENT FILE
USABILITY SPECIFICATION
USE SCENARIO
VALIDATION
VERIFICATION
OPERATOR-EQUIPMENT INTERFACE" with " OPERATOR INTERFACE".
Replace the term "
Replace the following terms of the index, modified by Amendment 1:

ABNORMAL USE ........................................................................ IEC 62366-1:2015+A1:2020, 3.1

EFFICIENCY ............................................................................................. IEC 62366-1:2015, 3.5

INFORMATION SIGNAL ............................................................ IEC 60601-1:2005+A2:2020, 3.150

MANUFACTURER ...................................................................... IEC 60601-1:2005+A2:2020, 3.55

MEDICAL DEVICE ....................................................................................... ISO 14971:2019, 3.10

OBJECTIVE EVIDENCE ............................................... IEC 60601-1:2005+A1:2012+A2:2020, 3.72

PROCESS ............................................................................... IEC 60601-1:2005+A2:2020, 3.89

RESIDUAL RISK ....................................................... IEC 60601-1:2005+A1:2012+A2:2020, 3.100

RISK ..................................................................... IEC 60601-1:2005+A1:2012+A2:2020, 3.102

RISK MANAGEMENT ................................................................ IEC 60601-1:2005+A2:2020, 3.107

USABILITY ............................................................................. IEC 60601-1:2005+A2:2020, 3.136

USABILITY ENGINEERING ........................................................ IEC 60601-1:2005+A2:2020, 3.137

USABILITY ENGINEERING FILE ................................... IEC 60601-1:2005+A1:2012+A2:2020, 3.147

USE ERROR .......................................................................................... IEC 62366-1:2015, 3.21

USER .................................................................................................... IEC 62366-1:2015, 3.24

USER INTERFACE .................................................................................... IEC 62366-1:2015, 3.26

Add the following new terms:

ACCOMPANYING DOCUMENTATION ............................................... IEC 62366-1:2015+A1:2020, 3.2

CORRECT USE .......................................................................................... IEC 62366-1:2015, 3.3

FORMATIVE EVALUATION ........................................................................... IEC 62366-1:2015, 3.7

LIFE CYCLE .................................................................................................ISO 14971:2019, 3.8

OPERATOR GROUP.................................................................................................................. 3.3

POST-PRODUCTION .................................................................................... ISO 14971:2019, 3.12

SAFETY .................................................................................................... ISO 14971:2019, 3.26

SUMMATIVE EVALUATION ......................................................................... IEC 62366-1:2015, 3.13

USABILITY TEST ...................................................................................... IEC 62366-1:2015, 3.19

USE SPECIFICATION ................................................................. IEC 62366-1:2015+A1:2020, 3.23

USER GROUP .......................................................................... IEC 62366-1:2015+A1:2020, 3.25

USER PROFILE ........................................................................ IEC 62366-1:2015+A1:2020, 3.29

___________
---------------------- Page: 11 ----------------------
– 10 – IEC 60601-1-6:2010/AMD2:2020
© IEC 2020
AVANT-PROPOS
Le présent amendement a été établi par le sous-comité 62A: Aspects généraux des

équipements électriques utilisés en pratique médicale, du comité d’études 62 de l’IEC:

Équipements électriques dans la pratique médicale.
Le texte de cet amendement est issu des documents suivants:
FDIS Rapport de vote
62A/1391/FDIS 62A/1406/RVD

Le rapport de vote indiqué dans le tableau ci-dessus donne toute information sur le vote ayant

abouti à l'approbation de cet amendement.

Le comité a décidé que le contenu de cet amendement et de la publication de base ne sera pas

modifié avant la date de stabilité indiquée sur le site web de l'IEC sous "http://webstore.iec.ch"

dans les données relatives à la publication recherchée. À cette date, la publication sera

• reconduite,
• supprimée,
• remplacée par une édition révisée, ou
• amendée.

NOTE L’attention des utilisateurs du présent document est attirée sur le fait que les fabricants d’appareils et les

organismes d’essai peuvent avoir besoin d’une période transitoire après la publication d’une nouvelle publication

IEC ou ISO, ou d’une publication amendée ou révisée, pour fabriquer des produits conformes aux nouvelles

exigences et pour adapter leurs équipements aux nouveaux essais ou aux essais révisés. Le comité recommande

que le contenu de cette publication soit adopté pour application nationale obligatoire au plus tôt 3 ans après la date

de publication.
_____________
---------------------- Page: 12 ----------------------
IEC 60601-1-6:2010/AMD2:2020 – 11 –
© IEC 2020
INTRODUCTION A L’AMENDEMENT 2

La troisième édition de l’IEC 60601-1-6 a été publiée en 2010 et modifiée en 2013. Depuis la

publication de l’IEC 60601-1-6:2010+A1:2013, le secrétariat du sous-comité (SC) 62A de l’IEC

recueille les questions provenant de différentes sources, y compris les observations des

Comités nationaux. Lors de la réunion de l’IEC/SC 62A en novembre 2015 à Kobe, Japon, le

sous-comité a mis en place un processus d’identification des questions prioritaires qu’il y a lieu

de prendre en considération dans un amendement et pour lesquelles il convient que la réponse

n’attende pas la mise à disposition de la quatrième édition de l’IEC 60601-1-6 dont la date cible

de publication est actuellement prévue peu après 2024.

Les questions choisies pour être incluses dans la "liste restreinte" finale à traiter dans

l’Amendement 2 sont celles qui ont été approuvées par une majorité des 2/3 des Comités

nationaux présents votants lors de la réunion du SC 62A à Francfort. Lors de la réunion qui

s’est tenue le 10 octobre 2016, neuf points ont été soumis aux Comités nationaux présents.

Les neuf points ont recueilli la majorité exigée des 2/3 des Comités nationaux présents votants

et ont été inclus dans la "liste restreinte" en vue de leur prise en compte dans l’élaboration de

l’Amendement 2. Les questions en suspens ont toutes été incluses dans une "liste plus large"

afin d’être prises en compte dans la quatrième édition de l’IEC 60601-1-6.

La "liste restreinte" des questions a été documentée dans la spécification de conception pour

l’Amendement 2. Dans la mesure où ces questions sont étroitement liées à l’application de

l’IEC 62366-1 aux APPAREILS et aux SYSTEMES ELECTROMEDICAUX, la tâche a été affectée au

groupe de travail commun (JWG) 4 IEC/SC 62A-ISO/TC 210. Le JWG 4 a été chargé d’examiner

chaque question décrite dans l’Article 6 de la spécification de conception et d’élaborer une

solution appropriée pour le problème identifié. Cette solution finale incluse dans le présent

amendement peut englober toute solution technique proposée par l’auteur de la question ou

peut mettre en œuvre une solution différente élaborée par le groupe d’experts. Le groupe

d’experts peut également avoir recommandé de ne pas modifier le document lorsqu'il a estimé

que l’énoncé du problème ne le justifiait pas.

Le présent amendement met à jour la référence à l’IEC 62366:2007, désormais obsolète, et

renvoie à la version actuelle du processus d'ingénierie de l’aptitude à l’utilisation, à savoir

IEC 62366-1:2015+A1:2020.
Étant donné que
...

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