Amendment 1 - Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment

Amendement 1 - Appareils électromédicaux - Partie 1-11 : Exigences générales pour la sécurité de base et les performances essentielles - Norme collatérale : Exigences pour les appareils électromédicaux et les systèmes électromédicaux utilisés dans l'environnement des soins à domicile

General Information

Status
Published
Publication Date
21-Jul-2020
Current Stage
PPUB - Publication issued
Completion Date
22-Jul-2020
Ref Project

Buy Standard

Standard
IEC 60601-1-11:2015/AMD1:2020 - Amendment 1 - Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
English and French language
16 pages
sale 15% off
Preview
sale 15% off
Preview

Standards Content (sample)

IEC 60601-1-11
Edition 2.0 2020-07
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
AMENDMENT 1
AMENDEMENT 1
Medical electrical equipment –
Part 1-11: General requirements for basic safety and essential performance –
Collateral Standard: Requirements for medical electrical equipment and medical
electrical systems used in the home healthcare environment
Appareils électromédicaux –
Partie 1-11: Exigences générales pour la sécurité de base et les performances
essentielles – Norme Collatérale: Exigences pour les appareils électromédicaux
et les systèmes électromédicaux utilisés dans l’environnement des soins à
domicile
IEC 60601-1-11:2015-01/AMD1:2020-07(en-fr)
---------------------- Page: 1 ----------------------
THIS PUBLICATION IS COPYRIGHT PROTECTED
Copyright © 2020 IEC, Geneva, Switzerland

All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form

or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from

either IEC or IEC's member National Committee in the country of the requester. If you have any questions about IEC

copyright or have an enquiry about obtaining additional rights to this publication, please contact the address below or

your local IEC member National Committee for further information.

Droits de reproduction réservés. Sauf indication contraire, aucune partie de cette publication ne peut être reproduite ni

utilisée sous quelque forme que ce soit et par aucun procédé, électronique ou mécanique, y compris la photocopie et

les microfilms, sans l'accord écrit de l'IEC ou du Comité national de l'IEC du pays du demandeur. Si vous avez des

questions sur le copyright de l'IEC ou si vous désirez obtenir des droits supplémentaires sur cette publication, utilisez

les coordonnées ci-après ou contactez le Comité national de l'IEC de votre pays de résidence.

IEC Central Office Tel.: +41 22 919 02 11
3, rue de Varembé info@iec.ch
CH-1211 Geneva 20 www.iec.ch
Switzerland
About the IEC

The International Electrotechnical Commission (IEC) is the leading global organization that prepares and publishes

International Standards for all electrical, electronic and related technologies.
About IEC publications

The technical content of IEC publications is kept under constant review by the IEC. Please make sure that you have the

latest edition, a corrigendum or an amendment might have been published.

IEC publications search - webstore.iec.ch/advsearchform Electropedia - www.electropedia.org

The advanced search enables to find IEC publications by a The world's leading online dictionary on electrotechnology,

variety of criteria (reference number, text, technical containing more than 22 000 terminological entries in English

committee,…). It also gives information on projects, replaced and French, with equivalent terms in 16 additional languages.

and withdrawn publications. Also known as the International Electrotechnical Vocabulary

(IEV) online.
IEC Just Published - webstore.iec.ch/justpublished

Stay up to date on all new IEC publications. Just Published IEC Glossary - std.iec.ch/glossary

details all new publications released. Available online and once 67 000 electrotechnical terminology entries in English and

a month by email. French extracted from the Terms and definitions clause of IEC
publications issued between 2002 and 2015. Some entries

IEC Customer Service Centre - webstore.iec.ch/csc have been collected from earlier publications of IEC TC 37, 77,

If you wish to give us your feedback on this publication or need 86 and CISPR.
further assistance, please contact the Customer Service
Centre: sales@iec.ch.
A propos de l'IEC

La Commission Electrotechnique Internationale (IEC) est la première organisation mondiale qui élabore et publie des

Normes internationales pour tout ce qui a trait à l'électricité, à l'électronique et aux technologies apparentées.

A propos des publications IEC

Le contenu technique des publications IEC est constamment revu. Veuillez vous assurer que vous possédez l’édition la

plus récente, un corrigendum ou amendement peut avoir été publié.

Recherche de publications IEC - Le premier dictionnaire d'électrotechnologie en ligne au monde,

webstore.iec.ch/advsearchform avec plus de 22 000 articles terminologiques en anglais et en

La recherche avancée permet de trouver des publications IEC français, ainsi que les termes équivalents dans 16 langues

en utilisant différents critères (numéro de référence, texte, additionnelles. Egalement appelé Vocabulaire

comité d’études,…). Elle donne aussi des informations sur les Electrotechnique International (IEV) en ligne.

projets et les publications remplacées ou retirées.
Glossaire IEC - std.iec.ch/glossary

IEC Just Published - webstore.iec.ch/justpublished 67 000 entrées terminologiques électrotechniques, en anglais

Restez informé sur les nouvelles publications IEC. Just et en français, extraites des articles Termes et définitions des

Published détaille les nouvelles publications parues. publications IEC parues entre 2002 et 2015. Plus certaines

Disponible en ligne et une fois par mois par email. entrées antérieures extraites des publications des CE 37, 77,

86 et CISPR de l'IEC.
Service Clients - webstore.iec.ch/csc
Si vous désirez nous donner des commentaires sur cette
publication ou si vous avez des questions contactez-nous:
sales@iec.ch.
Electropedia - www.electropedia.org
---------------------- Page: 2 ----------------------
IEC 60601-1-11
Edition 2.0 2020-07
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
A MENDMENT 1
AM ENDEMENT 1
Medical electrical equipment –
Part 1-11: General requirements for basic safety and essential performance –
Collateral Standard: Requirements for medical electrical equipment and medical
electrical systems used in the home healthcare environment
Appareils électromédicaux –
Partie 1-11: Exigences générales pour la sécurité de base et les performances
essentielles – Norme Collatérale: Exigences pour les appareils électromédicaux
et les systèmes électromédicaux utilisés dans l’environnement des soins à
domicile
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 11.020.10; 11.040.01 ISBN 978-2-8322-8623-4

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: 3 ----------------------
– 2 – IEC 60601-1-11:2015/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 subcommittee 3: Respiratory devices and related equipment used for

patient care of ISO technical committee 121: Anaesthetic and respiratory equipment.

It is published as a double logo amendment.
The text of this amendment is based on the following documents of IEC:
FDIS Report on voting
62A/1395/FDIS 62A/1410/RVD

Full information on the voting for the approval of this amendment can be found in the report on

voting indicated in the above table. In ISO, the amendment has been approved by 15 P

members out of 15 having cast a vote.

The committee has decided that the contents of this amendment and the base publication will

remain unchanged until the stability date indicated on the IEC web site under

"http://webstore.iec.ch" in the data related to the specific publication. At this date, the

publication will be
• reconfirmed,
• withdrawn,
• replaced by a revised edition, or
• amended.

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 60601-1-11:2015/AMD1:2020 – 3 –
© IEC 2020
INTRODUCTION TO AMENDMENT 1

The second edition of IEC 60601-1-11 was published in 2015. Since the publication of

IEC 60601-1-11:2015, 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 third

edition of IEC 60601-1-11, which is presently targeted for publication sometime after 2024.

Those issues selected for inclusion on the final "short list" to be addressed in Amendment 1

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, four items were

presented to the National Committees present. All four 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 1. All remaining issues have been placed on a "long list"

for consideration in the third edition of IEC 60601-1-11.

The "short list" of issues was documented in the design specification for Amendment 1. As

IEC 60601-1-11 was jointly developed with ISO/TC 121/SC 3, the work was assigned to

IEC/SC 62A-ISO/TC 121/SC 3 Joint Working Group (JWG) 6. JWG 6 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 standard was justified by the problem statement.

Because this is an amendment to IEC 60601-1-11:2015, the style in force at the time of

publication of IEC 60601-1-11 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.

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 60601-1-11:2015/AMD1:2020
© IEC 2020
1.3.1 IEC 60601-1

Add, in the first two dashes of the existing second paragraph, the words ", including any

amendments".
2 Normative references

Replace the existing references to IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-

8, IEC 60601-1-12, IEC 62366-1, ISO 7010 and ISO 15223-1 with the following new references:

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

and essential performance
IEC 60601-1:2005/AMD1:2012
IEC 60601-1:2005/AMD2:2020

IEC 60601-1-2:2014, Medical electrical equipment – Part 1-2: General requirements for basic

safety and essential performance – Collateral Standard: Electromagnetic disturbances –

Requirements and tests
IEC 60601-1-2:2014/AMD1:2020

IEC 60601-1-6:2010, Medical electrical equipment – Part 1-6: General requirements for basic

safety and essential performance – Collateral standard: Usability
IEC 60601-1-6:2010/AMD1:2013
IEC 60601-1-6:2010/AMD2:2020

IEC 60601-1-8:2006, Medical electrical equipment – Part 1-8: General requirements for basic

safety and essential performance – Collateral Standard: General requirements, tests and

guidance for alarm systems in medical electrical equipment and medical electrical systems

IEC 60601-1-8:2006/AMD1:2012
IEC 60601-1-8:2006/AMD2:2020

IEC 60601-1-12:2014, Medical electrical equipment – Part 1-12: General requirements for basic

safety and essential performance – Collateral Standard: Requirements for medical electrical

equipment and medical electrical systems intended for use in the emergency medical services

environment
IEC 60601-1-12:2014/AMD1:2020

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

devices
IEC 62366-1:2015/AMD1:2020

ISO 7010:2019, Graphical symbols – Safety colours and safety signs – Registered safety signs

ISO 15223-1:2016, Medical devices – Symbols to be used with medical device labels, labelling

and information to be supplied – Part 1: General requirements
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 and

IEC 60601-1:2005:AMD1:2012 + IEC 60601-1:2005/AMD2:2020, IEC 60601-1-2:2014 and

IEC 60601-1-2:2014/AMD1:2020, IEC 60601-1-6:2010 and IEC 60601-1-6:2010/AMD1:2013 +

IEC 60601-1-6:2010/AMD2:2020, IEC 60601-1-8:2006 and IEC 60601-1-8:2006/AMD1:2012 +

IEC 60601-1-8:2006/AMD2:2020, IEC 60601-1-12:2014 and

IEC 60601‑1‑12:2014/AMD1:2020, IEC 62366-1:2015 and IEC 62366-1:2015/AMD1:2020, and

the following definitions apply.
---------------------- Page: 6 ----------------------
IEC 60601-1-11:2015/AMD1:2020 – 5 –
© IEC 2020
4.2.2 * Environmental conditions of transport and storage between uses
Replace, in the existing fourth paragraph, the reference "ISO 15223-1:2012" with
"ISO 15223-1:2016" in three places.
4.2.3.1 Continuous operating conditions
Replace, in the existing fourth paragraph, the reference "ISO 15223-1:2012" with
"ISO 15223-1:2016" in three places.
7.2 * Additional requirements for marking of IP classification
Replace the existing first paragraph with:

In addition to the requirements of 7.2.9 of the general standard, the ME EQUIPMENT or its parts

and, when appropriate, a carrying case shall be marked with the appropriate IP classification

as tested in 8.3.1.

If some or all of the protection against the ingress of water or particulate matter is provided by

a carrying case, then:

ENCLOSURE of the ME EQUIPMENT shall be marked with its degree of protection and SAFETY

a) the

SIGN ISO 7010-W001 (see IEC 60601-1:2005, Table D.2, SAFETY SIGN 2), as well as with

– 'keep dry', or
– the symbol ISO 15223-1:2016, 5.3.4 (ISO 7000-0626 (2014-06)) (see Table C.1,
symbol 1); and
b) the carrying case shall be marked with its degree of protection.

If the ENCLOSURE of the ME EQUIPMENT is classified IPXX, IP00, IPX0 or IP0X, then it need not

be marked as such. However, the other marking requirements in a) still apply.
Add, at the end of the existing example, the following new sentence:

The ENCLOSURE, when installed in the carrying case, would comply with the IP22 test requirement in 8.3.1.

7.4.1 Additional requirements for warning and safety notices
In the existing first paragraph, replace "safety sign" with "SAFETY SIGN".
8.3.1 * Ingress of water or particulate matter into ME EQUIPMENT
Add, after the existing first paragraph, the following new paragraph:

If some or all of the protection against the ingress of water or particulate matter is provided by

a carrying case, then the ME EQUIPMENT shall be tested while inside the carrying case.

8.5 Additional requirements for an INTERNAL ELECTRICAL POWER SOURCE
Add, after 8.5.2, the following new subclause:
8.5.3 * Additional requirements for separation of parts

For ME EQUIPMENT or ME SYSTEM with an INTERNAL ELECTRICAL POWER SOURCE, if simultaneous

connection of the ME EQUIPMENT to the PATIENT and the SUPPLY MAINS is possible, then APPLIED

PARTS and parts that are likely to come into contact with the PATIENT shall have two MOPP from

the SUPPLY MAINS.
---------------------- Page: 7 ----------------------
– 6 – IEC 60601-1-11:2015/AMD1:2020
© IEC 2020

However, parts which the PATIENT intentionally handles as the intended OPERATOR according to

7.9.2.1 of IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012 + IEC 60601-

1:2005/AMD2:2020 (e.g. touch keys, ENCLOSURE) while the ME EQUIPMENT is not being used for

its intended medical function may be insulated with two MOOP from SUPPLY MAINS.
A.1 General guidance

Replace, in the existing last paragraph, the reference "IEC 60601-1:2005/AMD1:2012" with

"IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012 + IEC 60601-1:2005/AMD2:2020".
A.2 Rationale for particular clauses and subclauses
Subclause 7.1 – USABILITY of the ACCOMPANYING DOCUMENTS

Replace, in the existing first paragraph, the reference "IEC 60601-1-6:2010 and IEC 60601-1-

6/AMD1:2013" with "IEC 60601-1-6:2010 and IEC 60601-1-6/AMD1:2013 + IEC 60601-1-
6:2010/AMD2:2020".
Replace the existing next-to-last paragraph with:

Most often, some combination of these methods is used to develop a USE SPECIFICATION for the

most effective ACCOMPANYING DOCUMENTS possible. The MANUFACTURER VERIFIES that the final

ACCOMPANYING DOCUMENTS fulfil the USE SPECIFICATION typically by testing with representative

LAY OPERATORS.
Subclause 8.3.1 – Ingress of water or particulate matter into ME EQUIPMENT
Add, after the existing last paragraph, the following new paragraphs:

Care should be taken to ensure that liquid does not accumulate or that it drains away such that

it does not:
– interfere with BASIC SAFETY or ESSENTIAL PERFORMANCE;

– deposit on insulation parts where it could lead to tracking along the creepage distances; or

– reach live parts, including INTERNAL ELECTRICAL POWER SOURCES, or windings not designed

to operate when wet.

There are particular standards that exempt certain types of ME EQUIPMENT from these

requirements.
Add, after the existing rationale for 8.5.1, the following new text:
Subclause 8.5.3 – Additional requirements for separation of parts

ME EQUIPMENT that is BODY-WORN and used in the HOME HEALTHCARE ENVIRONMENT clearly

requires two MOPP.
If ME EQUIPMENT is:

– INTERNALLY POWERED during its INTENDED USE (e.g. a BODY-WORN ME EQUIPMENT); and

– constructed such that it can only be connected to an external power source (e.g. a battery

charger) while disconnected from the PATIENT;
then, during charging:

– the PATIENT is only in contact with ACCESSIBLE PARTS but not with APPLIED PARTS.

---------------------- Page: 8 ----------------------
IEC 60601-1-11:2015/AMD1:2020 – 7 –
© IEC 2020

The PATIENTS, now in their role as LAY OPERATORS, can just as well handle a cell phone or a

notebook, as they can connect that specifically designed ME EQUIPMENT to the charger. So, the

separation of ACCESSIBLE PARTS (other than APPLIED PARTS) from external power sources needs

only MOOP instead of MOPP in this specific case.

A SUPPLY MAINS connected charger is permitted by the general standard to be IEC 60950-1 [8]

[27] compliant as long as simultaneous connection of the ME EQUIPMENT or
or IEC 62368-1

ME SYSTEM to the charger and to the PATIENT is not possible. In this case, only MOOP is required.

If simultaneous connection of the ME EQUIPMENT to the PATIENT and the ME EQUIPMENT to a

SUPPLY MAINS-connected charger is possible, then clearly two MOPP are required and the charger

might need to comply with the MOPP requirements of IEC 60601-1 to achieve two MOPP.

Table C.1 – General symbols

Replace, in the existing reference column, the reference "ISO 15223-1:2012" with "ISO 15223-

1:2016" in six places.
Replace, for symbol no. 1, the reference "2004-01" with "2014-06".
Bibliography
Add, at the end of the existing Bibliography, the following new reference:

[27] IEC 62368-1:2018, Audio/video, information and communication technology equipment

– Part 1: Safety requirements
Index of defined terms used in this collateral standard
Replace the following existing terms:

DISTRIBUTED ALARM SYSTEM ............................................ IEC 60601-1-8:2006/AMD2:2020, 3.17

HAZARD...........................................................IEC 60601-1:2005/AMD1:2012/AMD2:2020, 3.39

HAZARDOUS SITUATION ........................................................ IEC 60601-1:2005/AMD2:2020, 3.40

HIGH PRIORITY .................................................................. IEC 60601-1:2005/AMD2:2020, 3.149

INFORMATION SIGNAL ........................................................ IEC 60601-1:2005/AMD2:2020, 3.150

INTENDED USE .................................................................... IEC 60601-1:2005/AMD2:2020,

...

Questions, Comments and Discussion

Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.