Amendment 1 - 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

Amendement 1 - Appareils électromédicaux - Partie 1-12: Exigences générales pour la sécurité de base et les performances essentielles - Norme collatérale: Exigences pour les appareils électromédicaux et les systèmes électromédicaux destinés à être utilisés dans l'environnement des services médicaux d'urgence

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 60601-1-12:2014/AMD1:2020 - Amendment 1 - 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
English and French language
9 pages
sale 15% off
Preview
sale 15% off
Preview

Standards Content (sample)

IEC 60601-1-12
Edition 1.0 2020-07
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
AMENDMENT 1
AMENDEMENT 1
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
Appareils électromédicaux –
Partie 1-12: Exigences générales pour la sécurité de base et les performances
essentielles – Norme collatérale: Exigences pour les appareils électromédicaux
et les systèmes électromédicaux destinés à être utilisés dans l'environnement
des services médicaux d'urgence
IEC 60601-1-12:2014-06/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 67 000 electrotechnical terminology entries in English and

once a month by email. French extracted from the Terms and definitions clause of

IEC publications issued between 2002 and 2015. Some

IEC Customer Service Centre - webstore.iec.ch/csc entries have been collected from earlier publications of IEC

If you wish to give us your feedback on this publication or TC 37, 77, 86 and CISPR.

need 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 - Electropedia - www.electropedia.org

webstore.iec.ch/advsearchform Le premier dictionnaire d'électrotechnologie en ligne au

La recherche avancée permet de trouver des publications IEC monde, avec plus de 22 000 articles terminologiques en

en utilisant différents critères (numéro de référence, texte, anglais et en français, ainsi que les termes équivalents dans

comité d’études,…). Elle donne aussi des informations sur les 16 langues additionnelles. Egalement appelé Vocabulaire

projets et les publications remplacées ou retirées. Electrotechnique International (IEV) en ligne.

IEC Just Published - webstore.iec.ch/justpublished Glossaire IEC - std.iec.ch/glossary

Restez informé sur les nouvelles publications IEC. Just 67 000 entrées terminologiques électrotechniques, en anglais

Published détaille les nouvelles publications parues. et en français, extraites des articles Termes et définitions des

Disponible en ligne et une fois par mois par email. publications IEC parues entre 2002 et 2015. Plus certaines

entrées antérieures extraites des publications des CE 37, 77,
Service Clients - webstore.iec.ch/csc 86 et CISPR de l'IEC.
Si vous désirez nous donner des commentaires sur cette
publication ou si vous avez des questions contactez-nous:
sales@iec.ch.
---------------------- Page: 2 ----------------------
IEC 60601-1-12
Edition 1.0 2020-07
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
A MENDMENT 1
AM ENDEMENT 1
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
Appareils électromédicaux –
Partie 1-12: Exigences générales pour la sécurité de base et les performances
essentielles – Norme collatérale: Exigences pour les appareils électromédicaux
et les systèmes électromédicaux destinés à être utilisés dans l'environnement
des services médicaux d'urgence
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 11.040.01 ISBN 978-2-8322-8625-8

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 60601-1-12:2014/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/1396/FDIS 62A/1411/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 16 P

members out of 16 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 60601-1-12:2014/AMD1:2020 – 3 –
© IEC 2020
INTRODUCTION TO AMENDMENT 1

The first edition of IEC 60601-1-12 was published in 2014. Since the publication of

IEC 60601-1-12:2014, 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

second edition of IEC 60601-1-12, which is presently targeted for publication sometime after

2024.

As directed in item 1 of Kobe Resolution 1, the IEC/SC 62A Chairman Advisory Group (CAG)

considered the 27 issues collected by the SC/62A Secretariat for IEC 60601-1-12:2014 and

determined that none met the selection criteria stated in Kobe Resolution 1.
However, an amendment is needed to update the references to IEC 60601-1:2005,
IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020. In London in 2018,

SC 62A approved the development of an administrative amendment to IEC 60601-1-12:2014.

Because this is an amendment to IEC 60601-1-12:2014, the style in force at the time of

publication of IEC 60601-1-12 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 60601-1-12:2014/AMD1:2020
© IEC 2020
1.3.1 IEC 60601-1

Delete, in the existing first paragraph, the words "hereafter referred to as the general

standard".

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 60601-1-11 and ISO 7010 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/AMD1:2020

IEC 60601-1-11:2015, 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

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

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

signs
3 Terms and definitions
Replace the existing first paragraph with:
For the purposes of this doc
...

Questions, Comments and Discussion

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