IEC 60601-2-35:2020/AMD1:2023
(Amendment)Amendment 1 - Medical electrical equipment - Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads or mattresses and intended for heating in medical use
Amendment 1 - Medical electrical equipment - Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads or mattresses and intended for heating in medical use
Amendement 1 - Appareils électromédicaux - Partie 2-35 : Exigences particulières pour la sécurité de base et les performances essentielles des dispositifs de réchauffage utilisant des couvertures, des coussins ou des matelas et destinés au réchauffage des patients en usage médical
General Information
Relations
Buy Standard
Standards Content (Sample)
IEC 60601-2-35 ®
Edition 2.0 2023-12
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
AMENDMENT 1
AMENDEMENT 1
Medical electrical equipment –
Part 2-35: Particular requirements for the basic safety and essential performance
of heating devices using blankets, pads or mattresses and intended for heating
in medical use
Appareils électromédicaux –
Partie 2-35 : Exigences particulières pour la sécurité de base et les
performances essentielles des dispositifs de réchauffage utilisant des
couvertures, des coussins ou des matelas et destinés au réchauffage des
patients en usage médical
IEC 60601-2-35:2020-09/AMD1:2023-12(en-fr)
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 Secretariat 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 IEC Products & Services Portal - products.iec.ch
The advanced search enables to find IEC publications by a Discover our powerful search engine and read freely all the
variety of criteria (reference number, text, technical publications previews. With a subscription you will always have
committee, …). It also gives information on projects, replaced access to up to date content tailored to your needs.
and withdrawn publications.
Electropedia - www.electropedia.org
IEC Just Published - webstore.iec.ch/justpublished
The world's leading online dictionary on electrotechnology,
Stay up to date on all new IEC publications. Just Published
containing more than 22 300 terminological entries in English
details all new publications released. Available online and once
and French, with equivalent terms in 19 additional languages.
a month by email.
Also known as the International Electrotechnical Vocabulary
(IEV) online.
IEC Customer Service Centre - webstore.iec.ch/csc
If you wish to give us your feedback on this publication or 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 - IEC Products & Services Portal - products.iec.ch
webstore.iec.ch/advsearchform Découvrez notre puissant moteur de recherche et consultez
La recherche avancée permet de trouver des publications IEC gratuitement tous les aperçus des publications. Avec un
en utilisant différents critères (numéro de référence, texte, abonnement, vous aurez toujours accès à un contenu à jour
comité d’études, …). Elle donne aussi des informations sur les adapté à vos besoins.
projets et les publications remplacées ou retirées.
Electropedia - www.electropedia.org
IEC Just Published - webstore.iec.ch/justpublished
Le premier dictionnaire d'électrotechnologie en ligne au monde,
Restez informé sur les nouvelles publications IEC. Just
avec plus de 22 300 articles terminologiques en anglais et en
Published détaille les nouvelles publications parues.
français, ainsi que les termes équivalents dans 19 langues
Disponible en ligne et une fois par mois par email.
additionnelles. Egalement appelé Vocabulaire
Electrotechnique International (IEV) en ligne.
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.
IEC 60601-2-35 ®
Edition 2.0 2023-12
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
AMENDMENT 1
AMENDEMENT 1
Medical electrical equipment –
Part 2-35: Particular requirements for the basic safety and essential performance
of heating devices using blankets, pads or mattresses and intended for heating
in medical use
Appareils électromédicaux –
Partie 2-35 : Exigences particulières pour la sécurité de base et les
performances essentielles des dispositifs de réchauffage utilisant des
couvertures, des coussins ou des matelas et destinés au réchauffage des
patients en usage médical
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 11.040.01, 11.140 ISBN 978-2-8322-8001-0
– 2 – IEC 60601-2-35:2020/AMD1:2023
© IEC 2023
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL ELECTRICAL EQUIPMENT –
Part 2-35: Particular requirements for the basic safety and essential
performance of heating devices using blankets, pads or mattresses
and intended for heating in medical use
AMENDMENT 1
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) IEC draws attention to the possibility that the implementation of this document may involve the use of (a)
patent(s). IEC takes no position concerning the evidence, validity or applicability of any claimed patent rights in
respect thereof. As of the date of publication of this document, IEC had not received notice of (a) patent(s), which
may be required to implement this document. However, implementers are cautioned that this may not represent
the latest information, which may be obtained from the patent database available at https://patents.iec.ch. IEC
shall not be held responsible for identifying any or all such patent rights.
Amendment 1 to IEC 60601-2-35:2020 has been prepared by subcommittee 62D: Particular
medical equipment, software, and systems, of IEC technical committee 62: Medical equipment,
software, and systems.
© IEC 2023
The text of this Amendment is based on the following documents:
Draft Report on voting
62D/2088/FDIS 62D/2108/RVD
Full information on the voting for its approval can be found in the report on voting indicated in
the above table.
The language used for the development of this Amendment is English.
This document was drafted in accordance with ISO/IEC Directives, Part 2, and developed in
accordance with ISO/IEC Directives, Part 1 and ISO/IEC Directives, IEC Supplement, available
at www.iec.ch/members_experts/refdocs. The main document types developed by IEC are
described in greater detail at www.iec.ch/publications/.
The committee has decided that the contents of this document will remain unchanged until the
stability date indicated on the IEC website under webstore.iec.ch in the data related to the
specific document. At this date, the document will be
• reconfirmed,
• withdrawn, or
• revised.
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.
___________
INTRODUCTION to Amendment 1
At the October 2019 meeting of IEC SC 62D in Shanghai, China, the subcommittee discussed
the need for administrative/technical changes to most 62D standards after completion of the
amendment projects within the IEC 60601-1 series. Those projects were all completed and the
amendments published in 2020.
The full list of IEC SC 62D documents that will be amended or revised can be found within the
IEC document 62D/1792/DC. The results and comments on the DC can be found within
62D/1808/INF. The review report for this amendment is 62D/1815/RR.
___________
– 4 – IEC 60601-2-35:2020/AMD1:2023
© IEC 2023
201.1 Scope, object and related standards
Replace the existing footnote 1 with the following new footnote:
The general standard is IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and
IEC 60601‑1:2005/AMD2:2020, Medical electrical equipment – Part 1: General requirements
for basic safety and essential performance.
201.1.3 Collateral standards
Replace the existing second paragraph with the following new paragraph:
IEC 60601‑1‑2:2014 and IEC 60601‑1‑2:2014/AMD1:2020, IEC 60601‑1‑8:2006,
IEC 60601‑1‑8:2006/AMD1:2012, and IEC 60601‑1‑8:2006/AMD2:2020, IEC 60601‑1‑10:2007,
IEC 60601‑1‑10:2007/AMD1:2013 and IEC 60601‑1‑10:2007/AMD2:2020 apply as modified in
Articles 202, 208 and 210 respectively. IEC 60601-1-3 does not apply. All other published
collateral standards in the IEC 60601-1 series apply as published.
201.1.4 Particular standards
Replace, in the existing third paragraph, "IEC 60601‑1:2005 and
IEC 60601‑1:2005/AMD1:2012" with "IEC 60601‑1:2005, IEC 60601‑1:2005/AMD1:2012 and
IEC 60601‑1:2005/AMD2:2020".
201.2 Normative references
Replace the existing references to IEC 60601-1, IEC 60601-1-2 and IEC 60601-1-10 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 60601-1-10:2007, Medical electrical equipment – Part 1-10: General requirements for basic
safety and essential performance – Collateral Standard: Requirements for the development of
physiologic closed-loop controllers
IEC 60601-1-10:2007/AMD1:2013
IEC 60601-1-10:2007/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
201.3 Terms and definitions
Replace, in the existing
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.