IEC 80601-2-35:2009

Medical electrical equipment - Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads and mattresses and intended for heating in medical use

IEC 80601-2-35:2009 establishes particular basic safety and essential performance requirements, which minimize hazards to patients, and operators for heating devices using blankets, pads or mattresses and intended for heating in medical use and specifies tests for demonstrating compliance with these requirements. This second edition cancels and replaces the first edition published in 1996. This edition constitutes a technical revision. This new edition provides consistency with the third edition of IEC 60601-1, as well as with the four other particular standards related to paediatric equipment for which the committee is responsible. The contents of the corrigenda of March 2012 and of February 2015 have been included in this copy.

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 chauffants et destinés au réchauffage des patients en usage médical

La CEI 80601-2-35:2009 établit des exigences particulières pour la sécurité de base et les performances essentielles, afin de réduire les dangers pour les patients et les opérateurs, pour les dispositifs de réchauffage utilisant des couvertures, des coussins ou des matelas chauffants et destinés au réchauffage des patients en usage médical, et spécifie des essais pour démontrer la conformité à ces exigences. Cette deuxième édition annule et remplace la première édition publiée en 1996, dont elle constitue une révision technique. Cette nouvelle édition assure la cohérence avec la troisième édition de la CEI 60601-1, ainsi qu'avec les quatre autres normes particulières relatives aux appareils pédiatriques dont le comité est responsable. Le contenu des corrigendas de mars 2012 et de février 2015 a été pris en considération dans cet exemplaire.

General Information

• Status: Replaced
• Publication Date: 28-Apr-2016
• ICS: 01 - GENERALITIES. TERMINOLOGY. STANDARDIZATION. DOCUMENTATION
• ICS: 11.040.01 - Medical equipment in general
• ICS: 11.140 - Hospital equipment
• Technical Committee: SC 62D - Particular medical equipment, software, and systems
• Drafting Committee: MT 21 - TC 62/SC 62D/MT 21
• Current Stage: DELPUB - Deleted Publication
• Start Date: 28-Dec-2018
• Completion Date: 21-Sep-2020

Relations

• Replaces: IEC 60601-2-35:1996 - Medical electrical equipment - Particular requirements for the safety of blankets, pads and mattresses intended for heating in medical use
• Effective Date: 05-Sep-2023
• Replaced By: IEC 60601-2-35:2020 - Medical electrical equipment - Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads and mattresses and intended for heating in medical use
• Effective Date: 05-Sep-2023
• Amended By: IEC 80601-2-35:2009/AMD1:2016 - 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
• Effective Date: 05-Sep-2023
• Corrected By: IEC 80601-2-35:2009/COR2:2015 - Corrigendum 2 - 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
• Effective Date: 05-Sep-2023
• Corrected By: IEC 80601-2-35:2009/COR1:2012 - Corrigendum 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
• Effective Date: 05-Sep-2023

Standards Content (Sample)

IEC 80601-2-35
Edition 2.0 2009-10
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
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 chauffants et destinés au réchauffage des patients en
usage médical
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 la CEI ou du Comité national de la CEI du pays du demandeur.
Si vous avez des questions sur le copyright de la CEI ou si vous désirez obtenir des droits supplémentaires sur cette
publication, utilisez les coordonnées ci-après ou contactez le Comité national de la CEI de votre pays de résidence.

IEC Central Office
3, rue de Varembé
CH-1211 Geneva 20
Switzerland
Email: [e-mail]
Web: www.iec.ch
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 corrigenda or an amendment might have been published.
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Vocabulary online.
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normes internationales pour tout ce qui a trait à l'électricité, à l'électronique et aux technologies apparentées.

A propos des publications CEI
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IEC 80601-2-35
Edition 2.0 2009-10
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
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 chauffants et destinés au réchauffage des patients en
usage médical
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
PRICE CODE
INTERNATIONALE
XB
CODE PRIX
ICS 11.040.01; 11.140 ISBN 978-2-88910-782-7

– 2 – 80601-2-35  IEC:2009
CONTENTS
FOREWORD . 4
INTRODUCTION . 7
201.1 Scope, object and related standards . 8
201.2 Normative references . 10
201.3 Terms and definitions. 10
201.4 General requirements . 13
201.5 General requirements for testing ME EQUIPMENT . 14
201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 14
201.7 ME EQUIPMENT identification, marking and documents . 14
201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 17
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 22
201.10 Protection against unwanted and excessive radiation HAZARDS . 24
201.11 Protection against excessive temperatures and other HAZARDS . 24
201.12 Accuracy of controls and instruments and protection against hazardous
outputs . 27
201.13 HAZARDOUS SITUATIONS and fault conditions . 32
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 37
201.15 Construction of ME EQUIPMENT . 37
201.16 ME SYSTEMS . 41
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 41
202 Electromagnetic compatibility – Requirements and tests . 42
208 General requirements, tests and guidance for ALARM SYSTEMS in MEDICAL
ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS. 42
210 * Requirements for the development of physiologic closed-loop controllers . 42
Annex D (informative) Symbols on marking . 43
Annex AA (informative) Particular guidance and rationale . 44
Annex BB (normative) Determination of the LAGGING MATERIAL . 55
Annex CC (normative) *Determination of heat transfer towards the PATIENT . 56
Annex DD (normative) *Determination of heat transfer away from the PATIENT . 58
Annex EE (normative) Conditions of adequate heat discharge . 59
Annex FF (normative) Test procedure for maximum CONTACT SURFACE TEMPERATURE
for FORCED AIR DEVICES . 60
Annex GG (normative) Test procedure for maximum CONTACT SURFACE TEMPERATURE
for FORCED AIR DEVICES under SINGLE FAULT CONDITION. 62
Annex HH (normative) Safety test procedure for average CONTACT SURFACE
TEMPERATURE for FORCED AIR DEVICES . 63
Bibliography . 65
Index of defined terms used in this particular standard. 66

Figure 201.101 – Positioning of temperature sensors on the contact surface of the
heated area of a HEATING DEVICE (see 201.12.4.101 and 201.12.4.105) . 11

80601-2-35  IEC:2009 – 3 –
Figure 201.102 – Example of the positioning of temperature sensors on the contact
surface of the heated areas of a HEATING DEVICE having more than one separately
heated area . 11
Figure 201.103 a) – Apparatus for the spark ignition test – Detail A: The apparatus
(see 201.8.8.4.101) . 19
Figure 201.103 b) – Apparatus for the spark ignition test – Detail B: Lower member of
mask . 20
Figure 201.103 c) – Apparatus for the spark ignition test – Detail C: Upper member of
mask . 20
Figure 201.103 – Apparatus for the spark ignition test . 20
Figure 201.104 – Ramp for the impact test on PADS . 23
Figure 201.105 – Partial covering conditions . 25
Figure 201.106 – Method of folding BLANKETS . 34
Figure 201.107 – Examples of folds . 36
Figure 201.108 – Positions of a BLANKET for the RUCK-RESISTANCE test. 41
Figure HH.1 – Sensor locations – Average CONTACT SURFACE TEMPERATURE . 64

Table 201.101 – *Additional ESSENTIAL PERFORMANCE requirements . 13
Table 201.102 – Temperature limits in dependency to time . 38

– 4 – 80601-2-35  IEC:2009
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

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 mark
...

IEC 80601-2-35
Edition 1.0 2009-10
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
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 chauffants et destinés au réchauffage des patients en
usage médical
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 la CEI ou du Comité national de la CEI du pays du demandeur.

Si vous avez des questions sur le copyright de la CEI ou si vous désirez obtenir des droits supplémentaires sur cette

publication, utilisez les coordonnées ci-après ou contactez le Comité national de la CEI de votre pays de résidence.
IEC Central Office
3, rue de Varembé
CH-1211 Geneva 20
Switzerland
Email: [e-mail]
Web: www.iec.ch
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 corrigenda or an amendment might have been published.
ƒ Catalogue of IEC publications: www.iec.ch/searchpub
The IEC on-line Catalogue enables you to search by a variety of criteria (reference number, text, technical committee,…).
It also gives information on projects, withdrawn and replaced publications.
ƒ IEC Just Published: www.iec.ch/online_news/justpub
Stay up to date on all new IEC publications. Just Published details twice a month all new publications released. Available
on-line and also by email.
ƒ Electropedia: www.electropedia.org
The world's leading online dictionary of electronic and electrical terms containing more than 20 000 terms and definitions
in English and French, with equivalent terms in additional languages. Also known as the International Electrotechnical
Vocabulary online.
ƒ Customer Service Centre: www.iec.ch/webstore/custserv
If you wish to give us your feedback on this publication or need further assistance, please visit the Customer Service
Centre FAQ or contact us:
Email: [e-mail]
Tel.: [phone]
Fax: [phone]
A propos de la CEI
La Commission Electrotechnique Internationale (CEI) 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 CEI
Le contenu technique des publications de la CEI est constamment revu. Veuillez vous assurer que vous possédez
l’édition la plus récente, un corrigendum ou amendement peut avoir été publié.
ƒ Catalogue des publications de la CEI: www.iec.ch/searchpub/cur_fut-f.htm
Le Catalogue en-ligne de la CEI vous permet d’effectuer des recherches en utilisant différents critères (numéro de référence,
texte, comité d’études,…). Il donne aussi des informations sur les projets et les publications retirées ou remplacées.
ƒ Just Published CEI: www.iec.ch/online_news/justpub
Restez informé sur les nouvelles publications de la CEI. Just Published détaille deux fois par mois les nouvelles
publications parues. Disponible en-ligne et aussi par email.
ƒ Electropedia: www.electropedia.org
Le premier dictionnaire en ligne au monde de termes électroniques et électriques. Il contient plus de 20 000 termes et
définitions en anglais et en français, ainsi que les termes équivalents dans les langues additionnelles. Egalement appelé
Vocabulaire Electrotechnique International en ligne.
ƒ Service Clients: www.iec.ch/webstore/custserv/custserv_entry-f.htm
Si vous désirez nous donner des commentaires sur cette publication ou si vous avez des questions, visitez le FAQ du
Service clients ou contactez-nous:
Email: [e-mail]
Tél.: [phone]
Fax: [phone]
IEC 80601-2-35
Edition 1.0 2009-10
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
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 chauffants et destinés au réchauffage des patients en
usage médical
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
PRICE CODE
INTERNATIONALE
XB
CODE PRIX
ICS 11.040.01; 11.140 ISBN 978-2-88910-782-7

– 2 – 80601-2-35  IEC:2009
CONTENTS
FOREWORD . 4

INTRODUCTION . 7

201.1 Scope, object and related standards . 8

201.2 Normative references . 10

201.3 Terms and definitions. 10

201.4 General requirements . 13

201.5 General requirements for testing ME EQUIPMENT . 14
201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 14
201.7 ME EQUIPMENT identification, marking and documents . 14
201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 17
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 22
201.10 Protection against unwanted and excessive radiation HAZARDS . 24
201.11 Protection against excessive temperatures and other HAZARDS . 24
201.12 Accuracy of controls and instruments and protection against hazardous
outputs . 27
201.13 HAZARDOUS SITUATIONS and fault conditions . 32
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 37
201.15 Construction of ME EQUIPMENT . 37
201.16 ME SYSTEMS . 41
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 41
202 Electromagnetic compatibility – Requirements and tests . 42
208 General requirements, tests and guidance for ALARM SYSTEMS in MEDICAL
ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS. 42
210 * Requirements for the development of physiologic closed-loop controllers . 42
Annex D (informative) Symbols on marking . 43
Annex AA (informative) Particular guidance and rationale . 44
Annex BB (normative) Determination of the LAGGING MATERIAL . 55
Annex CC (normative) *Determination of heat transfer towards the PATIENT . 56
Annex DD (normative) *Determination of heat transfer away from the PATIENT . 58

Annex EE (normative) Conditions of adequate heat discharge . 59
Annex FF (normative) Test procedure for maximum CONTACT SURFACE TEMPERATURE
for FORCED AIR DEVICES . 60
Annex GG (normative) Test procedure for maximum CONTACT SURFACE TEMPERATURE
for FORCED AIR DEVICES under SINGLE FAULT CONDITION. 62
Annex HH (normative) Safety test procedure for average CONTACT SURFACE
TEMPERATURE for FORCED AIR DEVICES . 63
Bibliography . 65
Index of defined terms used in this particular standard. 66

Figure 201.101 – Positioning of temperature sensors on the contact surface of the
heated area of a HEATING DEVICE (see 201.12.4.101 and 201.12.4.105) . 11

80601-2-35  IEC:2009 – 3 –
Figure 201.102 – Example of the positioning of temperature sensors on the contact

surface of the heated areas of a HEATING DEVICE having more than one separately

heated area . 11

Figure 201.103 a) – Apparatus for the spark ignition test – Detail A: The apparatus

(see 201.8.8.4.101) . 19

Figure 201.103 b) – Apparatus for the spark ignition test – Detail B: Lower member of

mask . 20

Figure 201.103 c) – Apparatus for the spark ignition test – Detail C: Upper member of

mask . 20

Figure 201.103 – Apparatus for the spark ignition test . 20

Figure 201.104 – Ramp for the impact test on PADS . 23
Figure 201.105 – Partial covering conditions . 25
Figure 201.106 – Method of folding BLANKETS . 34
Figure 201.107 – Examples of folds . 36
Figure 201.108 – Positions of a BLANKET for the RUCK-RESISTANCE test. 41
Figure HH.1 – Sensor locations – Average CONTACT SURFACE TEMPERATURE . 64

Table 201.101 – *Additional ESSENTIAL PERFORMANCE requirements . 13
Table 201.102 – Temperature limits in dependency to time . 38

– 4 – 80601-2-35  IEC:2009
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

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 certi
...

IEC 80601-2-35
Edition 1.1 2016-04
CONSOLIDATED VERSION
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
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 chauffants et destinés au réchauffage des patients en
usage médical
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.: [phone]
3, rue de Varembé [e-mail]
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
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IEC 80601-2-35
Edition 1.1 2016-04
CONSOLIDATED VERSION
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
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 chauffants et destinés au réchauffage des patients en
usage médical
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 11.040.01 ISBN 978-2-8322-3384-9
IEC 80601-2-35
Edition 1.1 2016-04
CONSOLIDATED VERSION
REDLINE VERSION
VERSION REDLINE
colour
inside
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 chauffants et destinés au réchauffage des patients en
usage médical
– 2 – IEC 80601-2-35:2009+AMD1:2016 CSV
© IEC 2016
CONTENTS
FOREWORD. 4
INTRODUCTION . 7
201.1 Scope, object and related standards . 8
201.2 Normative references . 10
201.3 Terms and definitions . 10
201.4 General requirements . 13
201.5 General requirements for testing ME EQUIPMENT . 14
201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 14
201.7 ME EQUIPMENT identification, marking and documents. 14
201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 17
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 22
201.10 Protection against unwanted and excessive radiation HAZARDS . 24
201.11 Protection against excessive temperatures and other HAZARDS . 24
201.12 Accuracy of controls and instruments and protection against hazardous
outputs . 27
201.13 HAZARDOUS SITUATIONS and fault conditions . 32
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 37
201.15 Construction of ME EQUIPMENT . 37
201.16 ME SYSTEMS . 41
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 41
202 Electromagnetic compatibility – Requirements and tests . 42
208 General requirements, tests and guidance for ALARM SYSTEMS in MEDICAL
ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS . 42
210 * Requirements for the development of physiologic closed-loop controllers . 42
Annex D (informative) Symbols on marking . 43
Annex AA (informative) Particular guidance and rationale . 44
Annex BB (normative) Determination of the LAGGING MATERIAL . 56
Annex CC (normative) *Determination of heat transfer towards the PATIENT . 57
Annex DD (normative) *Determination of heat transfer away from the PATIENT . 59
Annex EE (normative) Conditions of adequate heat discharge . 60
Annex FF (normative) Test procedure for maximum CONTACT SURFACE TEMPERATURE
for FORCED AIR DEVICES . 61
Annex GG (normative) Test procedure for maximum CONTACT SURFACE TEMPERATURE
for FORCED AIR DEVICES under SINGLE FAULT CONDITION . 63
Annex HH (normative) Safety test procedure for average CONTACT SURFACE
TEMPERATURE for FORCED AIR DEVICES . 64
Bibliography . 66
Index of defined terms used in this particular standard . 67
Figure 201.101 – Positioning of temperature sensors on the contact surface of the
heated area of a HEATING DEVICE (see 201.12.4.101 and 201.12.4.105) . 11

© IEC 2016
Figure 201.102 – Example of the positioning of temperature sensors on the contact
surface of the heated areas of a HEATING DEVICE having more than one separately
heated area . 11
Figure 201.103 a) – Apparatus for the spark ignition test – Detail A: The apparatus
(see 201.8.8.4.101) . 19
Figure 201.103 b) – Apparatus for the spark ignition test – Detail B: Lower member of
mask . 20
Figure 201.103 c) – Apparatus for the spark ignition test – Detail C: Upper member of
mask . 20
Figure 201.103 – Apparatus for the spark ignition test . 20
Figure 201.104 – Ramp for the impact test on PADS . 23
Figure 201.105 – Partial covering conditions . 25
Figure 201.106 – Method of folding BLANKETS . 34
Figure 201.107 – Examples of folds . 36
Figure 201.108 – Positions of a BLANKET for the RUCK-RESISTANCE test . 41
Figure HH.1 – Sensor locations – Average CONTACT SURFACE TEMPERATURE . 65
Table 201.101 – *Additional ESSENTIAL PERFORMANCE requirements . 13
Table 201.102 – Temperature limits in dependency to time . 38

– 4 – IEC 80601-2-35:2009+AMD1:2016 CSV
© IEC 2016
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
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
...