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

Gives methods for measuring and specifying those characteristics of audio infra-red (IR) transmission systems for conference and similar systems which are not covered by part 1. Replaces chapter 2 of IEC 60764.

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 chauffants et destinés au réchauffage des patients en usage médical

Fournit des méthodes de mesure et de spécification des caractéristiques des systèmes de transmission audio infrarouges (IR) pour les systèmes de conférence et systèmes similaires qui ne sont pas couverts par la partie 1. Remplace le chapitre 2 de la CEI 60764.

General Information

• Status: Replaced
• Publication Date: 28-Apr-2016
• ICS: 01 - GENERALITIES. TERMINOLOGY. STANDARDIZATION. DOCUMENTATION
• ICS: 11.040.01 - Medical equipment in general
• ICS: 33.160.01 - Audio, video and audiovisual systems in general
• 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
• Completion Date: 21-Sep-2020

Relations

• 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
• Amends: 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
• Effective Date: 05-Sep-2023

Standards Content (Sample)

IEC 80601-2-35
Edition 2.0 2016-04
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
AM ENDMENT 1
AM ENDEMENT 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 chauffants et destinés au réchauffage des patients en
usage médical
IEC 80601-2-35:2009-10/AMD1:2016-04(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 Central Office Tel.: [phone]
3, rue de Varembé Fax: [phone]
CH-1211 Geneva 20 [e-mail]
Switzerland 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.

IEC Catalogue - webstore.iec.ch/catalogue Electropedia - www.electropedia.org
The stand-alone application for consulting the entire The world's leading online dictionary of electronic and
bibliographical information on IEC International Standards, electrical terms containing 20 000 terms and definitions in
Technical Specifications, Technical Reports and other English and French, with equivalent terms in 15 additional
documents. Available for PC, Mac OS, Android Tablets and languages. Also known as the International Electrotechnical
iPad. Vocabulary (IEV) online.

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The advanced search enables to find IEC publications by a 65 000 electrotechnical terminology entries in English and
variety of criteria (reference number, text, technical French extracted from the Terms and Definitions clause of
committee,…). It also gives information on projects, replaced IEC publications issued since 2002. Some entries have been
and withdrawn publications. collected from earlier publications of IEC TC 37, 77, 86 and

CISPR.
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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.

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bibliographiques sur les Normes internationales,
électriques. Il contient 20 000 termes et définitions en anglais
Spécifications techniques, Rapports techniques et autres
et en français, ainsi que les termes équivalents dans 15
documents de l'IEC. Disponible pour PC, Mac OS, tablettes
langues additionnelles. Egalement appelé Vocabulaire
Android et iPad.
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en utilisant différents critères (numéro de référence, texte, et en français, extraites des articles Termes et Définitions des
comité d’études,…). Elle donne aussi des informations sur les publications IEC parues depuis 2002. Plus certaines entrées
projets et les publications remplacées ou retirées. antérieures extraites des publications des CE 37, 77, 86 et

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IEC 80601-2-35
Edition 2.0 2016-04
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
AM ENDMENT 1
AM ENDEMENT 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 chauffants et destinés au réchauffage des patients en

usage médical
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 11.040.01 ISBN 978-2-8322-3345-0

– 2 – IEC 80601-2-35:2009/AMD1:2016
© IEC 2016
FOREWORD
This amendment has been prepared by a joint working group of IEC subcommittee 62D:
Electromedical equipment of IEC technical committee 62: Electrical equipment in medical
practice and ISO subcommittee TC121/SC1: Breathing attachments and anaesthetic
machines, of ISO technical committee 121: Anaesthetic and respiratory equipment.
It is published as a double logo standard.
The text of this amendment is based on the following documents:
FDIS Report on voting
62D/1328/FDIS 62D/1355/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 standard 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 website 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.
_____________
INTRODUCTION
Replace, in the second paragraph, “IEC 60601-1 (third edition, 2005)” by “IEC 60601-1”.
201.1 Scope, object and related standards
Replace, in footnote 1), “IEC 60601-1:2005” by “IEC 60601-1”.
201.2 Normative references
Replace “IEC 60601-1-2:2007” by “IEC 60601-1-2”.
Replace “IEC 60601-1-8:2006” by “IEC 60601-1-8”.
Replace “IEC 60601-1-10:2007” by “IEC 60601-1-10”.

© IEC 2016
Delete the following reference:
ISO 3743-1:1994, Acoustics – Determination of sound power levels of noise sources –
Engineering methods for small, movable sources in reverberant fields – Part 1: Comparison
method for hard-walled test rooms
201.3 Terms and definitions
Replace, in the first paragraph, “IEC 60601-1:2005” by “IEC 60601-1”.
201.7.2.1.101.2 CONTROLLERS
Replace the text in item a) by the following new text:
a) The HOSE shall be marked within 15 cm of the NOZZLE to caution that the NOZZLE needs to
be connected to a BLANKET. The following statement and the safety sign ISO 7010-M002
(see IEC 60601-1, Table D.2, safety sign 10) shall accompany the “NO FREE HOSING”
safety sign of IEC 60878, shown in Annex D of this particular standard:
201.8.5.1.2.101 * Additional requirements for MEANS OF PATIENT PROTECTION (MOPP)
Replace the first two paragraphs by the following:
The electrical circuit within the APPLIED PART shall be isolated from earth by at least one MOPP
and from MAINS by at least two MOPP. Where a transformer is used to achieve this isolation, it
need not meet 15.5.3.
201.12.3.104 Disconnection or short-circuiting of sensors ALARM CONDITION
Replace the second paragraph by the following:
HEATING DEVICE shall be equipped with an ALARM SYSTEM that includes at least a MEDIUM
The
PRIORITY TECHNICAL ALARM CONDITION for HIGH HEAT TRANSFER DEVICES and at least a LOW
PRIORITY ALARM for LOW HEAT TRANSFER DEVICES and FORCED AIR DEVICES that indicates when
leads to either the temperature control sensors or the THERMAL CUT-OUT sensors are damaged
or otherwise disconnected from the control unit.
202 Electromagnetic compatibility – Requirements and tests
Replace, in the first paragraph, “IEC 60601-1-2:2007” by “IEC 60601-1-2”.
202.6.2.3 Radiated RF electromagnetic fields
Replace the number, title and entire text by the following new subclause number, title and
text:
202.8.9 IMMUNITY TEST LEVELS
Addition:
For radiated radio-frequency electromagnetic fields, the HEATING DEVICE and/or system shall

– 4 – IEC 80601-2-35:2009/AMD1:2016
© IEC 2016
– continue to perform its intended function as specified by the MANUFACTURER at the level up
to 3 V/m for the frequency range of the collateral standard of EMC.
NOTE A HEATING DEVICE is not considered to be used in a HOME HEALTHCARE ENVIRONMENT.
208 General requirements, tests and guidance for ALARM SYSTEMS IN MEDICAL
ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS
Replace, in the first paragraph, “IEC 60601-1-8:2006” by “IEC 60601-1-8”.
210 Requirements for the development of physiologic closed-loop controllers
Replace both instances of “IEC 60601-1-10:2007” by “IEC 60601-1-10”.

Annex AA
(informative)
Particular guidance and rationale

Add, immediately after the annex title, the following new text and figure:
AA.1 Requirements and the safety concept of this standard
Compliance with the minimum safety requirements specified in this particular standard is
predominantly checked by measurement of physical quantities such as the temperature. In
most cases the spatial location of the measuring site or the temporal development of the
quantity is of interest. Therefore, the expert group of this standard considered it helpful to
provide a synopsis of the requirements of this standard. Hence, Figure AA.1 illustrates the
requirements and their schematic measuring sites or expected temporal development. The
requirements as given by their clauses are set in brackets.

© IEC 2016
(201.12.4.105)
LHT (201.12.4.101)
±0,7 °C
±2,5 °C
Indication of CONTACT SURFACE
TEMPERATURE RANGE 20 °C to 42 °C
(201.12.4.105)
HHT (201.12.4.101)
±1 °C
T T
2 3
T
R
T T
1 4
1 °C max. (201.7.4.2.101)
±1 °C AND ≤ 41 °C
(201.12.4.104)
Setting of control
HHT
temperature
LHT
≤ 35 °C to ≥ 38 °C
AND ≤ 41 °C
(201.12.1.101.1)
41 °C Temperature (°C)
Overshoot (201.12.4.103)
Maximum 40 °C
CONTACT
SURFACE
TEMPERATURE
Maximum
1 °C
+1 °C
in SINGLE FAULT
CONTACT
CONDITION
SURFACE
(201.11.1.2.1.101.3)
TEMPERATURE
−1 °C Set point
in
+
NORMAL
±0,5 °C for HHT
THERMAL
CONDITION
±1,0 °C for LHT
CUT-OUT
(201.11.1.2.1.101.1)
(201.12.4.102)
Temperature
(201.15.4.2.1.101)
36 °C
alarm
±1 °C
(201.12.3.102)
(HHT only)
LHT – LOW HEAT TRANSFER Time
HHT – HIGH HEAT TRANSFER
IEC
NOTE Numbers in brackets indicate the relevant subclauses.
Figure AA.1 – Illustration of the main requirements of this standard
AA.2 Particular guidance
Subclause 201.11.1.2.1.102.1 – Maximum CONTACT SURFACE TEMPERATURE in NORMAL
CONDITION
Add, after the existing text, the following new text:
The CONTACT SURFACE TEMPERATURE of HEATING DEVICES may rise when combined with other
heat sources such as heating BLANKETS or PADS. Hence, it is important to specifically consider
the impact of such additional heat sources in the RISK MANAGEMENT.
Subclause 202.6.2 – IMMUNITY
Delete the entire reference to subclause 202.6.2 and its rationale.

– 6 – IEC 80601-2-35:2009/AMD1:2016
© IEC 2016
Subclause 210 – Requirements for the development of physiologic closed-loop
controllers
Replace, in the first paragraph, “IEC 60601-1-10-1” by “IEC 60601-1-10”.

Annex FF
(normative)
Test procedure for maximum CONTACT SURFACE
TEMPERATURE for FORCED AIR DEVICES

Replace the entire existing text of item a) by the following new text:
a) LAGGING MATERIAL
The LAGGING MATERIAL has the following characteristics:
Material: Polyurethane or polystyrene insulation material;
Thermal resistance: A minimum R-Value rating of 10 when tested in accordance with
ASTM C578 [8];
Size: Not less than the size of the active heating area of the test blanket
and not less than 25 mm thick.

Bibliography
Delete “:2009” in references [10], [11] and [12].

Index of defined terms used in this pa
...

IEC 80601-2-35
Edition 1.0 2016-04
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
AM ENDMENT 1
AM ENDEMENT 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 chauffants et destinés au réchauffage des patients en
usage médical
IEC 80601-2-35:2009-10/AMD1:2016-04(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 Central Office Tel.: [phone]
3, rue de Varembé Fax: [phone]
CH-1211 Geneva 20 [e-mail]
Switzerland 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.
IEC Catalogue - webstore.iec.ch/catalogue Electropedia - www.electropedia.org
The stand-alone application for consulting the entire The world's leading online dictionary of electronic and
bibliographical information on IEC International Standards, electrical terms containing 20 000 terms and definitions in
Technical Specifications, Technical Reports and other English and French, with equivalent terms in 15 additional
documents. Available for PC, Mac OS, Android Tablets and languages. Also known as the International Electrotechnical
iPad. Vocabulary (IEV) online.
IEC publications search - www.iec.ch/searchpub IEC Glossary - std.iec.ch/glossary
The advanced search enables to find IEC publications by a 65 000 electrotechnical terminology entries in English and
variety of criteria (reference number, text, technical French extracted from the Terms and Definitions clause of
committee,…). It also gives information on projects, replaced IEC publications issued since 2002. Some entries have been
and withdrawn publications. collected from earlier publications of IEC TC 37, 77, 86 and
CISPR.
IEC Just Published - webstore.iec.ch/justpublished
Stay up to date on all new IEC publications. Just Published IEC Customer Service Centre - webstore.iec.ch/csc
details all new publications released. Available online and If you wish to give us your feedback on this publication or
also once a month by email. need further assistance, please contact the Customer Service
Centre: [e-mail].
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.

Catalogue IEC - webstore.iec.ch/catalogue Electropedia - www.electropedia.org
Application autonome pour consulter tous les renseignements
Le premier dictionnaire en ligne de termes électroniques et
bibliographiques sur les Normes internationales,
électriques. Il contient 20 000 termes et définitions en anglais
Spécifications techniques, Rapports techniques et autres
et en français, ainsi que les termes équivalents dans 15
documents de l'IEC. Disponible pour PC, Mac OS, tablettes
langues additionnelles. Egalement appelé Vocabulaire
Android et iPad.
Electrotechnique International (IEV) en ligne.
Recherche de publications IEC - www.iec.ch/searchpub
Glossaire IEC - std.iec.ch/glossary
La recherche avancée permet de trouver des publications IEC 65 000 entrées terminologiques électrotechniques, en anglais
en utilisant différents critères (numéro de référence, texte, et en français, extraites des articles Termes et Définitions des
comité d’études,…). Elle donne aussi des informations sur les publications IEC parues depuis 2002. Plus certaines entrées
projets et les publications remplacées ou retirées. antérieures extraites des publications des CE 37, 77, 86 et
CISPR de l'IEC.
IEC Just Published - webstore.iec.ch/justpublished
Service Clients - webstore.iec.ch/csc
Restez informé sur les nouvelles publications IEC. Just
Published détaille les nouvelles publications parues. Si vous désirez nous donner des commentaires sur cette
Disponible en ligne et aussi une fois par mois par email. publication ou si vous avez des questions contactez-nous:
[e-mail].
IEC 80601-2-35
Edition 1.0 2016-04
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
AM ENDMENT 1
AM ENDEMENT 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 chauffants et destinés au réchauffage des patients en
usage médical
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 11.040.01 ISBN 978-2-8322-3345-0
– 2 – IEC 80601-2-35:2009/AMD1:2016

© IEC 2016
FOREWORD
This amendment has been prepared by a joint working group of IEC subcommittee 62D:

Electromedical equipment of IEC technical committee 62: Electrical equipment in medical

practice and ISO subcommittee TC121/SC1: Breathing attachments and anaesthetic
machines, of ISO technical committee 121: Anaesthetic and respiratory equipment.

It is published as a double logo standard.

The text of this amendment is based on the following documents:

FDIS Report on voting
62D/1328/FDIS 62D/1355/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 standard 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 website 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.
_____________
INTRODUCTION
Replace, in the second paragraph, “IEC 60601-1 (third edition, 2005)” by “IEC 60601-1”.

201.1 Scope, object and related standards
Replace, in footnote 1), “IEC 60601-1:2005” by “IEC 60601-1”.
201.2 Normative references
Replace “IEC 60601-1-2:2007” by “IEC 60601-1-2”.
Replace “IEC 60601-1-8:2006” by “IEC 60601-1-8”.
Replace “IEC 60601-1-10:2007” by “IEC 60601-1-10”.

© IEC 2016
Delete the following reference:

ISO 3743-1:1994, Acoustics – Determination of sound power levels of noise sources –
Engineering methods for small, movable sources in reverberant fields – Part 1: Comparison
method for hard-walled test rooms

201.3 Terms and definitions
Replace, in the first paragraph, “IEC 60601-1:2005” by “IEC 60601-1”.

201.7.2.1.101.2 CONTROLLERS
Replace the text in item a) by the following new text:
a) The HOSE shall be marked within 15 cm of the NOZZLE to caution that the NOZZLE needs to
be connected to a BLANKET. The following statement and the safety sign ISO 7010-M002
(see IEC 60601-1, Table D.2, safety sign 10) shall accompany the “NO FREE HOSING”
safety sign of IEC 60878, shown in Annex D of this particular standard:
201.8.5.1.2.101 * Additional requirements for MEANS OF PATIENT PROTECTION (MOPP)
Replace the first two paragraphs by the following:
The electrical circuit within the APPLIED PART shall be isolated from earth by at least one MOPP
and from MAINS by at least two MOPP. Where a transformer is used to achieve this isolation, it
need not meet 15.5.3.
201.12.3.104 Disconnection or short-circuiting of sensors ALARM CONDITION
Replace the second paragraph by the following:
HEATING DEVICE shall be equipped with an ALARM SYSTEM that includes at least a MEDIUM
The
PRIORITY TECHNICAL ALARM CONDITION for HIGH HEAT TRANSFER DEVICES and at least a LOW
PRIORITY ALARM for LOW HEAT TRANSFER DEVICES and FORCED AIR DEVICES that indicates when
leads to either the temperature control sensors or the THERMAL CUT-OUT sensors are damaged
or otherwise disconnected from the control unit.
202 Electromagnetic compatibility – Requirements and tests
Replace, in the first paragraph, “IEC 60601-1-2:2007” by “IEC 60601-1-2”.

202.6.2.3 Radiated RF electromagnetic fields
Replace the number, title and entire text by the following new subclause number, title and
text:
202.8.9 IMMUNITY TEST LEVELS
Addition:
For radiated radio-frequency electromagnetic fields, the HEATING DEVICE and/or system shall

– 4 – IEC 80601-2-35:2009/AMD1:2016

© IEC 2016
– continue to perform its intended function as specified by the MANUFACTURER at the level up

to 3 V/m for the frequency range of the collateral standard of EMC.

NOTE A HEATING DEVICE is not considered to be used in a HOME HEALTHCARE ENVIRONMENT.

208 General requirements, tests and guidance for ALARM SYSTEMS IN MEDICAL

ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS

Replace, in the first paragraph, “IEC 60601-1-8:2006” by “IEC 60601-1-8”.

210 Requirements for the development of physiologic closed-loop controllers

Replace both instances of “IEC 60601-1-10:2007” by “IEC 60601-1-10”.
Annex AA
(informative)
Particular guidance and rationale
Add, immediately after the annex title, the following new text and figure:
AA.1 Requirements and the safety concept of this standard
Compliance with the minimum safety requirements specified in this particular standard is
predominantly checked by measurement of physical quantities such as the temperature. In
most cases the spatial location of the measuring site or the temporal development of the
quantity is of interest. Therefore, the expert group of this standard considered it helpful to
provide a synopsis of the requirements of this standard. Hence, Figure AA.1 illustrates the
requirements and their schematic measuring sites or expected temporal development. The
requirements as given by their clauses are set in brackets.

© IEC 2016
(201.12.4.105)
LHT (201.12.4.101)
±0,7 °C
±2,5 °C
Indication of CONTACT SURFACE
TEMPERATURE RANGE 20 °C to 42 °C

(201.12.4.105)
HHT (201.12.4.101)
±1 °C
T T
2 3
T
R
T T
1 4
1 °C max. (201.7.4.2.101)
±1 °C AND ≤ 41 °C
(201.12.4.104)
Setting of control
HHT
temperature
LHT
≤ 35 °C to ≥ 38 °C
AND ≤ 41 °C
(201.12.1.101.1)
41 °C Temperature (°C)
Overshoot (201.12.4.103)
Maximum 40 °C
CONTACT
SURFACE
TEMPERATURE
Maximum
1 °C
+1 °C
in SINGLE FAULT
CONTACT
CONDITION
SURFACE
(201.11.1.2.1.101.3)
TEMPERATURE
−1 °C Set point
in
+
NORMAL
±0,5 °C for HHT
THERMAL
CONDITION
±1,0 °C for LHT
CUT-OUT
(201.11.1.2.1.101.1)
(201.12.4.102)
Temperature
(201.15.4.2.1.101)
36 °C
alarm
±1 °C
(201.12.3.102)
(HHT only)
LHT – LOW HEAT TRANSFER Time
HHT – HIGH HEAT TRANSFER
IEC
NOTE Numbers in brackets indicate the relevant subclauses.
Figure AA.1 – Illustration of the main requirements of this standard

AA.2 Particular guidance
Subclause 201.11.1.2.1.102.1 – Maximum CONTACT SURFACE TEMPERATURE in NORMAL
CONDITION
Add, after the existing text, the following new text:
The CONTACT SURFACE TEMPERATURE of HEATING DEVICES may rise when combined with other
heat sources such as heating BLANKETS or PADS. Hence, it is important to specifically consider
the impact of such additional heat sources in the RISK MANAGEMENT.
Subclause 202.6.2 – IMMUNITY
Delete the entire reference to subclause 202.6.2 and its rationale.

– 6 – IEC 80601-2-35:2009/AMD1:2016

© IEC 2016
Subclause 210 – Requirements for the development of physiologic closed-loop

controllers
Replace, in the first paragraph, “IEC 60601-1-10-1” by “IEC 60601-1-10”.

Annex FF
(normative)
Test procedure for maximum CONTACT SURFACE

TEMPERATURE for FORCED AIR DEVICES
Replace the entire existing text of item a) by the following new text:
a) LAGGING MATERIAL
The LAGGING MATERIAL has the following characteristics:
Material: Polyurethane or polystyrene insulation material;
Thermal resistance: A minimum R-Value rating of 10 when tested in accordance with
ASTM C578 [8];
Size: Not less than the size of the active heating area of the test blanket
and not less than 25 mm thick.
Bibliography
Delete “:2009” in references [10], [11] and [12].
Index of defined terms used in this parti
...