IEC 60601-2-35:2020
(Main)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
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 60601-2-35:2020 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of HEATING DEVICES using BLANKETS, PADS or MATTRESSES in medical use, also referred to as ME EQUIPMENT. HEATING DEVICES intended to prewarm a bed are included in the scope of this document.
If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant.
If a clause or subclause is specifically intended to be applicable to a specifically defined type of ME EQUIPMENT, as is the case with FORCED AIR DEVICES, then the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant.
HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this document are not covered by specific requirements in this document, except in 7.2.13 and 8.4.1 of the general standard.
IEC 60601-2-35:2020 does not apply to:
- HEATING DEVICES intended for physiotherapy;
- INFANT RADIANT WARMERS; for information, see IEC 60601-2-21;
- INFANT INCUBATORS; for information, see IEC 60601-2-19;
- INFANT TRANSPORT INCUBATORS, for information, see IEC 60601-2-20;
- cooling devices.
IEC 60601-2-35:2020 cancels and replaces IEC 80601-2-35 published in 2009 and Amendment 1:2016. This edition constitutes a technical revision.
IEC 60601-2-35:2020 includes the following significant technical change with respect to the previous edition: re-dating of normative references.
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
L'IEC 60601-2-35:2020 s’applique à la SECURITE DE BASE et aux PERFORMANCES ESSENTIELLES des DISPOSITIFS DE RECHAUFFAGE utilisant des COUVERTURES, des COUSSINS ou des MATELAS en usage médical, également désignés sous le terme APPAREILS EM. Les DISPOSITIFS DE RECHAUFFAGE destinés à préchauffer un lit sont compris dans le domaine d'application du présent document.
Si un article ou un paragraphe est spécifiquement destiné à être applicable uniquement aux APPAREILS EM ou uniquement aux SYSTEMES EM, le titre et le contenu de cet article ou de ce paragraphe l'indiquent. Si cela n'est pas le cas, l'article ou le paragraphe s'applique à la fois aux APPAREILS EM et aux SYSTEMES EM, selon le cas.
Si un article ou un paragraphe est spécifiquement destiné à être applicable à un type spécifiquement défini d’APPAREIL EM, comme c’est le cas avec les DISPOSITIFS A AIR PULSE, alors le titre et le contenu de cet article ou de ce paragraphe l’indiquent. Si cela n'est pas le cas, l'article ou le paragraphe s'applique à la fois aux APPAREILS EM et aux SYSTEMES EM, selon le cas.
Les DANGERS inhérents à la fonction physiologique prévue des APPAREILS EM ou des SYSTEMES EM dans le cadre du domaine d'application du présent document ne sont pas couverts par des exigences spécifiques contenues dans le présent document, à l'exception de 7.2.13 et de 8.4.1 de la norme générale.
Le présent document ne s'applique pas aux:
– DISPOSITIFS DE RECHAUFFAGE destinés à la physiothérapie;
– INCUBATEURS RADIANTS POUR NOUVEAU-NES; voir l’IEC 60601-2-21 à titre informatif;
– INCUBATEURS POUR NOUVEAU-NES; voir l’IEC 60601-2-19 à titre informatif;
– incubateurs de transport POUR NOUVEAU-NES; voir l’IEC 60601-2-20 à titre informatif;
– dispositifs de refroidissement.
L'IEC 60601-2-35:2020 annule et remplace l’IEC 80601-2-35 parue en 2009 et son Amendement 1 (2016).
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IEC 60601-2-35 ®
Edition 2.0 2020-09
INTERNATIONAL
STANDARD
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
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
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copyright or have an enquiry about obtaining additional rights to this publication, please contact the address below or
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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.
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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.
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IEC 60601-2-35 ®
Edition 2.0 2020-09
INTERNATIONAL
STANDARD
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
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
ICS 11.040.01; 11.140 ISBN 978-2-8322-8723-1
– 2 – IEC 60601-2-35:2020 © IEC 2020
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 . 18
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 24
201.10 Protection against unwanted and excessive radiation HAZARDS . 26
201.11 Protection against excessive temperatures and other HAZARDS . 26
201.12 Accuracy of controls and instruments and protection against hazardous
outputs . 28
201.13 HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT . 33
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 38
201.15 Construction of ME EQUIPMENT . 38
201.16 ME SYSTEMS . 42
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 42
202 ELECTROMAGNETIC DISTURBANCES – Requirements and tests . 43
208 General requirements, tests and guidance for ALARM SYSTEMS IN MEDICAL
ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS . 43
210 * Requirements for the development of PHYSIOLOGIC CLOSED-LOOP CONTROLLERS . 43
Annexes . 44
Annex D (informative) Symbols on marking . 44
Annex AA (informative) Particular guidance and rationale . 45
Annex BB (normative) Determination of the LAGGING MATERIAL . 57
Annex CC (normative) * Determination of heat transfer towards the PATIENT . 58
Annex DD (normative) * Determination of heat transfer away from the PATIENT . 60
Annex EE (normative) CONDITIONS OF ADEQUATE HEAT DISCHARGE . 61
Annex FF (normative) Test procedure for maximum CONTACT SURFACE TEMPERATURE
for FORCED AIR DEVICES . 62
Annex GG (normative) Test procedure for maximum CONTACT SURFACE TEMPERATURE
for FORCED AIR DEVICES under SINGLE FAULT CONDITION. 64
Annex HH (normative) Safety test procedure for average CONTACT SURFACE
TEMPERATURE for FORCED AIR DEVICES . 65
Bibliography . 67
Index of defined terms used in this document . 69
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
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 . 12
Figure 201.103 – Apparatus for the spark ignition test . 22
Figure 201.104 – Ramp for the impact test on PADS . 24
Figure 201.105 – Partial covering conditions . 26
Figure 201.106 – Method of folding BLANKETS . 35
Figure 201.107 – Examples of folds . 37
Figure 201.108 – Positions of a BLANKET for the RUCK-RESISTANCE test. 42
Figure AA.1 – Illustration of the main requirements of this document . 45
Figure HH.1 – Sensor locations – Average CONTACT SURFACE TEMPERATURE . 66
Table 201.101 – * Additional ESSENTIAL PERFORMANCE requirements . 14
Table 201.102 – Temperature limits in dependency to time . 39
– 4 – IEC 60601-2-35:2020 © IEC 2020
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.
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6) All users should ensure that they have the latest edition of this publication.
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9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of
patent rights. IEC shall not be held responsible for identifying any or all such patent rights.
International Standard IEC 60601-2-35 has been prepared by IEC technical committee 62D:
Electromedical equipment, of IEC technical committee 62: Electrical equipment in medical
practice.
This second edition cancels and replaces IEC 80601-2-35 published in 2009 and
Amendment 1:2016.
The text of this particular standard is based on the following documents:
FDIS Report on voting
62D/1765/FDIS 62D/1777/RVD
Full information on the voting for the approval of this International Standard can be found in
the report on voting indicated in the above table.
This document has been drafted in accordance with the ISO/IEC Directives, Part 2.
In this document, the following print types are used:
– requirements and definitions: roman type;
– test specifications: italic type;
– informative material appearing outside of tables, such as notes, examples and references: in smaller type.
Normative text of tables is also in a smaller type;
– TERMS DEFINED IN CLAUSE 3 OF THE GENERAL STANDARD, IN THIS PARTICULAR STANDARD OR AS
NOTED: SMALL CAPITALS.
In referring to the structure of this document, the term
– "clause" means one of the seventeen numbered divisions within the table of contents,
inclusive of all subdivisions (e.g. Clause 7 includes subclauses 7.1, 7.2, etc.);
– "subclause" means a numbered subdivision of a clause (e.g. 7.1, 7.2 and 7.2.1 are all
subclauses of Clause 7).
References to clauses within this document are preceded by the term "Clause" followed by
the clause number. References to subclauses within this particular standard are by number
only.
In this document, the conjunctive "or" is used as an "inclu
...
IEC 60601-2-35 ®
Edition 2.0 2020-09
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 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
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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.
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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.
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IEC 60601-2-35 ®
Edition 2.0 2020-09
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 et destinés au réchauffage des patients en usage
médical
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 11.040.01; 11.140 ISBN 978-2-8322-1015-8
– 2 – IEC 60601-2-35:2020 © IEC 2020
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 . 18
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 24
201.10 Protection against unwanted and excessive radiation HAZARDS . 26
201.11 Protection against excessive temperatures and other HAZARDS . 26
201.12 Accuracy of controls and instruments and protection against hazardous
outputs . 28
201.13 HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT . 33
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 38
201.15 Construction of ME EQUIPMENT . 38
201.16 ME SYSTEMS . 42
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 42
202 ELECTROMAGNETIC DISTURBANCES – Requirements and tests . 43
208 General requirements, tests and guidance for ALARM SYSTEMS IN MEDICAL
ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS . 43
210 * Requirements for the development of PHYSIOLOGIC CLOSED-LOOP CONTROLLERS . 43
Annexes . 44
Annex D (informative) Symbols on marking . 44
Annex AA (informative) Particular guidance and rationale . 45
Annex BB (normative) Determination of the LAGGING MATERIAL . 57
Annex CC (normative) * Determination of heat transfer towards the PATIENT . 58
Annex DD (normative) * Determination of heat transfer away from the PATIENT . 60
Annex EE (normative) CONDITIONS OF ADEQUATE HEAT DISCHARGE . 61
Annex FF (normative) Test procedure for maximum CONTACT SURFACE TEMPERATURE
for FORCED AIR DEVICES . 62
Annex GG (normative) Test procedure for maximum CONTACT SURFACE TEMPERATURE
for FORCED AIR DEVICES under SINGLE FAULT CONDITION. 64
Annex HH (normative) Safety test procedure for average CONTACT SURFACE
TEMPERATURE for FORCED AIR DEVICES . 65
Bibliography . 67
Index of defined terms used in this document . 69
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
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 . 12
Figure 201.103 – Apparatus for the spark ignition test . 22
Figure 201.104 – Ramp for the impact test on PADS . 24
Figure 201.105 – Partial covering conditions . 26
Figure 201.106 – Method of folding BLANKETS . 35
Figure 201.107 – Examples of folds . 37
Figure 201.108 – Positions of a BLANKET for the RUCK-RESISTANCE test. 42
Figure AA.1 – Illustration of the main requirements of this document . 45
Figure HH.1 – Sensor locations – Average CONTACT SURFACE TEMPERATURE . 66
Table 201.101 – * Additional ESSENTIAL PERFORMANCE requirements . 14
Table 201.102 – Temperature limits in dependency to time . 39
– 4 – IEC 60601-2-35:2020 © IEC 2020
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 nation
...
IEC 60601-2-35 ®
Edition 2.1 2023-12
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 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 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.
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IEC 60601-2-35 ®
Edition 2.1 2023-12
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 et destinés au réchauffage des
patients en usage médical
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 11.040, 11.140.01 ISBN 978-2-8322-8119-2
IEC 60601-2-35 ®
Edition 2.1 2023-12
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 et destinés au réchauffage des
patients en usage médical
– 2 – IEC 60601-2-35:2020+AMD1:2023 CSV
© IEC 2023
CONTENTS
FOREWORD . 4
INTRODUCTION . 7
INTRODUCTION to Amendment 1 . 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 . 18
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 24
201.10 Protection against unwanted and excessive radiation HAZARDS . 26
201.11 Protection against excessive temperatures and other HAZARDS . 26
201.12 Accuracy of controls and instruments and protection against hazardous
outputs . 28
201.13 HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT . 33
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 38
201.15 Construction of ME EQUIPMENT . 38
201.16 ME SYSTEMS . 42
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 42
202 ELECTROMAGNETIC DISTURBANCES – Requirements and tests . 43
208 General requirements, tests and guidance for ALARM SYSTEMS IN MEDICAL
ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS. 43
210 * Requirements for the development of PHYSIOLOGIC CLOSED-LOOP CONTROLLERS . 43
Annexes . 44
Annex D (informative) Symbols on marking . 44
Annex AA (informative) Particular guidance and rationale . 45
Annex BB (normative) Determination of the LAGGING MATERIAL . 57
Annex CC (normative) * Determination of heat transfer towards the PATIENT . 58
Annex DD (normative) * Determination of heat transfer away from the PATIENT . 60
Annex EE (normative) CONDITIONS OF ADEQUATE HEAT DISCHARGE . 61
Annex FF (normative) Test procedure for maximum CONTACT SURFACE TEMPERATURE
for FORCED AIR DEVICES . 62
Annex GG (normative) Test procedure for maximum CONTACT SURFACE TEMPERATURE
for FORCED AIR DEVICES under SINGLE FAULT CONDITION. 64
Annex HH (normative) Safety test procedure for average CONTACT SURFACE
TEMPERATURE for FORCED AIR DEVICES . 65
Bibliography . 67
Index of defined terms used in this document . 69
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 2023
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 . 12
Figure 201.103 – Apparatus for the spark ignition test . 22
Figure 201.104 – Ramp for the impact test on PADS . 24
Figure 201.105 – Partial covering conditions . 26
Figure 201.106 – Method of folding BLANKETS . 35
Figure 201.107 – Examples of folds . 37
Figure 201.108 – Positions of a BLANKET for the RUCK-RESISTANCE RUCK resistance test . 42
Figure AA.1 – Illustration of the main requirements of this document . 45
Figure HH.1 – Sensor locations – Average CONTACT SURFACE TEMPERATURE . 66
Table 201.101 – * Additional ESSENTIAL PERFORMANCE requirements . 14
Table 201.102 – Temperature limits in dependency to time . 39
– 4 – IEC 60601-2-35:2020+AMD1:2023 CSV
© 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
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 near
...
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