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).

General Information

Status
Published
Publication Date
20-Sep-2020
Current Stage
PPUB - Publication issued
Completion Date
21-Sep-2020
Ref Project

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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
IEC 60601-2-35:2020-09(en)
---------------------- Page: 1 ----------------------
THIS PUBLICATION IS COPYRIGHT PROTECTED
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---------------------- Page: 2 ----------------------
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

Warning! Make sure that you obtained this publication from an authorized distributor.

® Registered trademark of the International Electrotechnical Commission
---------------------- Page: 3 ----------------------
– 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

---------------------- Page: 4 ----------------------
IEC 60601-2-35:2020 © IEC 2020 – 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 .......................................................................................................................... 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

---------------------- Page: 5 ----------------------
– 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,

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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

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3) IEC Publications have the form of recommendations for international use and are accepted by IEC National

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between any IEC Publication and the corresponding national or regional publication shall be clearly indicated in

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6) All users should ensure that they have the latest edition of this publication.

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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) 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.
---------------------- Page: 6 ----------------------
IEC 60601-2-35:2020 © IEC 2020 – 5 –
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 "inclusive or" so a statement is true if any

combination of the conditions is true.

The verbal forms used in this document conform to usage described in Clause 7 of the

ISO/IEC Directives, Part 2. For the purposes of this document, the auxiliary verb:

– "shall" means that compliance with a requirement or a test is mandatory for compliance

with this document;

– "should" means that compliance with a requirement or a test is recommended but is not

mandatory for compliance with this document;

– "may" is used to describe a permissible way to achieve compliance with a requirement or

test.

An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title

indicates that there is guidance or rationale related to that item in Annex AA.

A list of all parts of the 60601 International Standard, published under the general title

Medical electrical equipment, can be found on the IEC website.
---------------------- Page: 7 ----------------------
– 6 – IEC 60601-2-35:2020 © IEC 2020

The committee has decided that the contents of this document will remain unchanged until the

stability date indicated on the IEC website under "http://webstore.iec.ch" in the data related to

the specific document. At this date, the document will be
• reconfirmed,
• withdrawn,
• replaced by a revised edition, or
• amended.

NOTE The attention of users of this document is drawn to the fact that equipment manufacturers and testing

organizations may need a transitional period following publication of a new, amended or revised IEC 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 committees that the content of this publication be adopted for

implementation nationally not earlier than 3 years from the date of publication.

IMPORTANT – The "colour inside" logo on the cover page of this publication indicates

that it contains colours which are considered to be useful for the correct understanding

of its contents. Users should therefore print this publication using a colour printer.

---------------------- Page: 8 ----------------------
IEC 60601-2-35:2020 © IEC 2020 – 7 –
INTRODUCTION

The minimum safety requirements specified in this particular standard are considered to

provide for a practical degree of safety in the operation for HEATING DEVICES using BLANKETS,

PADS or MATTRESSES and intended for heating in medical use.

While K (degree Kelvin) is the recognized unit and symbol for absolute temperature and

temperature difference, °C has been used throughout this document because all

measurements are commonly made using equipment marked with the Celsius temperature

scale.
---------------------- Page: 9 ----------------------
– 8 – IEC 60601-2-35:2020 © IEC 2020
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
201.1 Scope, object and related standards
Clause 1 of the general standard applies, except as follows:
201.1.1 * Scope
Replacement:

This part of 60601 International Standard 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.
NOTE See also 4.2 of the general standard.
This document does not apply to:
– HEATING DEVICES intended for physiotherapy;
– INFANT RADIANT WARMERS; for information, see IEC 60601-2-21 [1] ;
– INFANT INCUBATORS; for information, see IEC 60601-2-19 [2];
– INFANT TRANSPORT INCUBATORS, for information, see IEC 60601-2-20 [3];
– cooling devices.
_____________

The general standard is IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012, Medical electrical equipment –

Part 1: General requirements for basic safety and essential performance.
Figures in square brackets refer to the Bibliography.
---------------------- Page: 10 ----------------------
IEC 60601-2-35:2020 © IEC 2020 – 9 –
201.1.2 Object
Replacement:

The object of this particular standard is to establish 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 to specify tests for demonstrating compliance with these requirements.
201.1.3 Collateral standards
Addition:

This particular standard refers to those applicable collateral standards that are listed in

Clause 2 of the general standard and Clause 201.2 of this particular standard.
IEC 60601-1-2:2014, IEC 60601-1-8:2006 and IEC 60601-1-8:2006/AMD1:2012, and

IEC 60601-1-10:2007 and IEC 60601-1-10:2007/AMD1:2013 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
Replacement:

In the IEC 60601 series, particular standards may modify, replace or delete requirements

contained in the general standard and collateral standards as appropriate for the particular

ME EQUIPMENT under consideration, and may add other BASIC SAFETY and ESSENTIAL
PERFORMANCE requirements.
A requirement of a particular standard takes priority over the general standard.

For brevity, IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012 are referred to in this

particular standard as the general standard. Collateral standards are referred to by their

document number.

The numbering of clauses and subclauses of this document corresponds to that of the general

standard with the prefix "201" (e.g. 201.1 in this document addresses the content of Clause 1

of the general standard) or applicable collateral standard with the prefix "20x" where x is the

final digit(s) of the collateral standard document number (e.g. 202.4 in this document

addresses the content of Clause 4 of the IEC 60601-1-2 collateral standard, 203.4 in this

document addresses the content of Clause 4 of the IEC 60601-1-3 collateral standard, etc.).

The changes to the text of the general standard and applicable collateral standards are

specified by the use of the following words:

"Replacement" means that the clause or subclause of the general standard or applicable

collateral standard is replaced completely by the text of this particular standard.

"Addition" means that the text of this particular standard is additional to the requirements of

the general standard or applicable collateral standard.

"Amendment" means that the clause or subclause of the general standard or applicable

collateral standard is amended as indicated by the text of this particular standard.

---------------------- Page: 11 ----------------------
– 10 – IEC 60601-2-35:2020 © IEC 2020

Subclauses, figures or tables which are additional to those of the general standard are

numbered starting from 201.101. However due to the fact that definitions in the general

standard are numbered 3.1 through 3.147, additional definitions in this document are

numbered beginning from 201.3.201. Additional annexes are lettered AA, BB, etc., and

additional items aa), bb), etc.

Subclauses, figures or tables which are additional to those of a collateral standard are

numbered starting from 20x, where "x" is the number of the collateral standard, e.g. 202 for

IEC 60601-1-2, 203 for IEC 60601-1-3, etc.

The term "this document" is used to make reference to the general standard, any applicable

collateral standards and this particular standard taken together.

Where there is no corresponding clause or subclause in this particular standard, the clause or

subclause of the general standard or applicable collateral standard, although possibly not

relevant, applies without modification; where it is intended that any part of the general

standard or applicable collateral standard, although possibly relevant, is not to be applied, a

statement to that effect is given in this particular standard.
201.2 Normative references
NOTE Informative references are listed in the Bibliography.
Clause 2 of the general standard applies, except as follows:
Addition:

IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for basic

safety and essential performance
IEC 60601-1:2005/AMD1:2012

IEC 60601-1-10:2007, 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
Replacement:

IEC 60384-14:2013, Fixed capacitors for use in electronic equipment – Part 14: Sectional

specification – Fixed capacitors for electromagneticinterference suppression and connection

to the supply mains
IEC 60384-14:2013/AMD1:2016

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
201.3 Terms and definitions

For the purposes of this document, the terms and definitions specified in IEC 60601-1:2005

and IEC 60601-1:2005/AMD1:2012, and the following apply.
---------------------- Page: 12 ----------------------
IEC 60601-2-35:2020 © IEC 2020 – 11 –

ISO and IEC maintain terminological databases for use in standardization at the following

addresses:
• IEC Electropedia: available at http://www.electropedia.org/
• ISO Online browsing platform: available at http://www.iso.org/obp

NOTE An index of defined terms used in this document is found beginning on page 69.

Addition:
201.3.201.1
BLANKET

APPLIED PART of HEATING DEVICE, which can be folded, for

use under or over a PATIENT
201.3.201.2
BLANKET

APPLIED PART of HEATING DEVICE intended to be used with a CONTROLLER

PATIENT
to transfer thermal energy to all or part of the body of a
201.3.202
CONDITIONS OF ADEQUATE HEAT DISCHARGE

conditions achieved when a HEATING DEVICE is supported and covered as specified in

Annex EE
201.3.203.1
CONTACT SURFACE TEMPERATURE

temperature T at the reference point of the heated APPLIED

PART
Note 1 to entry: See Figures 201.101 and 201.102.

Note 2 to entry: The CONTACT SURFACE TEMPERATURE for FORCED AIR DEVICES is measured by the test methods

described in Annexes FF, GG and HH.
Key
T CONTACT SURFACE TEMPERATURE reference point on the contact surface
Some HEATING DEVICES may have unheated areas shown in the following figures as:
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)
---------------------- Page: 13 ----------------------
– 12 – IEC 60601-2-35:2020 © IEC 2020

The temperature at the centre point of any one of the heated areas closest to the centre of the HEATING DEVICE

(in the example shown above 2, 3, 6, or 7) is treated as T .
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
201.3.203.2
CONTACT SURFACE TEMPERATURE

< FORCED AIR DEVICES> temperature resulting from the heat transferred to a target surface by

the APPLIED PART
201.3.204
CONTROLLER

part of a HEATING DEVICE intended to supply and control thermal energy to a BLANKET, PAD or

MATTRESS
Note 1 to entry: This includes the HOSE, if present.
201.3.205
FORCED AIR DEVICE

HEATING DEVICE that uses air as the heat transfer medium to warm a PATIENT and is comprised

CONTROLLER and a BLANKET
of a
201.3.206
FREE HOSING
hazardous practice or condition of using the CONTROLLER without a BLANKET
201.3.207
HEATING DEVICE

ME EQUIPMENT intended to supply heat to the whole or part of the body of a PATIENT by means

of heated BLANKETS, PADS, or MATTRESSES
201.3.208
HIGH HEAT TRANSFER

thermal characteristic of a HEATING DEVICE as determined according to Annex CC or Annex DD

201.3.209
HOSE

component of the CONTROLLER that is the conduit for the heat transfer medium to and/or from

the BLANKET, PAD or MATTRESS
---------------------- Page: 14 ----------------------
IEC 60601-2-35:2020 © IEC 2020 – 13 –
201.3.210
INFANT
PATIENT up to the age of three months and with a weight less than 10 kg
201.3.211
LAGGING MATERIAL

polyurethane or polystyrene insulation material used in the test methods of this specification

to assist in the determination of temperature

Note 1 to entry: Specifications for LAGGING MATERIAL are given in Annexes BB and FF.

201.3.212
LOW HEAT TRANSFER

thermal characteristic of a HEATING DEVICE as determined according to Annex CC or Annex DD

201.3.213
MATTRESS

APPLIED PART of a HEATING DEVICE, which provides resilient support to the whole body of a

PATIENT
201.3.214
NOZZLE
end of the HOSE that connects to the BLANKET, PAD or MATTRESS
201.3.215
OVER-BLANKET
BLANKET designed to be used over a PATIENT
201.3.216
PAD
APPLIED PART of HEATING DEVICE, which can be bent but not folded
201.3.217
RUCK
unintended fold in a normally even surface
201.3.218
RUCK-RESISTANT BLANKET
BLANKET having a construction such that RUCKING of the flexible part is unlikely
201.3.219
UNDER-BLANKET
BLANKET designed to be used under a PATIENT
201.4 General requirements
Clause 4 of the general standard applies except as follows:
201.4.3 ESSENTIAL PERFORMANCE
Addition:
201.4.3.101 Additional requirements for ESSENTIAL PERFORMANCE

Additional ESSENTIAL PERFORMANCE requirements are found in the subclauses listed in

Table 201.101.
---------------------- Page: 15 ----------------------
– 14 – IEC 60601-2-35:2020 © IEC 2020
Table 201.101 – * Additional ESSENTIAL PERFORMANCE requirements
Requirement Subclause
ESSENTIAL PERFORMANCE requirement 1 201.12.4.104
...

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
IEC 60601-2-35:2020-09(en-fr)
---------------------- Page: 1 ----------------------
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---------------------- Page: 2 ----------------------
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

Warning! Make sure that you obtained this publication from an authorized distributor.

Attention! Veuillez vous assurer que vous avez obtenu cette publication via un distributeur agréé.

® Registered trademark of the International Electrotechnical Commission
Marque déposée de la Commission Electrotechnique Internationale
---------------------- Page: 3 ----------------------
– 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

---------------------- Page: 4 ----------------------
IEC 60601-2-35:2020 © IEC 2020 – 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 .......................................................................................................................... 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

---------------------- Page: 5 ----------------------
– 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

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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) 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.
---------------------- Page: 6 ----------------------
IEC 60601-2-35:2020 © IEC 2020 – 5 –
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 "inclusive or" so a statement is true if any

combination of the conditions is true.

The verbal forms used in this document conform to usage described in Clause 7 of the ISO/IEC

Directives, Part 2. For the purposes of this document, the auxiliary verb:

– "shall" means that compliance with a requirement or a test is mandatory for compliance with

this document;

– "should" means that compliance with a requirement or a test is recommended but is not

mandatory for compliance with this document;

– "may" is used to describe a permissible way to achieve compliance with a requirement or

test.

An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title

indicates that there is guidance or rationale related to that item in Annex AA.

A list of all parts of the 60601 International Standard, published under the general title Medical

electrical equipment, can be found on the IEC website.
---------------------- Page: 7 ----------------------
– 6 – IEC 60601-2-35:2020 © IEC 2020

The committee has decided that the contents of this document will remain unchanged until the

stability date indicated on the IEC website under "http://webstore.iec.ch" in the data related to

the specific document. At this date, the document will be
• reconfirmed,
• withdrawn,
• replaced by a revised edition, or
• amended.

NOTE The attention of users of this document is drawn to the fact that equipment manufacturers and testing

organizations may need a transitional period following publication of a new, amended or revised IEC 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 committees that the content of this publication be adopted for

implementation nationally not earlier than 3 years from the date of publication.

IMPORTANT – The "colour inside" logo on the cover page of this publication indicates

that it contains colours which are considered to be useful for the correct understanding

of its contents. Users should therefore print this publication using a colour printer.

---------------------- Page: 8 ----------------------
IEC 60601-2-35:2020 © IEC 2020 – 7 –
INTRODUCTION

The minimum safety requirements specified in this particular standard are considered to provide

for a practical degree of safety in the operation for HEATING DEVICES using BLANKETS, PADS or

MATTRESSES and intended for heating in medical use.

While K (degree Kelvin) is the recognized unit and symbol for absolute temperature and

temperature difference, °C has been used throughout this document because all measurements

are commonly made using equipment marked with the Celsius temperature scale.
---------------------- Page: 9 ----------------------
– 8 – IEC 60601-2-35:2020 © IEC 2020
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
201.1 Scope, object and related standards
Clause 1 of the general standard applies, except as follows:
201.1.1 * Scope
Replacement:

This part of 60601 International Standard 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.
NOTE See also 4.2 of the general standard.
This document does not apply to:
– HEATING DEVICES intended for physiotherapy;
– INFANT RADIANT WARMERS; for information, see IEC 60601-2-21 [1] ;
– INFANT INCUBATORS; for information, see IEC 60601-2-19 [2];
– INFANT TRANSPORT INCUBATORS, for information, see IEC 60601-2-20 [3];
– cooling devices.
_____________

The general standard is IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012, Medical electrical equipment –

Part 1: General requirements for basic safety and essential performance.
Figures in square brackets refer to the Bibliography.
---------------------- Page: 10 ----------------------
IEC 60601-2-35:2020 © IEC 2020 – 9 –
201.1.2 Object
Replacement:

The object of this particular standard is to establish 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 to

specify tests for demonstrating compliance with these requirements.
201.1.3 Collateral standards
Addition:

This particular standard refers to those applicable collateral standards that are listed in Clause

2 of the general standard and Clause 201.2 of this particular standard.
IEC 60601-1-2:2014, IEC 60601-1-8:2006 and IEC 60601-1-8:2006/AMD1:2012, and

IEC 60601-1-10:2007 and IEC 60601-1-10:2007/AMD1:2013 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
Replacement:

In the IEC 60601 series, particular standards may modify, replace or delete requirements

contained in the general standard and collateral standards as appropriate for the particular

ME EQUIPMENT under consideration, and may add other BASIC SAFETY and ESSENTIAL
PERFORMANCE requirements.
A requirement of a particular standard takes priority over the general standard.

For brevity, IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012 are referred to in this

particular standard as the general standard. Collateral standards are referred to by their

document number.

The numbering of clauses and subclauses of this document corresponds to that of the general

standard with the prefix "201" (e.g. 201.1 in this document addresses the content of Clause 1

of the general standard) or applicable collateral standard with the prefix "20x" where x is the

final digit(s) of the collateral standard document number (e.g. 202.4 in this document addresses

the content of Clause 4 of the IEC 60601-1-2 collateral standard, 203.4 in this document

addresses the content of Clause 4 of the IEC 60601-1-3 collateral standard, etc.). The changes

to the text of the general standard and applicable collateral standards are specified by the use

of the following words:

"Replacement" means that the clause or subclause of the general standard or applicable

collateral standard is replaced completely by the text of this particular standard.

"Addition" means that the text of this particular standard is additional to the requirements of the

general standard or applicable collateral standard.

"Amendment" means that the clause or subclause of the general standard or applicable

collateral standard is amended as indicated by the text of this particular standard.

---------------------- Page: 11 ----------------------
– 10 – IEC 60601-2-35:2020 © IEC 2020

Subclauses, figures or tables which are additional to those of the general standard are

numbered starting from 201.101. However due to the fact that definitions in the general standard

are numbered 3.1 through 3.147, additional definitions in this document are numbered

beginning from 201.3.201. Additional annexes are lettered AA, BB, etc., and additional items

aa), bb), etc.

Subclauses, figures or tables which are additional to those of a collateral standard are

numbered starting from 20x, where "x" is the number of the collateral standard, e.g. 202 for

IEC 60601-1-2, 203 for IEC 60601-1-3, etc.

The term "this document" is used to make reference to the general standard, any applicable

collateral standards and this particular standard taken together.

Where there is no corresponding clause or subclause in this particular standard, the clause or

subclause of the general standard or applicable collateral standard, although possibly not

relevant, applies without modification; where it is intended that any part of the general standard

or applicable collateral standard, although possibly relevant, is not to be applied, a statement

to that effect is given in this particular standard.
201.2 Normative references
NOTE Informative references are listed in the Bibliography.
Clause 2 of the general standard applies, except as follows:
Addition:

IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for basic safety

and essential performance
IEC 60601-1:2005/AMD1:2012

IEC 60601-1-10:2007, 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
Replacement:

IEC 60384-14:2013, Fixed capacitors for use in electronic equipment – Part 14: Sectional

specification – Fixed capacitors for electromagnetic interference suppression and connection

to the supply mains
IEC 60384-14:2013/AMD1:2016

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
201.3 Terms and definitions

For the purposes of this document, the terms and definitions specified in IEC 60601-1:2005 and

IEC 60601-1:2005/AMD1:2012, and the following apply.
---------------------- Page: 12 ----------------------
IEC 60601-2-35:2020 © IEC 2020 – 11 –

ISO and IEC maintain terminological databases for use in standardization at the following

addresses:
• IEC Electropedia: available at http://www.electropedia.org/
• ISO Online browsing platform: available at http://www.iso.org/obp

NOTE An index of defined terms used in this document is found beginning on page 69.

Addition:
201.3.201.1
BLANKET

APPLIED PART of HEATING DEVICE, which can be folded, for use

under or over a PATIENT
201.3.201.2
BLANKET

APPLIED PART of HEATING DEVICE intended to be used with a CONTROLLER

PATIENT
to transfer thermal energy to all or part of the body of a
201.3.202
CONDITIONS OF ADEQUATE HEAT DISCHARGE

conditions achieved when a HEATING DEVICE is supported and covered as specified in Annex EE

201.3.203.1
CONTACT SURFACE TEMPERATURE
FORCED AIR DEVICES> temperature T at the reference point of the heated APPLIED
PART
Note 1 to entry: See Figures 201.101 and 201.102.

Note 2 to entry: The CONTACT SURFACE TEMPERATURE for FORCED AIR DEVICES is measured by the test methods

described in Annexes FF, GG and HH.
Key
T CONTACT SURFACE TEMPERATURE reference point on the contact surface
Some HEATING DEVICES may have unheated areas shown in the following figures as:
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)
---------------------- Page: 13 ----------------------
– 12 – IEC 60601-2-35:2020 © IEC 2020
The temperature at the centre point of a
...

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