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.

Medizinische elektrische Geräte - Teil 2-35: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Decken, Matten und Matratzen zur Erwärmung von Patienten in der medizinischen Anwendung

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

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).

Medicinska električna oprema - 2-35. del: Posebne zahteve za osnovno varnost in bistvene lastnosti za odeje, blazine in posteljne vložke, namenjene za ogrevanje pri medicinski uporabi (IEC 60601-2-35:2020)

General Information

Status
Published
Publication Date
15-Jul-2021
Current Stage
6060 - Document made available - Publishing
Start Date
16-Jul-2021
Completion Date
16-Jul-2021

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SLOVENSKI STANDARD
SIST EN IEC 60601-2-35:2021
01-september-2021
Nadomešča:
SIST EN 80601-2-35:2010
SIST EN 80601-2-35:2010/A1:2017
SIST EN 80601-2-35:2010/A11:2012
SIST EN 80601-2-35:2010/AC:2015
Medicinska električna oprema - 2-35. del: Posebne zahteve za osnovno varnost in
bistvene lastnosti za odeje, blazine in posteljne vložke, namenjene za ogrevanje
pri medicinski uporabi (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 (IEC 60601-2-35:2020)

Medizinische elektrische Geräte - Teil 2-35: Besondere Festlegungen für die Sicherheit

einschließlich der wesentlichen Leistungsmerkmale von Decken, Matten und Matratzen

zur Erwärmung von Patienten in der medizinischen Anwendung (IEC 60601-2-35:2020)

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 60601-2-35:2020)
Ta slovenski standard je istoveten z: EN IEC 60601-2-35:2021
ICS:
11.140 Oprema bolnišnic Hospital equipment
SIST EN IEC 60601-2-35:2021 en

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN IEC 60601-2-35:2021
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SIST EN IEC 60601-2-35:2021
EUROPEAN STANDARD EN IEC 60601-2-35
NORME EUROPÉENNE
EUROPÄISCHE NORM
July 2021
ICS 11.140; 11.040.01 Supersedes EN 80601-2-35:2009 and all of its
amendments and corrigenda (if any)
English Version
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)

Appareils électromédicaux - Partie 2-35: Exigences Medizinische elektrische Geräte - Teil 2-35: Besondere

particulières pour la sécurité de base et les performances Festlegungen für die Sicherheit einschließlich der

essentielles des dispositifs de réchauffage utilisant des wesentlichen Leistungsmerkmale von Decken, Matten und

couvertures, des coussins ou des matelas chauffants et Matratzen zur Erwärmung von Patienten in der

destinés au réchauffage des patients en usage médical medizinischen Anwendung
(IEC 60601-2-35:2020) (IEC 60601-2-35:2020)

This European Standard was approved by CENELEC on 2020-10-26. CENELEC members are bound to comply with the CEN/CENELEC

Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration.

Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC

Management Centre or to any CENELEC member.

This European Standard exists in three official versions (English, French, German). A version in any other language made by translation

under the responsibility of a CENELEC member into its own language and notified to the CEN-CENELEC Management Centre has the

same status as the official versions.

CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus, the Czech Republic,

Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the

Netherlands, Norway, Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,

Turkey and the United Kingdom.
European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels

© 2021 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.

Ref. No. EN IEC 60601-2-35:2021 E
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SIST EN IEC 60601-2-35:2021
EN IEC 60601-2-35:2021 (E)
European foreword

The text of document 62D/1765/FDIS, future edition 2 of IEC 60601-2-35, prepared by SC 62D

"Electromedical equipment" of IEC/TC 62 "Electrical equipment in medical practice" was submitted to

the IEC-CENELEC parallel vote and approved by CENELEC as EN IEC 60601-2-35:2021.
The following dates are fixed:

• latest date by which the document has to be implemented at national (dop) 2022-01-16

level by publication of an identical national
standard or by endorsement

• latest date by which the national standards conflicting with the (dow) 2024-07-16

document have to be withdrawn

This document supersedes EN 80601-2-35:2009 and all of its amendments and corrigenda (if any).

Attention is drawn to the possibility that some of the elements of this document may be the subject of

patent rights. CENELEC shall not be held responsible for identifying any or all such patent rights.

Any feedback and questions on this document should be directed to the users’ national committee. A

complete listing of these bodies can be found on the CENELEC website.
Endorsement notice

The text of the International Standard IEC 60601-2-35:2020 was approved by CENELEC as a

European Standard without any modification.

In the official version, for Bibliography, the following notes have to be added for the standards

indicated:
IEC 60601-2-19:2020 NOTE Harmonized as EN IEC 60601-2-19:2021 (not modified)
IEC 60601-2-20:2020 NOTE Harmonized as EN IEC 60601-2-20:2020 (not modified)
IEC 60601-2-21:2020 NOTE Harmonized as EN IEC 60601-2-21:2020 (not modified)
IEC 60335-2-53 NOTE Harmonized as EN 60335-2-53
IEC 60529:1989 NOTE Harmonized as EN 60529:1991 (not modified)
IEC 60529:1989/A1:1999 NOTE Harmonized as EN 60529:1991/A1:2000 (not modified)
IEC 60529:1989/A2:2013 NOTE Harmonized as EN 60529:1991/A2:2013 (not modified)
ISO 2439:2008 NOTE Harmonized as EN ISO 2439:2008 (not modified)
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SIST EN IEC 60601-2-35:2021
EN IEC 60601-2-35:2021 (E)
Annex ZA
(normative)
Normative references to international publications
with their corresponding European publications

The following documents are referred to in the text in such a way that some or all of their content

constitutes requirements of this document. For dated references, only the edition cited applies. For

undated references, the latest edition of the referenced document (including any amendments)

applies.

NOTE 1 Where an International Publication has been modified by common modifications, indicated by (mod),

the relevant EN/HD applies.

NOTE 2 Up-to-date information on the latest versions of the European Standards listed in this annex is

available here: www.cenelec.eu.
The Annex ZA of EN 60601-1:2006/A1:2013 applies with the following additions:
Publication Year Title EN/HD Year
IEC 60601-1 2005 Medical electrical equipment - Part 1: EN 60601-1 2006
General requirements for basic safety and
essential performance
- - + corrigendum Mar. 2010
+ A1 2012 + A1 2013
- - + A12 2014
IEC 60601-1-10 2007 Medical electrical equipment - Part 1-10: EN 60601-1-10 2008
General requirements for basic safety and
essential performance - Collateral
Standard: Requirements for the
development of physiologic closed-loop
controllers
+ A1 2013 + A1 2015
The Annex ZA of EN 60601-1:2006/A1:2013 applies with the following replacements:
IEC 60384-14 2013 Fixed capacitors for use in electronic EN 60384-14 2013
equipment - Part 14: Sectional
specification - Fixed capacitors for
electromagnetic interference suppression
and connection to the supply mains
+ A1 2016 + A1 2016
IEC 60601-1-2 2014 Medical electrical equipment - Part 1-2: EN 60601-1-2 2015
General requirements for basic safety and
essential performance - Collateral
Standard: Electromagnetic disturbances -
Requirements and tests
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SIST EN IEC 60601-2-35:2021
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SIST EN IEC 60601-2-35:2021
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: 7 ----------------------
SIST EN IEC 60601-2-35:2021
– 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

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SIST EN IEC 60601-2-35:2021
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

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SIST EN IEC 60601-2-35:2021
– 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.

5) IEC itself does not provide any attestation of conformity. Independent certification bodies provide conformity

assessment services and, in some areas, access to IEC marks of conformity. IEC is not responsible for any

services carried out by independent certification bodies.

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

7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and

members of its technical committees and IEC National Committees for any personal injury, property damage or

other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and

expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC

Publications.

8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is

indispensable for the correct application of this publication.

9) 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.
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SIST EN IEC 60601-2-35:2021
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.
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SIST EN IEC 60601-2-35:2021
– 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.

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SIST EN IEC 60601-2-35:2021
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.
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SIST EN IEC 60601-2-35:2021
– 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.
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SIST EN IEC 60601-2-35:2021
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.

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SIST EN IEC 60601-2-35:2021
– 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:
Additio
...

SLOVENSKI STANDARD
SIST EN IEC 80601-2-35:2021
01-september-2021
Nadomešča:
SIST EN 80601-2-35:2010
SIST EN 80601-2-35:2010/A1:2017
SIST EN 80601-2-35:2010/A11:2012
SIST EN 80601-2-35:2010/AC:2015
Medicinska električna oprema - 2-35. del: Posebne zahteve za osnovno varnost in
bistvene lastnosti za odeje, blazine in posteljne vložke, namenjene za ogrevanje
pri medicinski uporabi (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 (IEC 60601-2-35:2020)

Medizinische elektrische Geräte - Teil 2-35: Besondere Festlegungen für die Sicherheit

einschließlich der wesentlichen Leistungsmerkmale von Decken, Matten und Matratzen

zur Erwärmung von Patienten in der medizinischen Anwendung (IEC 60601-2-35:2020)

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 60601-2-35:2020)
Ta slovenski standard je istoveten z: EN IEC 60601-2-35:2021
ICS:
11.140 Oprema bolnišnic Hospital equipment
SIST EN IEC 80601-2-35:2021 en

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN IEC 80601-2-35:2021
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SIST EN IEC 80601-2-35:2021
EUROPEAN STANDARD EN IEC 60601-2-35
NORME EUROPÉENNE
EUROPÄISCHE NORM
July 2021
ICS 11.140; 11.040.01 Supersedes EN 80601-2-35:2009 and all of its
amendments and corrigenda (if any)
English Version
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)

Appareils électromédicaux - Partie 2-35: Exigences Medizinische elektrische Geräte - Teil 2-35: Besondere

particulières pour la sécurité de base et les performances Festlegungen für die Sicherheit einschließlich der

essentielles des dispositifs de réchauffage utilisant des wesentlichen Leistungsmerkmale von Decken, Matten und

couvertures, des coussins ou des matelas chauffants et Matratzen zur Erwärmung von Patienten in der

destinés au réchauffage des patients en usage médical medizinischen Anwendung
(IEC 60601-2-35:2020) (IEC 60601-2-35:2020)

This European Standard was approved by CENELEC on 2020-10-26. CENELEC members are bound to comply with the CEN/CENELEC

Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration.

Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC

Management Centre or to any CENELEC member.

This European Standard exists in three official versions (English, French, German). A version in any other language made by translation

under the responsibility of a CENELEC member into its own language and notified to the CEN-CENELEC Management Centre has the

same status as the official versions.

CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus, the Czech Republic,

Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the

Netherlands, Norway, Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,

Turkey and the United Kingdom.
European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels

© 2021 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.

Ref. No. EN IEC 60601-2-35:2021 E
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SIST EN IEC 80601-2-35:2021
EN IEC 60601-2-35:2021 (E)
European foreword

The text of document 62D/1765/FDIS, future edition 2 of IEC 60601-2-35, prepared by SC 62D

"Electromedical equipment" of IEC/TC 62 "Electrical equipment in medical practice" was submitted to

the IEC-CENELEC parallel vote and approved by CENELEC as EN IEC 60601-2-35:2021.
The following dates are fixed:

• latest date by which the document has to be implemented at national (dop) 2022-01-16

level by publication of an identical national
standard or by endorsement

• latest date by which the national standards conflicting with the (dow) 2024-07-16

document have to be withdrawn

This document supersedes EN 80601-2-35:2009 and all of its amendments and corrigenda (if any).

Attention is drawn to the possibility that some of the elements of this document may be the subject of

patent rights. CENELEC shall not be held responsible for identifying any or all such patent rights.

Any feedback and questions on this document should be directed to the users’ national committee. A

complete listing of these bodies can be found on the CENELEC website.
Endorsement notice

The text of the International Standard IEC 60601-2-35:2020 was approved by CENELEC as a

European Standard without any modification.

In the official version, for Bibliography, the following notes have to be added for the standards

indicated:
IEC 60601-2-19:2020 NOTE Harmonized as EN IEC 60601-2-19:2021 (not modified)
IEC 60601-2-20:2020 NOTE Harmonized as EN IEC 60601-2-20:2020 (not modified)
IEC 60601-2-21:2020 NOTE Harmonized as EN IEC 60601-2-21:2020 (not modified)
IEC 60335-2-53 NOTE Harmonized as EN 60335-2-53
IEC 60529:1989 NOTE Harmonized as EN 60529:1991 (not modified)
IEC 60529:1989/A1:1999 NOTE Harmonized as EN 60529:1991/A1:2000 (not modified)
IEC 60529:1989/A2:2013 NOTE Harmonized as EN 60529:1991/A2:2013 (not modified)
ISO 2439:2008 NOTE Harmonized as EN ISO 2439:2008 (not modified)
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SIST EN IEC 80601-2-35:2021
EN IEC 60601-2-35:2021 (E)
Annex ZA
(normative)
Normative references to international publications
with their corresponding European publications

The following documents are referred to in the text in such a way that some or all of their content

constitutes requirements of this document. For dated references, only the edition cited applies. For

undated references, the latest edition of the referenced document (including any amendments)

applies.

NOTE 1 Where an International Publication has been modified by common modifications, indicated by (mod),

the relevant EN/HD applies.

NOTE 2 Up-to-date information on the latest versions of the European Standards listed in this annex is

available here: www.cenelec.eu.
The Annex ZA of EN 60601-1:2006/A1:2013 applies with the following additions:
Publication Year Title EN/HD Year
IEC 60601-1 2005 Medical electrical equipment - Part 1: EN 60601-1 2006
General requirements for basic safety and
essential performance
- - + corrigendum Mar. 2010
+ A1 2012 + A1 2013
- - + A12 2014
IEC 60601-1-10 2007 Medical electrical equipment - Part 1-10: EN 60601-1-10 2008
General requirements for basic safety and
essential performance - Collateral
Standard: Requirements for the
development of physiologic closed-loop
controllers
+ A1 2013 + A1 2015
The Annex ZA of EN 60601-1:2006/A1:2013 applies with the following replacements:
IEC 60384-14 2013 Fixed capacitors for use in electronic EN 60384-14 2013
equipment - Part 14: Sectional
specification - Fixed capacitors for
electromagnetic interference suppression
and connection to the supply mains
+ A1 2016 + A1 2016
IEC 60601-1-2 2014 Medical electrical equipment - Part 1-2: EN 60601-1-2 2015
General requirements for basic safety and
essential performance - Collateral
Standard: Electromagnetic disturbances -
Requirements and tests
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SIST EN IEC 80601-2-35:2021
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: 7 ----------------------
SIST EN IEC 80601-2-35:2021
– 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

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SIST EN IEC 80601-2-35:2021
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

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SIST EN IEC 80601-2-35:2021
– 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.

5) IEC itself does not provide any attestation of conformity. Independent certification bodies provide conformity

assessment services and, in some areas, access to IEC marks of conformity. IEC is not responsible for any

services carried out by independent certification bodies.

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

7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and

members of its technical committees and IEC National Committees for any personal injury, property damage or

other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and

expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC

Publications.

8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is

indispensable for the correct application of this publication.

9) 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.
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SIST EN IEC 80601-2-35:2021
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.
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SIST EN IEC 80601-2-35:2021
– 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.

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SIST EN IEC 80601-2-35:2021
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.
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SIST EN IEC 80601-2-35:2021
– 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.
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SIST EN IEC 80601-2-35:2021
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.

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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:
Additio
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