Medical electrical equipment - Part 2-35: Particular requirements for basic safety and essential performance of blankets, pads and mattresses, intended for heating in medical use (IEC 80601-2-35:2009)

This 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 International Standard. 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 apply to a specifically defined type of ME EQUIPMENT, as is the case with FORCED AIR DEVICES, then the clause or subclause is entitled as such. Clauses or subclauses that apply to all types of ME EQUIPMENT within the scope of this standard are not specifically entitled. HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this standard are not covered by specific requirements in this standard except in 7.2.13 and 8.4.1 of the general standard.

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 80601-2-35:2009)

Appareils électromédicaux - Partie 2-35: Exigences particulières pour la sécurité de base et les performances essentielles des couvertures, coussins et matelas chauffants destinés au réchauffage des patients en usage médical (CEI 80601-2-35:2009)

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

Medicinska električna oprema - 2-35. del: Posebne zahteve za osnovno varnost in bistvene zahteve za rjuhe, blazine in posteljne vložke, namenjene za ogrevanje pri medicinski uporabi (IEC 80601-2-35:2009)

Ta mednarodni standard velja za OSNOVNO VARNOST in BISTVENO DELOVANJE NAPRAV ZA OGREVANJE, ki jih uporabljajo RJUHE, BLAZINE ali POSTELJNI VLOŽKI pri medicinski uporabi, prav tako imenovane kot ME OPREMA. GRELNE NAPRAVE, namenjene za predhodno gretje postelje, so vključene v področje uporabe tega mednarodnega standarda. Če je klavzula ali podklavzula izrecno namenjena samo za uporabo za ME OPREMO ali samo za ME SISTEME, bosta naslov in vsebina te klavzule ali podklavzule to tudi navedla. V nasprotnem primeru tako klavzula ali podklavzula veljata za ustrezno ME OPREMO in ME SISTEME. Če je klavzula ali podklavzula posebej namenjena temu, da velja za izrecno opredeljen tip ME OPREME, kot je v primeru NAPRAV Z VENTILATORJEM, potem je klavzula ali podklavzula ustrezno naslovljena. Klavzule ali podklavzule, ki veljajo za vse tipe ME OPREME znotraj področja uporabe tega standarda, niso posebej naslovljene. NEVARNOSTI, ki so del fiziološkega delovanja ME OPREME ali ME SISTEMOV znotraj področja uporabe tega standarda, niso zajete s posebnimi zahtevami tega standarda, razen v točkah 7.2.13 in 8.4.1 splošnega standarda.

General Information

Status
Published
Publication Date
17-Jan-2010
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
22-Dec-2009
Due Date
26-Feb-2010
Completion Date
18-Jan-2010

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SLOVENSKI STANDARD
SIST EN 80601-2-35:2010
01-februar-2010
1DGRPHãþD
SIST EN 60601-2-35:1998
0HGLFLQVNDHOHNWULþQDRSUHPDGHO3RVHEQH]DKWHYH]DRVQRYQRYDUQRVWLQ

ELVWYHQH]DKWHYH]DUMXKHEOD]LQHLQSRVWHOMQHYORåNHQDPHQMHQH]DRJUHYDQMHSUL

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Medical electrical equipment - Part 2-35: Particular requirements for basic safety and

essential performance of blankets, pads and mattresses, intended for heating in medical

use (IEC 80601-2-35:2009)

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 80601-2-35:2009)

Appareils électromédicaux - Partie 2-35: Exigences particulières pour la sécurité de base

et les performances essentielles des couvertures, coussins et matelas chauffants
destinés au réchauffage des patients en usage médical (CEI 80601-2-35:2009)
Ta slovenski standard je istoveten z: EN 80601-2-35:2009
ICS:
11.140 Oprema bolnišnic Hospital equipment
SIST EN 80601-2-35:2010 en,fr

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

---------------------- Page: 1 ----------------------
SIST EN 80601-2-35:2010
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SIST EN 80601-2-35:2010
EUROPEAN STANDARD
EN 80601-2-35
NORME EUROPÉENNE
December 2009
EUROPÄISCHE NORM
ICS 11.140 Supersedes EN 60601-2-35:1996
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 80601-2-35:2009)
Appareils électromédicaux - Medizinische elektrische Geräte -
Partie 2-35: Exigences particulières Teil 2-35: Besondere Festlegungen
pour la sécurité de base für die Sicherheit einschließlich
et les performances essentielles der wesentlichen Leistungsmerkmale
des dispositifs de réchauffage von Decken, Matten und Matratzen
utilisant des couvertures, des coussins zur Erwärmung von Patienten
ou des matelas chauffants in der medizinischen Anwendung
et destinés au réchauffage des patients (IEC 80601-2-35:2009)
en usage médical
(CEI 80601-2-35:2009)

This European Standard was approved by CENELEC on 2009-11-01. 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 Central Secretariat 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 Central Secretariat has the same status as the official versions.

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

Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,

Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain,

Sweden, Switzerland and the United Kingdom.
CENELEC
European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung
Central Secretariat: Avenue Marnix 17, B - 1000 Brussels

© 2009 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members.

Ref. No. EN 80601-2-35:2009 E
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SIST EN 80601-2-35:2010
EN 80601-2-35:2009 - 2 -
Foreword

The text of document 62D/784A/FDIS, future edition 2 of IEC 80601-2-35, prepared by SC 62D,

Electromedical equipment, of IEC TC 62, Electrical equipment in medical practice, and SC 1, Breathing

attachments and anaesthetic machines, of ISO TC 121: Anaesthetic and respiratory equipment, was

submitted to the IEC-CENELEC parallel vote and was approved by CENELEC as EN 80601-2-35 on

2009-11-01.
This European Standard supersedes EN 60601-2-35:1996.

This new edition provides consistency with EN 60601-1:2006, as well as with the four other particular

standards related to paediatric equipment for which the committee is responsible.

The following dates were fixed:
– latest date by which the EN has to be implemented
at national level by publication of an identical
(dop) 2010-08-01
national standard or by endorsement
– latest date by which the national standards conflicting
(dow) 2012-11-01
with the EN have to be withdrawn

This European Standard has been prepared under a mandate given to CENELEC by the European

Commission and the European Free Trade Association and covers essential requirements of

EC Directive MDD (93/42/EEC). See Annex ZZ.
In this standard, 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 standard, 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 standard are preceded by the term “Clause” followed by the clause

number. References to subclauses within this particular standard are by number only.

In this standard, 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 standard conform to usage described in Annex H of the ISO/IEC Directives,

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

− “shall” means that compliance with a requirement or a test is mandatory for compliance with this

standard;

− “should” means that compliance with a requirement or a test is recommended but is not mandatory for

compliance with this standard;

− “may” is used to describe a permissible way to achieve compliance with a requirement or test.

---------------------- Page: 4 ----------------------
SIST EN 80601-2-35:2010
- 3 - EN 80601-2-35:2009

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.
Annexes ZA and ZZ have been added by CENELEC.
__________
Endorsement notice

The text of the International Standard IEC 80601-2-35:2009 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:

[10] IEC 60601-2-19 NOTE Harmonized as EN 60601-2-19:2009 (not modified).
[11] IEC 60601-2-20 NOTE Harmonized as EN 60601-2-20:2009 (not modified).
[12] IEC 60601-2-21 NOTE Harmonized as EN 60601-2-21:2009 (not modified).
[19] IEC 60335-2-53 NOTE Harmonized as EN 60335-2-53:2003 (not modified).
__________
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SIST EN 80601-2-35:2010
EN 80601-2-35:2009 - 4 -
Annex ZA
(normative)
Normative references to international publications
with their corresponding European publications

The following referenced documents are indispensable for the application 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 When an international publication has been modified by common modifications, indicated by (mod), the relevant EN/HD

applies.
Publication Year Title EN/HD Year
Amendment:
IEC 60601-1-2 2007 Medical electrical equipment - EN 60601-1-2 2007
(mod) Part 1-2: General requirements for basic
safety and essential performance -
Collateral standard: Electromagnetic
compatibility - Requirements and tests
IEC 60601-1-8 2006 Medical electrical equipment - EN 60601-1-8 2007
Part 1-8: General requirements for basic
safety and essential performance -
Collateral Standard: General requirements,
tests and guidance for alarm systems in
medical electrical equipment and medical
electrical systems
ISO 14971 2007 Medical devices - Application of risk EN ISO 14971 2007
management to medical devices
Addition:
IEC 60601-1-10 2007 Medical electrical equipment - EN 60601-1-10 2008
Part 1-10: General requirements for basic
safety and essential performance -
Collateral Standard: Requirements for the
development of physiologic closed-loop
controllers
ISO 2439 2008 Flexible cellular polymeric materials - EN ISO 2439 2008
Determination of hardness (indentation
technique)
ISO 3743-1 1994 Acoustics - Determination of sound power EN ISO 3743-1 2009
levels of noise sources -
Engineering methods for small, movable
sources in reverberant fields -
Part 1: Comparison method for hard-walled
test rooms
---------------------- Page: 6 ----------------------
SIST EN 80601-2-35:2010
- 5 - EN 80601-2-35:2009
Annex ZZ
(informative)
Coverage of Essential Requirements of EC Directives

This European Standard has been prepared under a mandate given to CENELEC by the European

Commission and the European Free Trade Association and within its scope the standard covers all

relevant essential requirements as given in Annex I of the EC Directive 93/42/EEC.

Compliance with this standard provides one means of conformity with the specified essential

requirements of the Directive concerned.

WARNING: Other requirements and other EC Directives may be applicable to the products falling within

the scope of this standard.
__________
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SIST EN 80601-2-35:2010
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SIST EN 80601-2-35:2010
IEC 80601-2-35
Edition 2.0 2009-10
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
Medical electrical equipment –

Part 2-35: Particular requirements for the basic safety and essential performance

of heating devices using blankets, pads or mattresses and intended for heating
in medical use
Appareils électromédicaux –

Partie 2-35: Exigences particulières pour la sécurité de base et les performances

essentielles des dispositifs de réchauffage utilisant des couvertures, des
coussins ou des matelas chauffants et destinés au réchauffage des patients en
usage médical
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
PRICE CODE
INTERNATIONALE
CODE PRIX
ICS 11.140 ISBN 2-8318-1065-7
---------------------- Page: 9 ----------------------
SIST EN 80601-2-35:2010
– 2 – 80601-2-35 © IEC:2009
CONTENTS

FOREWORD...........................................................................................................................4

INTRODUCTION.....................................................................................................................7

201.1 Scope, object and related standards .......................................................................8

201.2 Normative references............................................................................................10

201.3 Terms and definitions............................................................................................10

201.4 General requirements ...........................................................................................13

201.5 General requirements for testing ME EQUIPMENT ....................................................14

201.6 Classification of ME EQUIPMENT and ME SYSTEMS....................................................14

201.7 ME EQUIPMENT identification, marking and documents ...........................................14

201.8 Protection against electrical HAZARDS from ME EQUIPMENT .....................................17

201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS ...........22

201.10 Protection against unwanted and excessive radiation HAZARDS .............................24

201.11 Protection against excessive temperatures and other HAZARDS .............................24

201.12 Accuracy of controls and instruments and protection against hazardous

outputs .................................................................................................................27

201.13 HAZARDOUS SITUATIONS and fault conditions ..........................................................32

201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) ............................................37

201.15 Construction of ME EQUIPMENT ...............................................................................37

201.16 ME SYSTEMS ..........................................................................................................41

201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS ...........................41

202 Electromagnetic compatibility – Requirements and tests .......................................42

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

ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS.......................................42

210 * Requirements for the development of physiologic closed-loop controllers ...........42

Annex D (informative) Symbols on marking..........................................................................43

Annex AA (informative) Particular guidance and rationale....................................................44

Annex BB (normative) Determination of the LAGGING MATERIAL .............................................55

Annex CC (normative) *Determination of heat transfer towards the PATIENT .........................56

Annex DD (normative) *Determination of heat transfer away from the PATIENT .....................58

Annex EE (normative) Conditions of adequate heat discharge .............................................59

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

for FORCED AIR DEVICES..........................................................................................................60

Annex GG (normative) Test procedure for maximum CONTACT SURFACE TEMPERATURE

for FORCED AIR DEVICES under SINGLE FAULT CONDITION...........................................................62

Annex HH (normative) Safety test procedure for average CONTACT SURFACE

TEMPERATURE for FORCED AIR DEVICES....................................................................................63

Bibliography..........................................................................................................................65

Index of defined terms used in this particular standard..........................................................66

Figure 201.101 – Positioning of temperature sensors on the contact surface of the

HEATING DEVICE (see 201.12.4.101 and 201.12.4.105).................................11

heated area of a

Figure 201.102 – Example of the positioning of temperature sensors on the contact

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

heated area ..........................................................................................................................11

---------------------- Page: 10 ----------------------
SIST EN 80601-2-35:2010
80601-2-35 © IEC:2009 – 3 –

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

(see 201.8.8.4.101)...............................................................................................................19

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

mask.....................................................................................................................................20

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

mask.....................................................................................................................................20

Figure 201.103 – Apparatus for the spark ignition test ..........................................................20

Figure 201.104 – Ramp for the impact test on PADS ..............................................................23

Figure 201.105 – Partial covering conditions.........................................................................25

Figure 201.106 – Method of folding BLANKETS .......................................................................34

Figure 201.107 – Examples of folds ......................................................................................36

Figure 201.108 – Positions of a BLANKET for the RUCK-RESISTANCE test..................................41

Figure HH.1 – Sensor locations – Average CONTACT SURFACE TEMPERATURE..........................64

Table 201.101 – *Additional ESSENTIAL PERFORMANCE requirements ......................................13

Table 201.102 – Temperature limits in dependency to time...................................................38

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SIST EN 80601-2-35:2010
– 4 – 80601-2-35 © IEC:2009
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL ELECTRICAL EQUIPMENT –
Part 2-35: Particular requirements for the basic safety
and essential performance of heating devices using blankets,
pads or mattresses and intended for heating in medical use
FOREWORD

1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising

all national electrotechnical committees (IEC National Committees). The object of IEC is to promote

international co-operation on all questions concerning standardization in the electrical and electronic fields. To

this end and in addition to other activities, IEC publishes International Standards, Technical Specifications,

Technical Reports, Publicly Available Specifications (PAS) and Guides (hereafter referred to as “IEC

Publication(s)”). Their preparation is entrusted to technical committees; any IEC National Committee interested

in the subject dealt with may participate in this preparatory work. International, governmental and non-

governmental organizations liaising with the IEC also participate in this preparation. IEC collaborates closely

with the International Organization for Standardization (ISO) in accordance with conditions determined by

agreement between the two organizations.

2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international

consensus of opinion on the relevant subjects since each technical committee has representation from all

interested IEC National Committees.

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

Committees in that sense. While all reasonable efforts are made to ensure that the technical content of IEC

Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any

misinterpretation by any end user.

4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications

transparently to the maximum extent possible in their national and regional publications. Any divergence

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

the latter.

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

assessment services and, in some areas, access to IEC 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 80601-2-35 has been prepared by IEC technical committee 62D:

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

practice, and subcommittee 1: Breathing attachments and anaesthetic machines, of ISO

technical committee 121: Anaesthetic and respiratory equipment.

This second edition cancels and replaces the first edition published in 1996. This edition

constitutes a technical revision.

This new edition provides consistency with the third edition of IEC 60601-1, as well as with

the four other particular standards related to paediatric equipment for which the committee is

responsible.
---------------------- Page: 12 ----------------------
SIST EN 80601-2-35:2010
80601-2-35 © IEC:2009 – 5 –
The text of this particular standard is based on the following documents:
FDIS Report on voting
62D/784A/FDIS 62D/804/RVD

Full information on the voting for the approval of this particular standard can be found in the

report on voting indicated in the above table. In ISO, the standard has been approved by

15 P-members out of 15 having cast a vote.

This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.

In this standard, 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 standard, 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 standard are preceded by the term “Clause” followed by the

clause number. References to subclauses within this particular standard are by number only.

In this standard, 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 standard conform to usage described in Annex H of the ISO/IEC

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

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

with this standard;

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

mandatory for compliance with this standard;

– “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 IEC 60601 series, published under the general title: Medical electrical

equipment can be found on the IEC website.
---------------------- Page: 13 ----------------------
SIST EN 80601-2-35:2010
– 6 – 80601-2-35 © IEC:2009

The committee has decided that the contents of this particular standard will remain

unchanged until the maintenance result date indicated on the IEC web site under

"http://webstore.iec.ch" in the data related to the specific publication. At this date, the

publication will be
• reconfirmed;
• withdrawn;
• replaced by a revised edition, or
• amended.

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: 14 ----------------------
SIST EN 80601-2-35:2010
80601-2-35 © IEC:2009 – 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.

This particular standard amends and supplements IEC 60601-1 (third edition, 2005) Medical

electrical equipment – Part 1: General requirements for basic safety and essential

performance, hereinafter referred to as the general standard. The text of this particular

standard relating to forced air warmers is based on ASTM F2196-02, Standard specification

for circulating liquid and forced air patient temperature management devices.
The requirements are followed by specifications for the relevant tests.

A "general guidance and rationale" section giving some explanatory notes, where appropriate,

about the more important requirements is included in Annex AA.

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

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

measurements are commonly made using equipment marked with the Celsius temperature

scale.
---------------------- Page: 15 ----------------------
SIST EN 80601-2-35:2010
– 8 – 80601-2-35 © IEC:2009
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:
BASIC SAFETY and ESSENTIAL PERFORMANCE of
This International Standard applies to the

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

International Standard.

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 apply to a specifically defined type of ME

EQUIPMENT, as is the case with FORCED AIR DEVICES, then the clause or subclause is entitled as

such. Clauses or subclauses that apply to all types of ME EQUIPMENT within the scope of this

standard are not specifically entitled.

HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS

within the scope of this standard are not covered by specific requirements in this standard

except in 7.2.13 and 8.4.1 of the general standard.
NOTE See also 4.2 of the general standard.
This particular standard does not apply to:
– HEATING DEVICES intended for physiotherapy;
– radiant warmers; for information, see IEC 60601-2-21 [12] ;
– incubators; for information, see IEC 60601-2-19 [10];
– transport incubators, for information, see IEC 60601-2-20 [11];
– cooling devices.
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

—————————

The general standard is IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for

basic safety and essential performance.
Figures in square brackets refer to the Bibliography.
---------------------- Page: 16 ----------------------
SIST EN 80601-2-35:2010
80601-2-35 © IEC:2009 – 9 –

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, IEC 60601-1-8 and IEC 60601-1-10 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
...

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