IEC 80601-2-35:2009
(Main)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
Medical electrical equipment — Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads or mattresses and intended for heating in medical use
IEC 80601-2-35:2009 establishes 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 specifies tests for demonstrating compliance with these requirements. 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.
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
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.
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Standards Content (Sample)
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
IEC 80601-2-35:2009
---------------------- Page: 1 ----------------------
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---------------------- Page: 2 ----------------------
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
XB
CODE PRIX
ICS 11.140 ISBN 2-8318-1065-7
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– 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
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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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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
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9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of
patent rights. IEC shall not be held responsible for identifying any or all such patent rights.
International Standard IEC 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.
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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.
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– 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.
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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.
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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
1)
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;
2
– 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
—————————
1)
The general standard is IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for
basic safety and essential performance.
2)
Figures in square brackets refer to the Bibliography.
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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, 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 is 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 particular standard corresponds to that of
the general standard with the prefix “201” (e.g. 201.1 in this standard 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
particular standard addresses the content of Clause 4 of the 60601-1-2 collateral standard,
203.4 in this particular standard addresses the content of Clause 4 of the 60601-1-3 collateral
standard, etc.). The changes to the text of the general standard 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.
Subclauses or figures 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 3.139, additional definitions in this standard are numbered beginning
from 201.3.201. Additional annexes are lettered AA, BB, etc., and additional items aa), bb),
etc.
Subclauses or figures 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 standard" is used to make reference to the general standard, any applicable
collateral standards and this particular standard taken together.
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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:
Amendment:
IEC 60601-1-2:2007, Medical electrical equipment – 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 – 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 management to medical devices
Addition:
IEC 60601-1-10:2007, Medical electrical equipment – Part 1-10: General requirements for
basic safety and essential performance – Collateral Standard: Requirements for the
development of physiologic closed-loop controllers
ISO 2439:2008, Flexible cellular polymeric materials – Determination of hardness (indentation
technique)
ISO 3743-1:1994, Acoustics – Determination of sound power levels of noise sources –
Engineering methods for small, movable sources in reverberant fields – Part 1: Comparison
method for hard-walled test rooms
201.3 Terms and definitions
NOTE An index of defined terms used in this document is found beginning on page 66.
For the purposes of this document, the terms and definitions given in IEC 60601-1:2005,
apply, except as follows:
Addition:
201.3.201
BLANKET
for FORCED AIR DEVICES, APPLIED PART of HEATING DEVICE intended to be used with a
CONTROLLER to transfer thermal energy to all or part of the body of a PATIENT; for other than
FORCED AIR DEVICES, APPLIED PART of HEATING DEVICE, which can be folded, for use under or
over a PATIENT
201.3.202
CONDITIONS OF ADEQUATE HEAT DISCHARGE
conditions achieved when a HEATING DEVICE is supported and covered as specified in
Annex EE
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80601-2-35 © IEC:2009 – 11 –
201.3.203
CONTACT SURFACE TEMPERATURE
for FORCED AIR DEVICES, temperature resulting from the heat transferred to a target surface by
the APPLIED PART; for other than FORCED AIR DEVICES temperature T at the reference point of
R
the heated APPLIED PART (see Figures 201.101 and 201.102)
NOTE The CONTACT SURFACE TEMPERATURE for FORCED AIR DEVICES is measured by the test methods described in
Annexes FF, GG and HH.
T
2
T
3
T
R
T
1
T
4
IEC 1992/09
Key
T CONTACT SURFACE TEMPERATURE reference point on the contact surface
R
Some heating devices may have unheated areas shown in the following figures as:
Figure 201.101 – Positioning of temperature sensors on the contact surface
of the heated area of a HEATING DEVICE
(see 201.12.4.101 and 201.12.4.105)
4
3
5
2
...
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