EN 80601-2-35:2009

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 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.

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

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: 10-Dec-2009
• Withdrawal Date: 31-Oct-2012
• ICS: 11.140 - Hospital equipment
• Technical Committee: CLC/TC 62 - Electrical equipment in medical practice
• Drafting Committee: IEC/SC 62D - IEC_SC_62D
• Parallel Committee: IEC/SC 62D - IEC_SC_62D
• Current Stage: 6060 - Document made available - Publishing
• Start Date: 11-Dec-2009
• Completion Date: 11-Dec-2009
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/295 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: SIST EN 80601-2-35:2010 - 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)

Relations

• Replaces: EN 60601-2-35:1996 - Medical electrical equipment - Part 2: Particular requirements for the safety of blankets, pads and mattresses, intended for heating in medical use
• Effective Date: 29-Jan-2023
• Replaced By: EN IEC 60601-2-35:2021 - 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
• Effective Date: 07-Jun-2022
• Amended By: EN 80601-2-35:2009/A11:2011 - 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
• Effective Date: 28-Jan-2023
• Amended By: EN 80601-2-35:2009/A1:2016 - 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
• Effective Date: 07-Jun-2022
• Corrected By: EN 80601-2-35:2009/AC:2015 - 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
• Effective Date: 07-Jun-2022

Standards Content (Sample)

SLOVENSKI STANDARD
01-februar-2010
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SIST EN 60601-2-35:1998
0HGLFLQVNDHOHNWULþQDRSUHPDGHO3RVHEQH]DKWHYH]DRVQRYQRYDUQRVWLQ
ELVWYHQH]DKWHYH]DUMXKHEOD]LQHLQSRVWHOMQHYORåNHQDPHQMHQH]DRJUHYDQMHSUL
PHGLFLQVNLXSRUDEL,(&
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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
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.

- 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).
__________
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
- 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.
__________
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
– 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
...