EN IEC 60601-2-35:2021
(Main)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
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)
Ta del mednarodnega standarda 60601 se uporablja za OSNOVNO VARNOST in BISTVENE LASTNOSTI za ODEJE, BLAZINE in POSTELJNE VLOŽKE, namenjene ogrevanju v medicinski uporabi, imenovane tudi ELEKTROMEDICINSKA OPREMA. NAPRAVE ZA OGREVANJE, namenjene predhodnemu ogrevanju postelje, so vključene v področje uporabe tega dokumenta.
Če je točka ali podtočka namenjena samo obravnavi ELEKTROMEDICINSKE OPREME ali ELEKTROMEDICINSKIH SISTEMOV, bo to zapisano v naslovu in vsebini točke ali podtočke. Če ni zapisano, točka ali podtočka obravnava ELEKTROMEDICINSKO OPREMO in ELEKTROMEDICINSKE SISTEME.
Če je točka ali podtočka namenjena samo obravnavi posebej opredeljene vrste ELEKTROMEDICINSKE OPREME, kot v primeru NAPRAVE Z UMETNIM PRETOKOM ZRAKA, bo to zapisano v naslovu in vsebini dane točke ali podtočke. Če ni zapisano, točka ali podtočka obravnava ELEKTROMEDICINSKO OPREMO in ELEKTROMEDICINSKE SISTEME.
Posebne zahteve tega dokumenta ne vključujejo temeljnih TVEGANJ pri predvideni fiziološki funkciji ELEKTROMEDICINSKE OPREME in SISTEMOV, ki spadajo na področje uporabe tega dokumenta, razen v poglavjih 7.2.13 in 8.4.1 splošnega standarda.
OPOMBA: Glej tudi točko 4.2 splošnega standarda.
Ta dokument se ne uporablja za:
– NAPRAVE ZA OGREVANJE za uporabo v fizioterapiji;
– OTROŠKE SEVALNE OGREVALNIKE; za informacije glej standard IEC 60601-2-21 [1]2;
– OTROŠKE INKUBATORJE; za informacije glej standard IEC 60601-2-19 [2];
– PRENOSNE OTROŠKE INKUBATORJE, za informacije glej standard IEC 60601-2-20 [3];
– naprave za hlajenje.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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
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)
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
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
– 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
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 .
...
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.
SIST EN IEC 80601-2-35:2021
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
SIST EN IEC 80601-2-35:2021
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)
SIST EN IEC 80601-2-35:2021
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
SIST EN IEC 80601-2-35:2021
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
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
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 .
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