SIST 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 (IEC 60601-2-35:2020)

This part of 60601 International Standard applies to the BASIC SAFETY and ESSENTIAL
PERFORMANCE of HEATING DEVICES using BLANKETS, PADS or MATTRESSES in medical use, also
referred to as ME EQUIPMENT. HEATING DEVICES intended to prewarm a bed are included in the
scope of this document.
If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to
ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the
case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant.
If a clause or subclause is specifically intended to be applicable to a specifically defined type
of ME EQUIPMENT, as is the case with FORCED AIR DEVICES, then the title and content of that
clause or subclause will say so. If that is not the case, the clause or subclause applies both to
ME EQUIPMENT and to ME SYSTEMS, as relevant.
HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS
within the scope of this document are not covered by specific requirements in this document,
except in 7.2.13 and 8.4.1 of the general standard.
NOTE See also 4.2 of the general standard.
This document does not apply to:
– HEATING DEVICES intended for physiotherapy;
– INFANT RADIANT WARMERS; for information, see IEC 60601-2-21 [1]2;
– INFANT INCUBATORS; for information, see IEC 60601-2-19 [2];
– INFANT TRANSPORT INCUBATORS, for information, see IEC 60601-2-20 [3];
– cooling devices.

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)

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

• Status: Published
• Publication Date: 22-Aug-2021
• ICS: 11.140 - Hospital equipment
• Technical Committee: IEMO - Electrical equipment in medical practice
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 27-Jul-2021
• Due Date: 01-Oct-2021
• Completion Date: 23-Aug-2021
• 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: 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

Relations

• Replaces: 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)
• Effective Date: 07-Jun-2022
• Replaces: SIST EN 80601-2-35:2010/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: 20-Jul-2021
• Replaces: 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)
• Effective Date: 20-Jul-2021
• Replaces: SIST EN 80601-2-35:2010/A11:2012 - 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: 20-Jul-2021
• Replaces: SIST EN 80601-2-35:2010/A1:2017 - 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/A1:2016)
• Effective Date: 20-Jul-2021
• Amended By: SIST EN IEC 60601-2-35:2021/A1:2024 - 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/AMD1:2023)
• Effective Date: 26-Jul-2021
• Revised: 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)
• Effective Date: 20-Nov-2018

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN IEC 60601-2-35:2021
01-september-2021
Nadomešča:
SIST EN 80601-2-35:2010
SIST EN 80601-2-35:2010/A1:2017
SIST EN 80601-2-35:2010/A11:2012
SIST EN 80601-2-35:2010/AC:2015
Medicinska električna oprema - 2-35. del: Posebne zahteve za osnovno varnost in
bistvene lastnosti za odeje, blazine in posteljne vložke, namenjene za ogrevanje
pri medicinski uporabi (IEC 60601-2-35:2020)
Medical electrical equipment - Part 2-35: Particular requirements for the basic safety and
essential performance of heating devices using blankets, pads and mattresses and
intended for heating in medical use (IEC 60601-2-35:2020)
Medizinische elektrische Geräte - Teil 2-35: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von Decken, Matten und Matratzen
zur Erwärmung von Patienten in der medizinischen Anwendung (IEC 60601-2-35:2020)
Appareils électromédicaux - Partie 2-35: Exigences particulières pour la sécurité de base
et les performances essentielles des dispositifs de réchauffage utilisant des couvertures,
des coussins ou des matelas chauffants et destinés au réchauffage des patients en
usage médical (IEC 60601-2-35:2020)
Ta slovenski standard je istoveten z: EN IEC 60601-2-35:2021
ICS:
11.140 Oprema bolnišnic Hospital equipment
SIST EN IEC 60601-2-35:2021 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN IEC 60601-2-35:2021

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SIST EN IEC 60601-2-35:2021


EUROPEAN STANDARD EN IEC 60601-2-35

NORME EUROPÉENNE

EUROPÄISCHE NORM
July 2021
ICS 11.140; 11.040.01 Supersedes EN 80601-2-35:2009 and all of its
amendments and corrigenda (if any)
English Version
Medical electrical equipment - Part 2-35: Particular requirements
for the basic safety and essential performance of heating
devices using blankets, pads and mattresses and intended for
heating in medical use
(IEC 60601-2-35:2020)
Appareils électromédicaux - Partie 2-35: Exigences Medizinische elektrische Geräte - Teil 2-35: Besondere
particulières pour la sécurité de base et les performances Festlegungen für die Sicherheit einschließlich der
essentielles des dispositifs de réchauffage utilisant des wesentlichen Leistungsmerkmale von Decken, Matten und
couvertures, des coussins ou des matelas chauffants et Matratzen zur Erwärmung von Patienten in der
destinés au réchauffage des patients en usage médical medizinischen Anwendung
(IEC 60601-2-35:2020) (IEC 60601-2-35:2020)
This European Standard was approved by CENELEC on 2020-10-26. CENELEC members are bound to comply with the CEN/CENELEC
Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration.
Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC
Management Centre or to any CENELEC member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by translation
under the responsibility of a CENELEC member into its own language and notified to the CEN-CENELEC Management Centre has the
same status as the official versions.
CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus, the Czech Republic,
Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the
Netherlands, Norway, Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.


European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2021 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
 Ref. No. EN IEC 60601-2-35:2021 E

---------------------- Page: 3 ----------------------
SIST EN IEC 60601-2-35:2021
EN IEC 60601-2-35:2021 (E)
European foreword
The text of document 62D/1765/FDIS, future edition 2 of IEC 60601-2-35, prepared by SC 62D
"Electromedical equipment" of IEC/TC 62 "Electrical equipment in medical practice" was submitted to
the IEC-CENELEC parallel vote and approved by CENELEC as EN IEC 60601-2-35:2021.
The following dates are fixed:
• latest date by which the document has to be implemented at national (dop) 2022-01-16
level by publication of an identical national
standard or by endorsement
• latest date by which the national standards conflicting with the (dow) 2024-07-16
document have to be withdrawn
This document supersedes EN 80601-2-35:2009 and all of its amendments and corrigenda (if an
...

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.

---------------------- Page: 1 ----------------------
SIST EN IEC 80601-2-35:2021

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SIST EN IEC 80601-2-35:2021


EUROPEAN STANDARD EN IEC 60601-2-35

NORME EUROPÉENNE

EUROPÄISCHE NORM
July 2021
ICS 11.140; 11.040.01 Supersedes EN 80601-2-35:2009 and all of its
amendments and corrigenda (if any)
English Version
Medical electrical equipment - Part 2-35: Particular requirements
for the basic safety and essential performance of heating
devices using blankets, pads and mattresses and intended for
heating in medical use
(IEC 60601-2-35:2020)
Appareils électromédicaux - Partie 2-35: Exigences Medizinische elektrische Geräte - Teil 2-35: Besondere
particulières pour la sécurité de base et les performances Festlegungen für die Sicherheit einschließlich der
essentielles des dispositifs de réchauffage utilisant des wesentlichen Leistungsmerkmale von Decken, Matten und
couvertures, des coussins ou des matelas chauffants et Matratzen zur Erwärmung von Patienten in der
destinés au réchauffage des patients en usage médical medizinischen Anwendung
(IEC 60601-2-35:2020) (IEC 60601-2-35:2020)
This European Standard was approved by CENELEC on 2020-10-26. CENELEC members are bound to comply with the CEN/CENELEC
Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration.
Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC
Management Centre or to any CENELEC member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by translation
under the responsibility of a CENELEC member into its own language and notified to the CEN-CENELEC Management Centre has the
same status as the official versions.
CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus, the Czech Republic,
Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the
Netherlands, Norway, Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.


European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2021 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
 Ref. No. EN IEC 60601-2-35:2021 E

---------------------- Page: 3 ----------------------
SIST EN IEC 80601-2-35:2021
EN IEC 60601-2-35:2021 (E)
European foreword
The text of document 62D/1765/FDIS, future edition 2 of IEC 60601-2-35, prepared by SC 62D
"Electromedical equipment" of IEC/TC 62 "Electrical equipment in medical practice" was submitted to
the IEC-CENELEC parallel vote and approved by CENELEC as EN IEC 60601-2-35:2021.
The following dates are fixed:
• latest date by which the document has to be implemented at national (dop) 2022-01-16
level by publication of an identical national
standard or by endorsement
• latest date by which the national standards conflicting with the (dow) 2024-07-16
document have to be withdrawn
This document supersedes EN 80601-2-35:2009 and all of its amendments and corrigenda (if an
...