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)

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

Medicinska električna oprema - 2-35. del: Posebne zahteve za osnovno varnost in bistvene lastnosti za rjuhe, blazine in posteljne vložke, namenjene za ogrevanje pri medicinski uporabi - Dopolnilo A1 (IEC 80601-2-35:2009/A1:2016)

General Information

• Status: Published
• Publication Date: 10-Jan-2017
• ICS: 11.140 - Hospital equipment
• Technical Committee: IEMO - Electrical equipment in medical practice
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 04-Jan-2017
• Due Date: 11-Mar-2017
• Completion Date: 11-Jan-2017
• 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 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

Relations

• Amends: 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: 24-Mar-2015
• Revised: 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: 10-Mar-2015
• Replaced By: 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)
• Effective Date: 20-Jul-2021
• Amends: 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

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN 80601-2-35:2010/A1:2017
01-februar-2017
0HGLFLQVNDHOHNWULþQDRSUHPDGHO3RVHEQH]DKWHYH]DRVQRYQRYDUQRVWLQ
ELVWYHQHODVWQRVWL]DUMXKHEOD]LQHLQSRVWHOMQHYORåNHQDPHQMHQH]DRJUHYDQMHSUL
PHGLFLQVNLXSRUDEL'RSROQLOR$,(&$
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)
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
Ta slovenski standard je istoveten z: EN 80601-2-35:2009/A1:2016
ICS:
11.140 Oprema bolnišnic Hospital equipment
SIST EN 80601-2-35:2010/A1:2017 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------

SIST EN 80601-2-35:2010/A1:2017

---------------------- Page: 2 ----------------------

SIST EN 80601-2-35:2010/A1:2017


EUROPEAN STANDARD EN 80601-2-35:2009/A1

NORME EUROPÉENNE

EUROPÄISCHE NORM
December 2016
ICS 11.040.01

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/A1:2016)
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 80601-2-35:2009/A1:2016) (IEC 80601-2-35:2009/A1:2016)
This amendment A1 modifies the European Standard EN 80601-2-35:2009; it was approved by CENELEC on 2016-06-03. CENELEC
members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this amendment 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 amendment 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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, 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: Avenue Marnix 17, B-1000 Brussels
© 2016 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
 Ref. No. EN 80601-2-35:2009/A1:2016 E

---------------------- Page: 3 ----------------------

SIST EN 80601-2-35:2010/A1:2017
EN 80601-2-35:2009/A1:2016
European foreword
The text of document 62D/1328/FDIS, future IEC 80601-2-35:2009/A1, 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 approved by CENELEC as
EN 80601-2-35:2009/A1:2016.
The following dates are fixed:
(dop) 2017-06-16
• latest date by which the document has to be implemented at
national level by publication of an identical national
standard or by endorsement
(dow) 2019-12-16
• latest date by which the national standards conflicting with
the document have to be withdrawn

Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CENELEC [and/or CEN] shall not be held responsible for identifying any or all such
patent rights.
This document has been prepared under a mandate given to CENELEC by the European Commission
and the European Free Trade Association, and supports essential requirements of EU Directive(s).
For the relationship with EU Directive 93/42/EEC, see informative Annex ZZ, included in
EN 80601-2-35:2009/A11:2011.
Endorsement notice
The text of the International Standard IEC 80601-2-35:2009/A1:2016 was approved by CENELEC as
a European Standard without any modification.
In the Bibliography of EN 80601-2-35:2009, replace the existing references [10], [11] and [12] by the following:
[10] IEC 60601-2-19 NOTE Harmonized as EN 60601-2-19.
[11] IEC 60601-2-20 NOTE Harmonized as EN 60601-2-20.
[12] IEC 60601-2-21 NOTE Harmonized as EN 60601-2-21.
2

---------------------- Page: 4 ----------------------

SIST EN 80601-2-35:2010/A1:2017
EN 80601-2-35:2009/A1:2016
Annex ZA
(normative)

Normative references to international publications
with their corresponding European publications
The following documents, in whole or in part, are normatively referenced in this document and are
indispensable for its application. For dated references, only the edition cited applies. For undated
references, the latest edition of the referenced document (including any amendments) applies.
NOTE 1 When 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.

Publication Year Title EN/HD Year
In Annex ZA of EN 80601-2-35:2009, replace the existing references to IEC 60601-1-2:2007,
IEC 60601-1-8:2006 and IEC 60601-1-10:2007 as follows:
IEC 60601-1-2 -  Medical electrical equipment - EN 60601-1-2 2015
Part 1-2: General requirements for basic
safety and essential performance -
Collateral standard: Electromagnetic
disturbances - Requirements and tests
IEC 60601-1-8 -  Medical electrical equipment - EN 60601-1-8 2007
Part 1-8: General requirements for basic
 + corr. Mar. 2010
safety and essential performance -
 Collateral Standard: General + A1 2013
requirements, tests and guidance for
 + A1/AC 2014
alarm systems in medical electrical
equipment and medical electrical
systems
IEC 60601-1-10 -  Medical electrical equipment - EN 60601-1-10 2008
Part 1-10: General requirements for
 + A1 2015
basic safety and essential performance -
Collateral Standard: Requirements for
the development of physiologic closed-
loop controllers
In Annex ZA of EN 80601-2-35:2009, delete ISO 3743-1.

3

---------------------- Page: 5 ----------------------

SIST EN 80601-2-35:2010/A1:2017

---------------------- Page: 6 ----------------------

SIST EN 80601-2-35:2010/A1:2017



IEC 80601-2-35


Edition 2.0 2016-04




INTERNATIONAL



STANDARD




NORME



INTERNATIONALE




AM ENDMENT 1

AM ENDEMENT 1





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

ELEC
...