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SIST EN 60601-2-21:2009/A1:2017

(Amendment)

Medical electrical equipment - Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers (IEC 60601-2-21:2009/A1:2016)

Medical electrical equipment - Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers (IEC 60601-2-21:2009/A1:2016)

Medizinische elektrische Geräte - Teil 2-21: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Säuglingswärmestrahlern

Appareils électromédicaux - Partie 2-21: Exigences particulières pour la sécurité de base et les performances essentielles des incubateurs radiants pour nouveau-nés

Medicinska električna oprema - 2-21. del: Posebne zahteve za osnovno varnost in bistvene lastnosti otroških sevalnih ogrevalnikov - Dopolnilo A1 (IEC 60601-2-21:2009/A1:2016)

General Information

Status
Published
Publication Date
10-Jan-2017
ICS
11.040.10 - Anaesthetic, respiratory and reanimation 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/432 - Standardisation Mandate addressed to CEN and CENELEC within the framework of Directive 2007/47/EC amending Directive 90/385/EEC and Directive 93/42/EEC relating to Medical Devices
Ref Project
EN 60601-2-21:2009/A1:2016 - Medical electrical equipment - Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers

Relations

Amends
SIST EN 60601-2-21:2009 - Medical electrical equipment - Part 2-21: Particular requirements for basic safety and essential performance of infant radiant warmers (IEC 60601-2-21:2009)
Effective Date
24-Mar-2015
Revised
SIST EN 60601-2-21:2009/A11:2012 - Medical electrical equipment - Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers
Effective Date
03-Mar-2015
Replaced By
SIST EN IEC 60601-2-21:2021 - Medical electrical equipment - Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers (IEC 60601-2-21:2020)
Effective Date
20-Jul-2021
Amends
SIST EN 60601-2-21:2009 - Medical electrical equipment - Part 2-21: Particular requirements for basic safety and essential performance of infant radiant warmers (IEC 60601-2-21:2009)
Effective Date
07-Jun-2022

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Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN 60601-2-21:2009/A1:2017
01-februar-2017
0HGLFLQVNDHOHNWULþQDRSUHPDGHO3RVHEQH]DKWHYH]DRVQRYQRYDUQRVWLQ
ELVWYHQHODVWQRVWLRWURãNLKVHYDOQLKRJUHYDOQLNRY'RSROQLOR$ ,(&
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Medical electrical equipment - Part 2-21: Particular requirements for the basic safety and
essential performance of infant radiant warmers (IEC 60601-2-21:2009/A1:2016)
Medizinische elektrische Geräte - Teil 2-21: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von Säuglingswärmestrahlern
Appareils électromédicaux - Partie 2-21: Exigences particulières pour la sécurité de base
et les performances essentielles des incubateurs radiants pour nouveau-nés
Ta slovenski standard je istoveten z: EN 60601-2-21:2009/A1:2016
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
SIST EN 60601-2-21:2009/A1:2017 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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

SIST EN 60601-2-21:2009/A1:2017

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

SIST EN 60601-2-21:2009/A1:2017


EUROPEAN STANDARD EN 60601-2-21:2009/A1

NORME EUROPÉENNE

EUROPÄISCHE NORM
December 2016
ICS 11.040.10

English Version
Medical electrical equipment - Part 2-21: Particular requirements
for the basic safety and essential performance of infant radiant
warmers
(IEC 60601-2-21:2009/A1:2016)
Appareils électromédicaux - Partie 2-21: Exigences Medizinische elektrische Geräte - Teil 2-21: Besondere
particulières pour la sécurité de base et les performances Festlegungen für die Sicherheit einschließlich der
essentielles des incubateurs radiants pour nouveau-nés wesentlichen Leistungsmerkmale von
(IEC 60601-2-21:2009/A1:2016) Säuglingswärmestrahlern
(IEC 60601-2-21:2009/A1:2016)
This amendment A1 modifies the European Standard EN 60601-2-21:2009; 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 60601-2-21:2009/A1:2016 E

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

SIST EN 60601-2-21:2009/A1:2017
EN 60601-2-21:2009/A1:2016
European foreword
The text of document 62D/1326/FDIS, future IEC 60601-2-21:2009/A1, 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 60601-2-21:2009/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 60601-2-21:2009/A11:2011.
Endorsement notice
The text of the International Standard IEC 60601-2-21:2009/A1:2016 was approved by CENELEC as
a European Standard without any modification.
In the Bibliography of EN 60601-2-21:2009, the following note has to be added for the standard indicated :
ISO 80601-2-56 NOTE Harmonized as EN ISO 80601-2-56.
In the Bibliography of EN 60601-2-21:2009, the following note has to be deleted for the standard indicated:
ISO 3743-1 NOTE Harmonized as EN ISO 3743-1:1995 (not modified).
2

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

SIST EN 60601-2-21:2009/A1:2017
EN 60601-2-21:2009/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 60601-2-21:2009, replace the existing reference to IEC 60601-1-2:2007 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
In Annex ZA of EN 60601-2-21:2009, delete IEC 60601-1-10:2007.

3

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SIST EN 60601-2-21:2009/A1:2017

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

SIST EN 60601-2-21:2009/A1:2017



IEC 60601-2-21

®


Edition 2.0 2016-04




INTERNATIONAL



STANDARD




NORME



INTERNATIONALE




AM ENDMENT 1

AM ENDEMENT 1





Medical electrical equipment –

Part 2-21: Particular requirements for the basic safety and essential performance

of infant radiant warmers




Appareils électromédicaux –

Partie 2-21: Exigences particulières pour la sécurité de base et les performances


essentielles des incubateurs radiants pour nouveau-nés













INTERNATIONAL

ELECTROTECHNICAL

COMMISSION


COMMISSION

ELECTROTECHNIQUE


INTERNATIONALE




ICS 11.040.10 ISBN 978-2-8322-3344-3



Warning! Make sure that you obtained this publication from an authorized distributor.

Attention! Veuillez vous assurer que vous avez obtenu cette publication via un distributeur agréé.

® Registered trademark of the International Electrotechnical Commission
Marque déposée de la Commission Electrotechnique Internationale

---------------------- Page: 7 ----------------------

SIST EN 60601-2-21:2009/A1:2017
– 2 – IEC 60601-2-21:2009/AMD1:2016
© IEC 2016
FOREWORD
This amendment has been prepared by subcommittee 62D: Electromedical equipment of IEC
technical committee 62: Electrical equipment in medical practice.
The text of this amendment is based on the following documents:
FDIS Report on voting
62D/1326/FDIS 62D/1347/RVD

Full information on the voting for the approval of this amendment can be found in the report
on voting indicated in the above table.
The committee has decided that the contents of this amendment and the base publication will
remain unchanged until the stability date indicated on the IEC website under
"http://webstore.iec.ch" in the data related to the specific publication. At this date, the
publication wil
...

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