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SIST EN 60601-2-19:2009/A1:2017

(Amendment)

Medical electrical equipment - Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators (IEC 60601-2-19:2009/A1:2016)

Medical electrical equipment - Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators (IEC 60601-2-19:2009/A1:2016)

Medizinische elektrische Geräte - Teil 2-19: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Säuglingsinkubatoren

Appareils électromédicaux - Partie 2-19: Exigences particulières pour la sécurité de base et les performances essentielles des incubateurs pour nouveau-nés

Medicinska električna oprema - 2-19. del: Posebne zahteve za osnovno varnost in bistvene lastnosti otroških inkubatorjev - Dopolnilo A1 (IEC 60601-2-19:2009/A1:2016)

General Information

Status
Withdrawn
Publication Date
09-Jan-2017
Withdrawal Date
29-Jul-2024
ICS
11.040.10 - Anaesthetic, respiratory and reanimation equipment
Technical Committee
IEMO - Electrical equipment in medical practice
Current Stage
9900 - Withdrawal (Adopted Project)
Start Date
30-Jul-2024
Due Date
22-Aug-2024
Completion Date
30-Jul-2024
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 60601-2-19:2009/A1:2016 - Medical electrical equipment - Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators

Relations

Replaced By
SIST EN IEC 60601-2-19:2021 - Medical electrical equipment - Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators (IEC 60601-2-19:2020)
Effective Date
20-Jul-2021
Amends
SIST EN 60601-2-19:2009 - Medical electrical equipment - Part 2-19: Particular requirements for basic safety and essential performance of baby incubators (IEC 60601-2-19)
Effective Date
07-Jun-2022
Amends
SIST EN 60601-2-19:2009 - Medical electrical equipment - Part 2-19: Particular requirements for basic safety and essential performance of baby incubators (IEC 60601-2-19)
Effective Date
24-Mar-2015
Revised
SIST EN 60601-2-19:2009/A11:2012 - Medical electrical equipment - Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators
Effective Date
03-Mar-2015

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EN 60601-2-19:2009/A1:2017EN 60601-2-19:2009/A1:2017
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EN 60601-2-19:2009/A1:2017
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Standards Content (Sample)


SLOVENSKI STANDARD
01-februar-2017
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Medical electrical equipment - Part 2-19: Particular requirements for the basic safety and
essential performance of infant incubators (IEC 60601-2-19:2009/A1:2016)
Medizinische elektrische Geräte - Teil 2-19: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von Säuglingsinkubatoren
Appareils électromédicaux - Partie 2-19: Exigences particulières pour la sécurité de base
et les performances essentielles des incubateurs pour nouveau-nés
Ta slovenski standard je istoveten z: EN 60601-2-19:2009/A1:2016
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD EN 60601-2-19:2009/A1

NORME EUROPÉENNE
EUROPÄISCHE NORM
December 2016
ICS 11.040.10
English Version
Medical electrical equipment - Part 2-19: Particular requirements
for the basic safety and essential performance of infant
incubators
(IEC 60601-2-19:2009/A1:2016)
Appareils électromédicaux - Partie 2-19: Exigences Medizinische elektrische Geräte - Teil 2-19: Besondere
particulières pour la sécurité de base et les performances Festlegungen für die Sicherheit einschließlich der
essentielles des incubateurs pour nouveau-nés wesentlichen Leistungsmerkmale von Säuglingsinkubatoren
(IEC 60601-2-19:2009/A1:2016) (IEC 60601-2-19:2009/A1:2016)
This amendment A1 modifies the European Standard EN 60601-2-19:2009; 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 60601-2-19:2009/A1:2016 E

European foreword
The text of document 62D/1324/FDIS, future IEC 60601-2-19:2009/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 60601-2-19:2009/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 60601-2-19:2009/A11:2011.
Endorsement notice
The text of the International Standard IEC 60601-2-19:2009/A1:2016 was approved by CENELEC as
a European Standard without any modification.
In the Bibliography of EN 60601-2-19:2009, the following note has to be added for the standard indicated :
ISO 80601-2-56 NOTE Harmonized as EN ISO 80601-2-56.
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 60601-2-19:2009, 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 60601-2-19:2009, delete IEC 60601-1-10:2007.

IEC 60601-2-19 ®
Edition 2.0 2016-04
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
AM ENDMENT 1
AM ENDEMENT 1
Medical electrical equipment –

Part 2-19: Particular requirements for the basic safety and essential performance

of infant incubators
Appareils électromédicaux –
Partie 2-19: Exigences particulières pour la sécurité de base et les performances

essentielles des incubateurs pour nouveau-nés

INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 11.040.10 ISBN 978-2-8322-3342-9

– 2 – IEC 60601-2-19:2009/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/1324/FDIS 62D/1345/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 will be
• reconfirmed,
• withdrawn,
• replaced by a revised edition, or
• amended.
_____________
INTRODUCTION
Replace, in the second paragraph, “IEC 60601-1:2005” by “IEC 60601-1”.
201.1 Scope, object and related standards
Replace, in footnote 1), “IEC 60601-1:2005” by “IEC 60601-1”.
201.1.3 * Collateral standards
Delete the asterisk (*) from the title.
Replace the second paragraph by the following text:
IEC 60601-1-2 applies as modified in Clause 202. IEC 60601-1-3 and IEC 60601-1-10 do no
...

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