EN 1041:2008

Information supplied by the manufacturer of medical devices

IEC 60243-3:2013 gives requirements additional to those in IEC 60243-1 for the determination of the electric strength of solid insulating materials under 1,2/50 µs impulse voltage stress. This third edition cancels and replaces the second edition, published in 2001, and constitutes an editorial revision.

Bereitstellung von Informationen durch den Hersteller von Medizinprodukten

Die vorliegende Norm legt Anforderungen an Informationen fest, die von einem Hersteller für Medizinprodukte nach der EU-Richtlinie 90/385/EWG zu aktiven implantierbaren medizinischen Geräten und EU-Richtlinie 93/42/EWG zu Medizinprodukten zur Verfügung zu stellen sind. Es werden weder die verwendete Sprache für diese Informationen noch die Mittel festgelegt, mit denen die Informationen zu geben sind. Es ist ferner beabsichtigt, die besonderen Anforderungen der genannten EU-Richtlinien zu Medizinprodukten durch die Bereitstellung einer Anleitung zu ergänzen, wie bestimmte Anforderungen erfüllt werden können. Wenn diese Hinweise von einem Hersteller befolgt werden, so liefern sie eine Annahme der Übereinstimmung mit den relevanten grundlegenden Anforderungen hinsichtlich der bereitzustellenden Information.
Die vorliegende Norm schließt keine Anforderungen an die Bereitstellung von Informationen für In-vitro-Diag¬nostika ein, die von anderen genannten Normen abgedeckt werden (siehe Literaturhinweise).
ANMERKUNG   Sofern nationale Umstellungen der Richtlinien die Mittel festlegen, mit denen Informationen zur Verfügung zu stellen sind, führt die vorliegende Norm nicht zu einer teilweisen Aufhebung dieser Anforderungen für das bestimmte Land.

Informations fournies par le fabricant de dispositifs médicaux

L'IEC 60243-3:2013 donne des exigences complémentaires à celles de la CEI 60243-1 pour la détermination de la rigidité diélectrique des matériaux isolants solides soumis à des tensions de choc 1,2/50 µs. Cette troisième édition annule et remplace la deuxième édition parue en 2001, et constitue une révision éditoriale.

Električna trdnost izolacijskih snovi - Preskusne metode - 3. del: Dodatne zahteve za preskušanje z 1,2/50 µs napetostnimi impulzi (IEC 60243-3:2013)

General Information

• Status: Published
• Publication Date: 20-Feb-2014
• ICS: 17.220.99 - Other standards related to electricity and magnetism
• ICS: 29.035.01 - Insulating materials in general
• Technical Committee: CLC/SR 112 - Evaluation and qualification of electrical insulating materials and systems (to be defined)
• Drafting Committee: IEC/TC 112 - IEC_TC_112
• Current Stage: 6060 - Document made available - Publishing
• Due Date: 21-Feb-2014
• Completion Date: 21-Feb-2014
• Ref Project: SIST EN 60243-3:2014 - Electric strength of insulating materials - Test methods - Part 3: Additional requirements for 1,2/50 µs impulse tests

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN 60243-3:2014
01-april-2014
1DGRPHãþD
SIST EN 60243-3:2002
(OHNWULþQDWUGQRVWL]RODFLMVNLKVQRYL3UHVNXVQHPHWRGHGHO'RGDWQH]DKWHYH
]DSUHVNXãDQMH]—VQDSHWRVWQLPLLPSXO]L,(&
Electric strength of insulating materials - Test methods - Part 3: Additional requirements
for 1,2/50 µs impulse tests
Rigidité diélectrique des matériaux isolants - Méthodes d’essai -- Partie 3: Exigences
complémentaires pour les essais aux ondes de choc 1,2/50 µs
Ta slovenski standard je istoveten z: EN 60243-3:2014
ICS:
17.220.99 Drugi standardi v zvezi z Other standards related to
elektriko in magnetizmom electricity and magnetism
29.035.01 Izolacijski materiali na Insulating materials in
splošno general
SIST EN 60243-3:2014 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN 60243-3:2014

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SIST EN 60243-3:2014

EUROPEAN STANDARD
EN 60243-3

NORME EUROPÉENNE
February 2014
EUROPÄISCHE NORM

ICS 17.220.99; 29.035.01 Supersedes EN 60243-3:2001


English version


Electric strength of insulating materials -
Test methods -
Part 3: Additional requirements for 1,2/50 µs impulse tests
(IEC 60243-3:2013)


Rigidité diélectrique des matériaux Elektrische Durchschlagfestigkeit von
isolants - Méthodes d’essai - isolierenden Werkstoffen -
Partie 3: Exigences complémentaires pour Prüfverfahren -
les essais aux ondes de choc 1,2/50 µs Teil 3: Zusätzliche Festlegungen für
(CEI 60243-3:2013) 1,2/50 µs Stoßspannungsprüfungen
(IEC 60243-3:2013)





This European Standard was approved by CENELEC on 2013-12-31. 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, 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.

CENELEC
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


© 2014 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members.
Ref. No. EN 60243-3:2014 E

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SIST EN 60243-3:2014
EN 60243-3:2014 - 2 -
Foreword
The text of document 112/246/CDV, future edition 3 of IEC 60243-3, prepared by
IEC/TC 112 "Evaluation and qualification of electrical insulation materials and systems" was submitted
to the IEC-CENELEC parallel vote and approved by CENELEC as EN 60243-3:2014.

The following dates are fixed:
(dop) 2014-09-30
• latest date by which the document has to be
implemented at national level by
publication of an identical national
standard or by endorsement
• latest date by which the national (dow) 2016-12-31
standards conflicting with the
document have to be withdrawn

This document supersedes EN 60243-3:2001.

This standard shall be read in conjunction with EN 60243-1.

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.

Endorsement notice
The text of the International Standard IEC 60243-3:2013 was approved by CENELEC as a European
Standard without any modification.

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SIST EN 60243-3:2014
- 3 - EN 60243-3:2014
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  When an international publication has been modified by common modifications, indicated by (mod), the relevant EN/HD
applies.

Publication Year Title EN/HD Year

IEC 60243-1 2013 Electric strength of insulating materials - EN 60243-1 2013
Test methods -
Part 1: Tests at power frequencies

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SIST EN 60243-3:2014

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SIST EN 60243-3:2014



IEC 60243-3

®


Edition 3.0 2013-11




INTERNATIONAL



STANDARD




NORME



INTERNATIONALE











Electric strength of insulating materials – Test methods –

Part 3: Additional requirements for 1,2/50 µs impulse tests




Rigidité diélectrique des matériaux isolants – Méthodes d’essai –

Partie 3: Exigences complémentaires pour les essais

aux ondes de choc 1,2/50 µs
















INTERNATIONAL

ELECTROTECHNICAL

COMMISSION


COMMISSION

ELECTROTECHNIQUE

PRICE CODE
INTERNATIONALE

CODE PRIX J


ICS 17.220.99; 29.035.01 ISBN 978-2-8322-1201-1



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 60243-3:2014
– 2 – 60243-3 © IEC:2013
CONTENTS
FOREWORD . 3
1 Scope . 5
2 Normative references . 5
3 Terms and definitions . 5
4 Significance of the test . 6
5 Electrodes and test specimens . 7
6 Conditioning before tests . 7
7 Surrounding medium . 7
8 Electrical apparatus . 7
8.1 Voltage source . 7
8.2 Voltage measurement . 8
9 Procedure . 8
10 Application of voltage . 8
10.1 Breakdown test . 8
10.2 Proof tests . 8
11 Criterion of breakdown . 9
12 Number of tests . 9
13 Report . 9

Figure 1 – Full impulse-voltage wave . 6

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SIST EN 60243-3:2014
60243-3 © IEC:2013 – 3 –
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________

ELECTRIC STRENGTH OF INSULATING MATERIALS –
TEST METHODS –

Part 3: Additional requirements for 1,2/50 µs impulse tests

FOREWORD
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