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

This standard specifies requirements for information to be supplied by a manufacturer for medical devices regulated by Council Directive 90/385/EEC relating to active implantable medical devices and Council Directive 93/42/EEC concerning medical devices. It does not specify the language to be used for such information, nor does it specify the means by which the information is to be supplied. It is also intended to complement the specific requirements of the cited EU Directives on medical devices by providing guidance on means by which certain requirements can be met. If a manufacturer follows these means, they will provide a presumption of conformity with the relevant Essential Requirements regarding information to be supplied.
This standard does not cover requirements for provision of information for in vitro diagnostic medical devices, which are covered by other labelling standards (see Bibliography).
NOTE   When national transpositions of the Directives specify the means by which information shall be supplied, this standard does not provide derogation from these requirements for that country.

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.

Rigidité diélectrique des matériaux isolants - Méthodes d’essai -- Partie 3: Exigences complémentaires pour les essais aux ondes de choc 1,2/50 µs

La présente norme spécifie les exigences concernant les informations à fournir par un fabricant de dispositifs médicaux d’après la réglementation dictée par la Directive du Conseil 90/385/CEE relative aux dispositifs médicaux implantables actifs et par la Directive du Conseil 93/42/CEE concernant les dispositifs médicaux. Elle ne spécifie pas la langue à utiliser pour ces informations ni les moyens par lesquels les informations sont fournies. Elle a également pour but de venir compléter les exigences spécifiques des Directives UE sur les dispositifs médicaux citées en donnant des indications sur la manière dont certaines exigences peuvent être satisfaites. Si un fabricant suit ces indications, celles-ci laissent à présumer de la conformité aux exigences essentielles relatives à la fourniture d'informations.
La présente norme ne couvre pas les exigences concernant la fourniture d’informations pour les dispositifs médicaux de diagnostic in vitro qui font l'objet d'autres normes d'étiquetage (voir Bibliographie).
NOTE   Lorsque des transpositions nationales des directives précisent les moyens par lesquels les informations doivent être fournies, la présente norme ne propose pas de dérogation à ces exigences pour un pays particulier.

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
05-Mar-2014
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
27-Feb-2014
Due Date
04-May-2014
Completion Date
06-Mar-2014

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SLOVENSKI STANDARD
01-april-2014
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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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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
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.

- 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

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

– 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

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
1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising
all national electrotechnical committees (IEC National Committees). The object of IEC is to promote
international co-operation on all questions concerning standardization in the electrical and electronic fields. To
this end and in addition to other activities, IEC publishes International Standards, Technical Specifications,
Technical Reports, Publicly Available Specifications (PAS) and Guides (hereafter referred to as “IEC
Publication(s)”). Their preparation is entrusted to technical committees; any IEC National Committee interested
in the subject dealt with may participate in this preparatory work. International, governmental and non-
governmental organizations liaising with the IEC also participate in this preparation. IEC collaborates closely
with the International Organization for Standardization (ISO) in accordance with conditions determined by
agreement between the two organizations.
2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international
consensus of opinion on the relevant subjects since each technical committee has representation from all
interested IEC National Committees.
3) IEC Publications have the form of recommendations for international use and are accepted by IEC National
Committees in that sense. While all reasonable efforts are made to ensure that the technical content of IEC
Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any
misinterpretation by any end user.
4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications
transparently to the maximum extent possible in their national and regional publications. Any divergence
between any IEC Publication and the corresponding national or regional publication shall be clearly indicated in
the latter.
5) IEC itself does not provide any attestation of conformity. Independent certification bodies provide conformity
assessment services and, in some areas, access to IEC marks of conformity. IEC is not responsible for any
services carried out by independent certification bodies.
6) All users should ensure that they have the latest edition of this publication.
7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and
members of its technical committees and IEC National Committees for any personal injury, property damage or
other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and
expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC
Publications.
8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is
indispensable for the correct application of this publication.
9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of
patent rights. IEC shall not be held responsible for identifying any or all such patent rights.
International Standard IEC 60243-3 has been prepared by technical committee 112: Evaluation
and qualification of electrical insulation materials and systems.
This third edition cancels and replaces the second edition, published in 2001, and constitutes
an editorial revision.
This part of IEC 60243 shall be read in conjunction with IEC 60243-1.
The text of this standard is based on the following documents:
CDV Report on voting
112/246/CDV 112/267A/RVC
– 4 – 60243-3 © IEC:2013
Full information on the voting for the approval of this standard can be found in the report on
voting indicated in the above table.
This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.
A list of all parts in the IEC 60243 series, published under the general title Electric strength of
insulating materials – Test methods, can be found on the IEC website.
The committee has decided that the contents of this publication will remain unchanged until the
stability date indicated on the IEC web site 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.
60243-3 © IEC:2013 – 5 –
ELECTRIC STRENGTH OF INSULATING MATERIALS –
TEST METHODS –
Part 3: Additional requirements for 1,2/50 µs impulse tests

1 Scope
This part of IEC 60243 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.
2 Normative references
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.
IEC 60243-1:2013, Electric strength of insulating materials – Test methods – Part 1: Tests at
power frequencies
3 Terms and definitions
For the purposes of this document, the terms and definitions given in IEC 60243-1, together
with the following, apply.
3.1
full impulse-voltage wave
aperiodic transient voltage that rises rapidly to a maximum value, then falls less rapid
...

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