EN ISO 7439:2009

Copper-bearing intra-uterine contraceptive devices - Requirements, tests (ISO 7439:2002)

This European Standard applies to single-use copper-containing contraceptive intrauterine devices and their insertion instruments. Contraceptive intrauterine devices consisting only of a plastics body and contraceptive intrauterine devices whose primary purpose is to release progestogens are not included in the scope of this standard.

Kupferhaltige Intrauterinpessare zur Empfängnisverhütung - Anforderungen, Prüfungen (ISO 7439:2002)

Diese Europäische Norm gilt für kupferhaltige Intrauterinpessare zur Empfängnisverhütung zum
Einmalgebrauch und ihre Einführinstrumente. Intrauterinpessare zur Empfängnisverhütung, die nur aus einem
Kunststoffkörper bestehen, und Intrauterinpessare zur Empfängnisverhütung, deren erstrangiger Zweck die
Freisetzung von Progestogenen ist, fallen nicht in den Anwendungsbereich dieser Norm.
ANMERKUNG Einige Aspekte dieser Norm können auch auf Intrauterinpessare angewendet werden, die Progestogene
freisetzen oder nur aus einem Kunststoffkörper bestehen.

Dispositifs intra-utérins contenant du cuivre - Exigences, essais (ISO 7439:2002)

Intrauterini kontracepcijski pripomočki z bakrenim nosilcem - Zahteve, preskusi (ISO 7439:2002)

General Information

• Status: Withdrawn
• Publication Date: 12-May-2009
• Withdrawal Date: 31-May-2011
• ICS: 11.200 - Birth control. Mechanical contraceptives
• Technical Committee: CEN/TC 285 - Non-active surgical implants
• Drafting Committee: CEN/TC 285/WG 7 - Intrauterine devices
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Start Date: 01-Jun-2011
• Completion Date: 01-Jun-2011
• Directive: 2007/47/EC - Directive 2007/47/EC of the European Parliament and of the council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: SIST EN ISO 7439:2009 - Copper-bearing intra-uterine contraceptive devices - Requirements, tests (ISO 7439:2002)

Relations

• Replaces: EN ISO 7439:2002 - Copper-bearing intra-uterine contraceptive devices - Requirements, tests (ISO 7439:2002)
• Effective Date: 22-Dec-2008
• Replaced By: EN ISO 7439:2011 - Copper-bearing contraceptive intrauterine devices - Requirements and tests (ISO 7439:2011)
• Effective Date: 17-Apr-2010

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 7439:2009
01-julij-2009
1DGRPHãþD
SIST EN ISO 7439:2002
SIST EN ISO 7439:2002/kprA1:2009
,QWUDXWHULQLNRQWUDFHSFLMVNLSULSRPRþNL]EDNUHQLPQRVLOFHP=DKWHYHSUHVNXVL
,62
Copper-bearing intra-uterine contraceptive devices - Requirements, tests (ISO
7439:2002)
Kupferhaltige Intrauterinpessare zur Empfängnisverhütung - Anforderungen, Prüfungen
(ISO 7439:2002)
Dispositifs intra-utérins contenant du cuivre - Exigences, essais (ISO 7439:2002)
Ta slovenski standard je istoveten z: EN ISO 7439:2009
ICS:
11.200 1DþUWRYDQMHGUXåLQH Birth control. Mechanical
0HKDQVNLNRQWUDFHSFLMVNL contraceptives
SULSRPRþNL
SIST EN ISO 7439:2009 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 7439:2009

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SIST EN ISO 7439:2009
EUROPEAN STANDARD
EN ISO 7439
NORME EUROPÉENNE
EUROPÄISCHE NORM
May 2009
ICS 11.200 Supersedes EN ISO 7439:2002
English Version
Copper-bearing intra-uterine contraceptive devices -
Requirements, tests (ISO 7439:2002)
Dispositifs intra-utérins contenant du cuivre - Exigences, Kupferhaltige Intrauterinpessare zur Empfängnisverhütung
essais (ISO 7439:2002) - Anforderungen, Prüfungen (ISO 7439:2002)
This European Standard was approved by CEN on 19 April 2009.
CEN 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 Management Centre or to any CEN 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 CEN member into its own language and notified to the CEN Management Centre has the same status as the
official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2009 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 7439:2009: E
worldwide for CEN national Members.

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SIST EN ISO 7439:2009
EN ISO 7439:2009 (E)
Contents Page
Foreword .3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC .4

2

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SIST EN ISO 7439:2009
EN ISO 7439:2009 (E)
Foreword
The text of ISO 7439:2002 has been prepared by Technical Committee ISO/TC 150 “Implants for surgery” of
the International Organization for Standardization (ISO) and has been taken over as EN ISO 7439:2009 by
Technical Committee CEN/TC 285 “Non-active surgical implants” the secretariat of which is held by DIN.
This European Standard shall be given the status of a national standard, either by publication of an identical
text or by endorsement, at the latest by November 2009, and conflicting national standards shall be withdrawn
at the latest by March 2010.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 7439:2002.
This document has been prepared under a mandate given to CEN by the European Commission and the
European Free Trade Association, and supports essential requirements of EC Directive.
For relationship with EC Directive, see informative Annex ZA, which is an integral part of this document.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following
countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Cyprus, Czech
Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain,
Sweden, Switzerland and the United Kingdom.
Endorsement notice
The text of ISO 7439:2002 has been approved by CEN as a E
...