EN ISO 7439:2011

Copper-bearing contraceptive intrauterine devices - Requirements and tests (ISO 7439:2011)

ISO 7439:2010 specifies requirements and tests for single-use, copper-bearing contraceptive intrauterine devices (IUDs) and their insertion instruments. (Some aspects can be applicable to medicated intrauterine devices and IUDs not containing copper.)
It is not applicable to IUDs consisting only of a plastics body or whose primary purpose is to release progestogens.

Kupferhaltige Intrauterinpessare zur Empfängnisverhütung - Anforderungen, Prüfungen (ISO 7439:2011)

Diese Internationale Norm legt Anforderungen und Prüfungen für kupferhaltige Intrauterinpessare zur Empfängnisverhütung (en: intrauterine devices, IUD) zum Einmalgebrauch und ihre Einführinstrumente fest. Intrauterinpessare, die nur aus einem Kunststoffkörper bestehen oder deren erstrangiger Zweck die Freisetzung von Progestogenen ist, fallen nicht in den Anwendungsbereich dieser Norm. ANMERKUNG Einige Aspekte dieser Internationalen Norm können auch auf Arzneistoffe enthaltende Intrauterinpessare und nicht-kupferhaltige Intrauterinpessare angewendet werden.

Dispositifs intra-utérins contenant du cuivre - Exigences, essais (ISO 7439:2011)

L'ISO 7439:2011 spécifie les exigences et essais relatifs aux dispositifs contraceptifs intra-utérins à usage unique contenant du cuivre et à leurs systèmes d'insertion.
Elle ne s'applique pas aux dispositifs intra-utérins ayant seulement un corps en plastique ni à ceux dont le but principal est la libération de progestatifs.

Intrauterini kontracepcijski pripomočki z bakrenim nosilcem - Zahteve in preskusi (ISO 7439:2011)

Ta mednarodni standard določa zahteve in preskuse za intrauterine kontracepcijske pripomočke z bakrenimi nosilci (IUD) in njihove instrumente za vstavljanje. Ne velja za IUD, sestavljene samo iz plastičnega telesa, ali katerih glavni namen je sproščanje progestogenov.

General Information

• Status: Withdrawn
• Publication Date: 31-May-2011
• Withdrawal Date: 14-Apr-2015
• ICS: 11.200 - Birth control. Mechanical contraceptives
• Technical Committee: CEN/TC 285 - Non-active surgical implants
• Drafting Committee: CEN/TC 285 - Non-active surgical implants
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Completion Date: 15-Apr-2015
• 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 7439:2011 - Copper-bearing contraceptive intrauterine devices - Requirements and tests (ISO 7439:2011)

Relations

• Replaces: EN ISO 7439:2009 - Copper-bearing intra-uterine contraceptive devices - Requirements, tests (ISO 7439:2002)
• Effective Date: 17-Apr-2010
• Replaced By: EN ISO 7439:2015 - Copper-bearing contraceptive intrauterine devices - Requirements and tests (ISO 7439:2015)
• Effective Date: 22-Apr-2015

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 7439:2011
01-oktober-2011
1DGRPHãþD
SIST EN ISO 7439:2002/kprA1:2009
SIST EN ISO 7439:2009
,QWUDXWHULQLNRQWUDFHSFLMVNLSULSRPRþNL]EDNUHQLPQRVLOFHP=DKWHYHLQSUHVNXVL
,62
Copper-bearing contraceptive intrauterine devices - Requirements and tests (ISO
7439:2011)
Kupferhaltige Intrauterinpessare zur Empfängnisverhütung - Anforderungen, Prüfungen
(ISO 7439:2011)
Dispositifs intra-utérins contenant du cuivre - Exigences, essais (ISO 7439:2011)
Ta slovenski standard je istoveten z: EN ISO 7439:2011
ICS:
11.200 1DþUWRYDQMHGUXåLQH Birth control. Mechanical
0HKDQVNLNRQWUDFHSFLMVNL contraceptives
SULSRPRþNL
SIST EN ISO 7439:2011 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 7439:2011

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SIST EN ISO 7439:2011


EUROPEAN STANDARD
EN ISO 7439

NORME EUROPÉENNE

EUROPÄISCHE NORM
June 2011
ICS 11.200 Supersedes EN ISO 7439:2009
English Version
Copper-bearing contraceptive intrauterine devices -
Requirements and tests (ISO 7439:2011)
Dispositifs intra-utérins contenant du cuivre - Exigences, Kupferhaltige Intrauterinpessare zur Empfängnisverhütung
essais (ISO 7439:2011) - Anforderungen, Prüfungen (ISO 7439:2011)
This European Standard was approved by CEN on 31 May 2011.

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-CENELEC 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-CENELEC Management Centre has the same
status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, 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
© 2011 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 7439:2011: E
worldwide for CEN national Members.

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SIST EN ISO 7439:2011
EN ISO 7439:2011 (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 7439:2011
EN ISO 7439:2011 (E)
Foreword
This document (EN ISO 7439:2011) has been prepared by Technical Committee ISO/TC 157 "Non-systemic
contraceptives and STI barrier prophylactics" in collaboration with 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 December 2011, and conflicting national standards shall be withdrawn
at the latest by December 2011.
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 7439:2009.
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 EU Directive.
For relationship with EU 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, Croatia, 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
...