SIST EN ISO 7439:2002

SLOVENSKI STANDARD
SIST EN ISO 7439:2002
01-november-2002
,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 7439:2002
ICS:
11.200 1DþUWRYDQMHGUXåLQH Birth control. Mechanical
0HKDQVNLNRQWUDFHSFLMVNL contraceptives
SULSRPRþNL
SIST EN ISO 7439:2002 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------

SIST EN ISO 7439:2002

---------------------- Page: 2 ----------------------

SIST EN ISO 7439:2002
EUROPEAN STANDARD
EN ISO 7439
NORME EUROPÉENNE
EUROPÄISCHE NORM
March 2002
ICS 11.200
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 20 April 2001.
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 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 Management Centre has the same status as the official
versions.
CEN members are the national standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece,
Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36  B-1050 Brussels
© 2002 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 7439:2002 E
worldwide for CEN national Members.

---------------------- Page: 3 ----------------------

SIST EN ISO 7439:2002
EN ISO 7439:2002 (E)
Contents
3
Foreword.
3
Introduction
.........................................................................................................................................................
1 Scope 3
......................................................................................................................................................
2 Normative references 4
...............................................................................................................................
3 Terms and definitions 4
...............................................................................................................................
4 Intended performance 5
..............................................................................................................................
5 Design attributes 5
......................................................................................................................................
6 Materials 6
..................................................................................................................................................
7 Design evaluation 6
.....................................................................................................................................
8 Manufacturing and inspection 10
.................................................................................................................
9 Sterilization 10
............................................................................................................................................
10 Packaging 10
..............................................................................................................................................
11 Information supplied by the manufacturer 10
...............................................................................................
Bibliography 15
........................................................................................................................................................
2

---------------------- Page: 4 ----------------------

SIST EN ISO 7439:2002
EN ISO 7439:2002 (E)
Foreword
This document (EN ISO 7439:2002) has been prepared by Technical Committee CEN/TC 285 "Non-active surgical
implants", the secretariat of which is held by NEN in collaboration with Technical Committee ISO/TC 157
"Mechanical contraceptives".
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 September 2002, and conflicting national standards shall be withdrawn at the
latest by September 2002.
This European Standard needs to be considered in conjunction with EN ISO 14630, which contains requirements that
apply to all non-active surgical implants. Although contraceptive intra-uterine devices are not surgical implants, most of
the requirements of EN ISO 14630 may be applicable to contraceptive intra-uterine devices.
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(s).
For relationship with EU Directive(s), 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, Czech Republic, Denmark, Finland,
France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, Spain,
Sweden, Switzerland and the United Kingdom.
Introduction
Although every object in the uterus exhibits a certain contraceptive effect, the method by which copper-bearing
foreign
intra-uterine contraceptive devices (IUDs) function is by the continuous release of copper ions. This interferes with
some enzymatic functions, immobilizes sperm cells and inhibits fertilization. In addition, growth and development of
the ovum, tubal function and implantation are inhibited and the biochemical environment of the uterus is altered. These
contribute to the high effectiveness of contraception.
The effectiveness of copper-bearing contraceptive intra-uterine devices is many times greater than that of a simple
plastics body.
Contraceptive intra-uterine devices containing copper are regarded as medical devices incorporating a substance with
an ancillary action and are subject to Council Directive 93/42/EEC of 14 June 1993 concerning medical devices.
Contraceptive intra-uterine devices whose primary purpose is to release progestogens are regulated as medicinal
products and are subject to Council Directive 65/65/EEC of 26 January 1965 on the approximation of provisions laid
down by law, regulation or administrative action relating to proprietary medicinal products. The relevant essential
requirements of Annex I to Directive 93/42/EEC apply as far as safety and performance-related device features are
concerned.
1 Scope
This European Standard applies to single-use copper-bearing intra-uterine contraceptive devices and their insertion
instruments. Intra-uterine contraceptive devices consisting only of a plastics body and intra-uterine contraceptive
devices whose primary purpose is to release progestogens are not included in the scope of this standard.
NOTE Some aspects of this standard can be applicable to medicated intra-uterine devices and intra-uterine devices that do not
contain copper.
3

---------------------- Page: 5 ----------------------

SIST EN ISO 7439:2002
EN ISO 7439:2002 (E)
2 Normative references
This European Standard incorporates by dated or undated reference provisions from other publications. These
normative references are cited at the appropriate places in the text and the publications are listed hereafter. For dated
references, subsequent amendments to, or revisions of, any of these publications apply to this European Standard
only when incorporated in it by amendment or revision. For undated references the latest edition of the publication
referred to applies (including amendments).
EN 540, Clinical investigation of medical devices for human subjects.
EN 980, Graphical symbols for use in the labelling of medical devices.
EN 1441, Medical devices – Risk analysis.
EN ISO 10993-1, Biological evaluation of medical devices – Part 1: Evaluation and testing (ISO 10993-1 : 1997).
EN ISO 14630 : 1997, Non-active surgical implants – General requirements (ISO 14630 : 1997).
European Pharmacopoeia.
3 Terms and definitions
For the purposes of this standard, the following terms and definitions apply:
3.1
intra-uterine contraceptive device

IUD
copper-bearing device placed in the uterine cavity for the purpose of preventing pregnancy
3.2
insertion instrument
instrument designed to place an IUD in the uterine cavity
3.3
thread
attachment to an IUD for the purpose of verifying the presence of and enabling the removal of the IUD
NOTE The thread is intended to lie in the cervical canal and the vagina when the body of the device is placed correctly in the uterine
cavity.
3.4
visco-elastic property
property of an IUD enabling an approximate return to their initial configuration after deformation
3.5
active surface area
surface area of copper in the IUD that is intended to come into contact with uterine fluids
4

---------------------- Page: 6 ----------------------

SIST EN ISO 7439:2002
EN ISO 7439:2002 (E)
4 Intended performance
4.1 General
The requirements of clause 4 of EN ISO 14630:1997 shall apply.
4.2 Clinical performance
For physical requirements see clause 5.
An IUD shall meet the following requirements for a period of 3 years (the minimum intended lifetime of use):
– pregnancy rate  2 per 100 woman years during the 1st year as calculated by life-table analysis;


– expulsion rate < 10 per 100 woman years during the 1st year as calculated by life-table analysis.
5 Design attributes
5.1 General
The requirements of clause 5 of EN ISO 14630:1997 shall apply.
Thread and copper shall be integral parts of the IUD.
5.2 Shape
When tested by visual and tactile inspection an IUD shall have a form fitting the uterine cavity and designed in such a
way as to minimize the risk of perforation and subsequent bowel obstruction. The IUDs and insertion instruments shall
not exhibit sharp edges.
The design of the IUD shall be such that no excessive forces are required for insertion and removal.
5.3 Dimensions
5.3.1 IUD
The nominal length of an IUD shall not be greater than 36 mm, the nominal width of an IUD shall not be greater than
32 mm.
When determined as specified in 7.2.1, the dimensions shall be consistent with the specifications as given by the
manufacturer within tolerances of ± 5 %.
5.3.2 Copper components
2 2
The nominal active surface area of copper shall be at least 200 mm , but shall not be larger than 380 mm . If copper
wire is used, the nominal diameter of the copper wire shall be at least 0,25 mm.
The diameter shall be consistent with the specifications as given by the manufacturer within tolerances of ± 5 % and
the active surface area within tolerances of ± 10 %.
5.3.3 Thread
When determined in accordance with 7.2.2 the length of the thread shall be not less than 100 mm.
5

---------------------- Page: 7 ----------------------

SIST EN ISO 7439:2002
EN ISO 7439:2002 (E)
5.3.4 Insertion instrument
The maximum nominal outer width of the part of an insertion instrument intended to come into contact with the cervical
canal shall not be greater than 5 mm.
The dimensions shall be consistent with the specifications as given by the manufacturer within tolerances of ± 5 %.
5.4 Tensile force
When tested in accordance with 7.3 the IUD, including the thread, shall withstand a tensile force of at least 12 N.
5.5 Stability
5.5.1 Shelf-life stability
The IUD shall meet any performance specification given by the manufacturer for the complete duration of the declared
shelf-life.
5.5.2 In situ stability
During its intended period of use the copper components shall retain structural integrity and the entire IUD shall
withstand the tensile force according to 5.4.
5.6 Visco-elastic property
When tested in accordance with 7.4 the recovery of any part of the IUD from its original design position shall be such
that the residual deformation does not exceed 5 mm.
5.7 In situ detection
All parts of the IUD frame shall be detectable by X-ray examinations. If barium sulphate is used in the plastics
components as the opaque material its content shall range from 15 % (w/w) to 25 % (w/w), when tested as specified in
7.5.
6 Materials
The requirements of clause 6 of EN ISO 14630:1997 shall apply.
The plastics body including the substance conferring radio-opacity shall be visco-elastic, biocompatible and
non-absorbable.
The thread shall be monofilament, biocompatible and non-absorbable.
The purity of the copper shall be at le
...