EN ISO 4074:2002
(Main)Natural latex rubber condoms - Requirements and test methods (ISO 4074:2002)
Natural latex rubber condoms - Requirements and test methods (ISO 4074:2002)
To align EN and ISO standards for natural rubber latex male condoms
Kondome aus Naturkautschuklatex - Anforderungen und Prüfverfahren (ISO 4074:2002)
Diese Norm legt die Mindestanforderungen und Prüfverfahren für aus Naturkautschuklatex hergestellte Kondome fest, die zur Empfängnisverhütung und zur Unterstützung des Schutzes vor sexuell übertragbaren Infektionen an Verbraucher geliefert werden.
Préservatifs masculins en latex de caoutchouc naturel - Exigences et méthodes d'essai (ISO 4074:2002)
Kondomi iz naravnega kavčuka - Zahteve in preskusne metode (ISO 4074:2002)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-november-2002
1DGRPHãþD
SIST EN 600:2000
.RQGRPLL]QDUDYQHJDNDYþXND=DKWHYHLQSUHVNXVQHPHWRGH ,62
Natural latex rubber condoms - Requirements and test methods (ISO 4074:2002)
Kondome aus Naturkautschuklatex - Anforderungen und Prüfverfahren (ISO 4074:2002)
Préservatifs masculins en latex de caoutchouc naturel - Exigences et méthodes d'essai
(ISO 4074:2002)
Ta slovenski standard je istoveten z: EN ISO 4074:2002
ICS:
11.200 1DþUWRYDQMHGUXåLQH Birth control. Mechanical
0HKDQVNLNRQWUDFHSFLMVNL contraceptives
SULSRPRþNL
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EUROPEAN STANDARD
EN ISO 4074
NORME EUROPÉENNE
EUROPÄISCHE NORM
February 2002
ICS 11.200 Supersedes EN 600:1996
English version
Natural latex rubber condoms - Requirements and test methods
(ISO 4074:2002)
Préservatifs masculins en latex de caoutchouc naturel - Kondome aus Naturkautschuklatex - Anforderungen und
Exigences et méthodes d'essai (ISO 4074:2002) Prüfverfahren (ISO 4074:2002)
This European Standard was approved by CEN on 2 February 2002.
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 4074:2002 E
worldwide for CEN national Members.
CORRECTED 2002-04-17
Foreword
This document (ISO 4074:2002) has been prepared by Technical Committee ISO/TC 157
"Mechanical contraceptives" in collaboration with Technical Committee CEN/TC 205 "Non-active
medical devices", the secretariat of which is held by BSI.
This document supersedes EN 600:1996.
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
standard.
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 August 2002, and conflicting national standards shall
be withdrawn at the latest by August 2002.
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.
Endorsement notice
The text of the International Standard ISO 4074:2002 has been approved by CEN as a European
Standard without any modifications.
Annex ZA
(informative)
Clauses of this European Standard addressing essential requirements or
other provisions of EU Directives
This European Standard 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 93/42/EEC.
WARNING: Other requirements and other EU Directives may be applicable to the product(s)
falling within the scope of this standard.
The following clauses of this standard are likely to support requirements of Directive 93/42/EEC.
Compliance with these clauses of this standard provides one means of conforming with the specific
essential requirements of the Directive concerned and associated EFTA regulations.
Table ZA.1 - Correspondence between this European Standard and EU Directives
Clause/subclause of this Corresponding Essential Comments
European Standard Requirement of Directive
93/42/EEC
4 (Quality verification) 1, 6
5 (Design) 1, 2, 3, 4, 5
6 (Burst) 3, 4, 5, 7.3
6.3 (Extra strength) 3
7 (Stability and shelf life) 4, 5
8 (Holes) 3, 4, 5, 7.5, 7.6
9 (Visible defects) 3, 4
10 (Package Integrity) 3, 5, 7.2, 8.1
11.1 (Packaging) 5, 7.2, 7.3, 7.5, 7.6, 8.1
11.2 (Labelling) 13.1, 13.2, 13.3 a), b), d), e), f), i), j),
k), 13.4, 13.6 a), d), l), n), o)
11.3 (Inspection) 3, 4, 5
Annexes, verifying of
requirements, not included as
they have the requirements in
the text above.
INTERNATIONAL ISO
STANDARD 4074
First edition
2002-02-15
Corrected version
2002-12-01
Natural latex rubber condoms —
Requirements and test methods
Préservatifs masculins en latex de caoutchouc naturel — Exigences et
méthodes d'essai
Reference number
ISO 4074:2002(E)
ISO 4074:2002(E)
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©
ii ISO 2002 – All rights reserved
ISO 4074:2002(E)
Contents Page
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Quality verification . 3
5 Design . 3
6 Burst volume and pressure . 4
7 Tests for stability and shelf life . 5
8 Freedom from holes . 6
9 Visible defects . 6
10 Package integrity . 6
11 Packaging and labelling . 7
12 Test report . 9
Annexes
A Sampling plans intended for assessing compliance of a continuing series
of lots of sufficient number to allow the switching rules to be applied. 10
B Sampling plans intended for assessing compliance of isolated lots . 11
C Determination of total lubricant for condoms in individual containers. 12
D Determination of length. 14
E Determination of width . 16
F Determination of thickness . 17
G Determination of bursting volume and pressure . 19
H Oven treatment for condoms. 22
I Determination of force and elongation at break of test pieces of condoms. 23
J Determination of shelf life by real-time stability studies. 25
K Guidance on conducting and analysing accelerated ageing studies . 27
L Testing for holes. 30
M Tests for package integrity . 35
N Test report. 37
O Calibration of air inflation equipment for determination of burst volume
and pressure . 38
P Rationale. 41
Bibliography. 45
©
ISO 2002 – All rights reserved iii
ISO 4074:2002(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO
member bodies). The work of preparing International Standards is normally carried out through ISO technical
committees. Each member body interested in a subject for which a technical committee has been established has
the right to be represented on that committee. International organizations, governmental and non-governmental, in
liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical
Commission (IEC) on all matters of electrotechnical standardization.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 3.
Draft International Standards adopted by the technical committees are circulated to the member bodies for voting.
Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote.
Attention is drawn to the possibility that some of the elements of this International Standard may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights.
International Standard ISO 4074 was prepared by Technical Committee ISO/TC 157, Mechanical contraceptives.
This first edition of ISO4074 cancels and replaces ISO4074-1:1996, ISO4074-2:1994, ISO4074-3:1994,
ISO4074-4:1980, ISO4074-5:1996, ISO4074-6:1996, ISO4074-7:1996, ISO4074-8:1984, ISO4074-9:1996,
ISO 4074-10:1990 and ISO 4074-12:1980.
Annexes A, C, D, E, F, G, H, I, J, L, M and N form a normative part of this International Standard. Annexes B, K, O
and P are for information only.
This corrected version of ISO 4074:2002 incorporates correction in the Foreword, where the years of publication of
the parts of ISO 4074 being replaced by the new edition were erroneously omitted.
©
iv ISO 2002 – All rights reserved
ISO 4074:2002(E)
Introduction
The intact latex film has been shown to be a barrier to human immunodeficiency virus (HIV), other infectious agents
responsible for the transmission of sexually transmitted infections (STIs) and to spermatozoa. In order to help ensure
that condoms are effective for contraceptive purposes and for assisting in the prevention of transmission of STIs, it is
essential that condoms fit the penis properly, are free from holes, have adequate physical strength so as not to break
during use, are correctly packaged to protect them during storage and are correctly labelled to facilitate their use. All
these issues are addressed in this International Standard.
The condom and any lubricant, additive, dressing, individual packaging material or powder applied to it should
neither contain nor liberate substances in amounts that are tox
...
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