EN ISO 4074:2015

SLOVENSKI STANDARD
01-januar-2016
1DGRPHãþD
SIST EN ISO 4074:2002
SIST EN ISO 4074:2002/AC:2004
SIST EN ISO 4074:2002/AC:2008
.RQGRPLL]QDUDYQHJDNDYþXND=DKWHYHLQSUHVNXVQHPHWRGH,62
Natural rubber latex male condoms - Requirements and test methods (ISO 4074:2015)
Kondome aus Naturkautschuklatex - Anforderungen und Prüfverfahren (ISO 4074:2015)
Préservatifs masculins en latex de caoutchouc naturel - Exigences et méthodes d'essai
(ISO 4074:2015)
Ta slovenski standard je istoveten z: EN ISO 4074:2015
ICS:
11.200 1DþUWRYDQMHGUXåLQH Birth control. Mechanical
0HKDQVNLNRQWUDFHSFLMVNL contraceptives
SULSRPRþNL
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN ISO 4074
EUROPEAN STANDARD
NORME EUROPÉENNE
November 2015
EUROPÄISCHE NORM
ICS 11.200 Supersedes EN ISO 4074:2002
English Version
Natural rubber latex male condoms - Requirements and
test methods (ISO 4074:2015)
Préservatifs masculins en latex de caoutchouc naturel - Kondome aus Naturkautschuklatex - Anforderungen
Exigences et méthodes d'essai (ISO 4074:2015) und Prüfverfahren (ISO 4074:2015)
This European Standard was approved by CEN on 16 July 2015.

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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2015 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 4074:2015 E
worldwide for CEN national Members.

Contents Page
European foreword . 3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC on Medical Devices . 5

European foreword
This document (EN ISO 4074:2015) has been prepared by Technical Committee ISO/TC 157 "Non-
systemic contraceptives and STI barrier prophylactics" in collaboration with Technical Committee
CEN/TC 205 “Non-active medical devices” 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 May 2016, and conflicting national standards shall be
withdrawn at the latest by November 2017.
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 4074:2002.
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 EU Directive(s).
For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this
document.
The following referenced documents are indispensable for the application of this document. For
undated references, the latest edition of the referenced document (including any amendments) applies.
For dated references, only the edition cited applies. However, for any use of this standard ‘within the
meaning of Annex ZA’, the user should always check that any referenced document has not been
superseded and that its relevant contents can still be considered the generally acknowledged state-of-
art.
When an IEC or ISO standard is referred to in the ISO standard text, this shall be understood as a
normative reference to the corresponding EN standard, if available, and otherwise to the dated version
of the ISO or IEC standard, as listed below.
NOTE The way in which these referenced documents are cited in normative requirements
determines the extent (in whole or in part) to which they apply.
Table 1 — Correlation between normative references and dated EN and ISO or IEC standards
Normative references Equivalent dated standard
as listed in Clause 2 of the ISO
EN ISO or IEC
standard
ISO 2859-1 --- ISO 2859-1:1999 + Cor1:2001
ISO 10993-1 EN ISO 10993-1:2009 ISO 10993-1:2009
ISO 10993-5 EN ISO 10993-5:2009 ISO 10993-5:2009
ISO 10993-10 EN ISO 10993-1:2013 ISO 10993-1:2010
ISO 15223-1 EN ISO 15223-1:2012 ISO 15223-1:2012
ISO 15223-2 --- ISO 15223-2:2010
ISO/IEC 17025 EN ISO/IEC 17025:2005 ISO/IEC 17025:2005

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, Former Yugoslav Republic of Macedonia,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta,
Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.
Endorsement notice
The text of ISO 4074:2015 has been approved by CEN as EN ISO 4074:2015 without any modification.
Annex ZA
(informative)
Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC on Medical Devices
This European Standard has been prepared under a mandate given to CEN by the European
Commission and the European Free Trade Association to provide one means of conforming to Essential
Requirements of the New Approach Medical Devices Directive 93/42/EEC.
Once this standard is cited in the Official Journal of the European Union under that Directive and has
been implemented as a national standard in at least one Member State, compliance with the normative
clauses of this standard given in Table ZA.1 confers, within the limits of the scope of this standard, a
presumption of conformity with the corresponding Essential Requirements of that Directive and
associated EFTA regulations.
Table ZA.1— Correspondence between this European Standard and the Essential Requirements
of EU Directive 93/42/EEC as amended for medical devices
Clause(s)/sub- Essential requirements Qualifying remarks/Notes
clause(s) of this (ERs) of EU Directive
93/42/EEC
European Standard
6, 7, 14, 15 7.2 Clauses 6, 7, 14 and 15 provide a presumption of
conformity with the Essential Requirements relating
to the risk posed by contaminants and residues to
persons involved in the transport, storage and use of
the devices.
6, 15.2.4.2 7.3 Clause 15.2.4.2 includes requirements for information
to users regarding use of additional lubricants with
condoms.
6, 15.2.4.2 7.4 This standard does not consider the systemic safety
and usefulness of any ancillary medicinal substance
that could be incorporated into the condom.
6 7.5
7 8.1 Condoms are not sterile devices but manufacturers
should take steps to control microbial contamination.
14, 15.1 8.6
15.2 13.1
15.2.2,15.2.4.1, 13.2
15.2.4.2,
15.2.3, 15.2.4.1, 13.3
15.2.4.2, 15.2.5
15.2.4.1, 15.2.4.2 13.4
15.2.3, 15.2.4.1 13.5
15.2.4.2, 15.2.5 13.6
Annexes, which
provide details of
test methods, have
not been included
as the all the
requirements are
included above.
WARNING — Other requirements and other EU Directives may be applicable to the products
falling within the scope of this European Standard.
INTERNATIONAL ISO
STANDARD 4074
Third edition
2015-10-15
Natural rubber latex male condoms —
Requirements and test methods
Préservatifs masculins en latex de caoutchouc naturel — Exigences et
méthodes d’essai
Reference number
ISO 4074:2015(E)
©
ISO 2015
ISO 4074:2015(E)
© ISO 2015, Published in Switzerland
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ii © ISO 2015 – All rights reserved

ISO 4074:2015(E)
Contents Page
Foreword .v
Introduction .vii
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Quality verification . 3
5 Lot size . 3
6 Biocompatibility . 4
7 Microbial contamination. 4
8 Product claims . 4
9 Design . 4
9.1 Integral bead . 4
9.2 Lubrication . 4
9.3 Dimensions . 5
9.3.1 Length. 5
9.3.2 Width . 5
9.3.3 Thickness . 5
10 Bursting volume and pressure . 5
11 Stability and shelf life . 6
11.1 General . 6
11.2 Minimum stability requirements . 6
11.3 Procedure for determining shelf life by real-time stability studies .
...