SIST EN ISO 4074:2016

SLOVENSKI STANDARD
SIST EN ISO 4074:2016
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
SIST EN ISO 4074:2016 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 4074:2016

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SIST EN ISO 4074:2016


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.

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SIST EN ISO 4074:2016
EN ISO 4074:2015 (E)
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

2

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SIST EN ISO 4074:2016
EN ISO 4074:2015 (E)
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.
3

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SIST EN ISO 4074:2016
EN ISO 4074:2015 (E)
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.
4

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SIST EN ISO 4074:2016
EN ISO 4074:2015 (E)
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
5

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SIST EN ISO 4074:2016
EN ISO 4074:2015 (E)
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.
6

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SIST EN ISO 4074:2016
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

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SIST EN ISO 4074:2016
ISO 4074:2015(E)

COPYRIGHT PROTECTED DOCUMENT
© ISO 2015, Published in Switzerland
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form
or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior
written permission. Permission can be requested from either ISO at the address below or ISO’s member body in the country of
the requester.
ISO copyright office
Ch. de Blandonnet 8 • CP 401
CH-1214 Vernier, Geneva, Switzerland
Tel. +41 22 749 01 11
Fax +41 22 749 09 47
copyright@iso.org
www.iso.org
ii © ISO 2015 – All rights reserved

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SIST EN ISO 4074:2016
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 . 7
11.4 Estimating shelf life based upon accelerated stability studies . 7
12 Freedom from holes . 7
13 Visible defects. 8
14 Package integrity of individual container . 8
15 Packaging and labelling . 8
15.1 Packaging . 8
15.2 Labelling . 8
15.2.1 General. 8
15.2.2 Symbols . 8
15.2.3 Individual container . . 8
15.2.4 Consumer package . 9
15.2.5 Condoms not distributed in consumer packages .11
15.3 Inspection .11
16 Test report .11
Annex A (normative) Sampling plans intended for assessing compliance of a continuing
series of lots of sufficient number to allow the switching rules to be applied .12
Annex B (informative) Sampling plans intended for assessing compliance of isolated lots .14
Annex C (normative) Determination of total lubricant for condoms in individual containers .16
Annex D (normative) Determination of length .20
Annex E (normative) Determination of width .22
Annex F (normative) Determination of thickness .23
Annex G (informative) Determination of microbial contamination .26
© ISO 2015 – All rights reserved iii

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SIST EN ISO 4074:2016
ISO 4074:2015(E)

Annex H (normative) Determination of bursting volume and pressure .31
Annex I (normative) Oven treatment for condoms .33
Annex J (informative) Determination of force and elongation at break of test pieces of condoms .34
Annex K (normative) Determination of shelf life by real-time stability studies .37
Annex L (informative) Guidance on conducting and analysing accelerated ageing studies .40
Annex M (normative) Testing for holes .42
Annex N (normative) Testing for package integrity .48
Annex O (informative) Calibration of air inflation equipment for determination of bursting
volume and pressure .50
Annex P (informative) Recommendations for testing condoms that fall outside of the size
ranges specified in ISO 4074 .54
Bibliography .56
iv © ISO 2015 – All rights reserved

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SIST EN ISO 4074:2016
ISO 4074:2015(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.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www.iso.org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation on the meaning of ISO specific terms and expressions related to conformity
assessment, as well as information about ISO’s adherence to the WTO principles in the Technical
Barriers to Trade (TBT) see the following URL: Foreword - Supplementary information
The committee responsible for this document is ISO/TC 157, Non-systemic contraceptives and STI barrier
prophylactics.
This third edition cancels and replaces the second edition (ISO 4074:2014), which has been technically
revised. The modifications are as follows:
a) The maximum lot size has been limited to 500 000.
b) Specific requirements for biocompatibility assessments, as defined in ISO 10993-1, have been added.
c) It is recommended that manufacturers establish procedures for the periodic monitoring of microbial
contamination (bioburden) as part of their quality management system including requirements for
the absence of specific pathogens and limits for total viable counts on finished condoms; methods
of determining bioburden levels on condoms are given in Annex G.
d) Specific requirements for extra strength condoms have been deleted but there is now a general
requirement for manufacturers to justify any additional claims made for their products; claims
relating to improved efficacy or safety have to be substantiated by clinical investigation.
3
e) A minimum airburst volume of 28,0 dm has been introduced for condoms with mid-body widths
that are greater than or equal to 65,0 mm and not more than 75,0 mm.
f) The radius of the inner edge of the clamping collar wherever it contacts the inflated condom has to
be a minimum of 2 mm (Annex H).
g) The volumes of electrolyte used in the electrical test for determining freedom from holes described
in Annex M have been brought into line with the volumes used for the water leak test.
h) The volumes of water or electrolyte specified in the freedom from holes test have been increased for
condoms that have mid-body widths greater than or equal to 56 mm and/or are longer that 210 mm.
i) When conducting the electrical test for freedom from holes, the voltage is now measured from the
time that the condom is first immersed and for up to 10 s after full immersion.
© ISO 2015 – All rights reserved v

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SIST EN ISO 4074:2016
ISO 4074:2015(E)

[8]
j) The method of testing for freedom from holes specified in ASTM D3492 has been included by
reference.
k) A limit has been introduced for the number of individual containers with visibly open seals, to
be evaluated when the containers are inspected during the freedom from holes test described in
Annex M.
l) Recommended requirements for minimum airburst properties and freedom from holes testing for
condoms narrower than 45 mm and/or shorter than 160 mm have been introduced in informative
Annex P to provide guidance to regulatory authorities, notified bodies and other interested
parties when assessing condoms that fall outside of the normative size range specified in this
International Standard.
m) Amendments have been made to the methods for determining the shelf life of condoms including a
simplified procedure for determining the shelf life by accelerated stability studies based on fixed
ageing periods at 50 °C.
n) Testing for freedom from holes, airburst properties, and package integrity are required when
conducting stability studies to establish that condoms meet the minimum stability requirements
specified in this International Standard and when determining condom shelf lives.
o) The procedure for determining the thickness of a condom by the micrometer method is
described in detail.
p) An alternative method of removing the lubricant from the condom using an aqueous surfactant
solution has been introduced into the method for determining the amount of lubricant on the condom.
q) Revisions have been made to labelling requirements including the additional information supplied
with the condom.
Regulatory agencies, notified bodies, and purchasers should consider the need for a transition period
when implementing the requirements of this International Standard to allow manufacturers to make
the changes required to maintain compliance. This applies particularly to the changes in packaging and
labelling specified in Clause 15.
vi © ISO 2015 – All rights reserved

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SIST EN ISO 4074:2016
ISO 4074:2015(E)

Introduction
Condoms made from intact latex film have 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. Numerous clinical studies have confirmed that male latex condoms are effective in
helping to prevent pregnancy and reduce the risk of transmission of most STIs including HIV.
In order to help ensure that condoms are effective for contraceptive purposes and in 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.
Condoms are medical devices. To ensure high quality product, it is essential that condoms are produced
[4]
under a good quality management system. See ISO 13485 for quality management requirements and
[5]
ISO 14971 for risk management requirements.
Condoms are non-sterile medical devices but manufacturers are advised to take appropriate
precautions to minimize microbiological contamination of the product throughout the manufacturing
and packaging processes. Recommendations for manufacturers to periodically monitor microbial
contamination during production are included in this International Standard. Methods that can be used
to determine bioburden levels are included in Annex G.
This International Standard requires manufacturers to conduct stability tests to estimate the shelf
life of any new or modified condom before the product is placed on the market and to initiate real-
time stability studies. These requirements are described in Clause 11. The real-time stability test can
be considered as part of the manufacturers’ requirement to conduct post-marketing surveillance on
their products. These requirements are intended to ensure that manufacturers have adequate data to
support shelf life claims before products are placed on the market and that these data are available for
review by regulatory authorities, third party test laboratories, and purchasers. They are also intended
to limit the need for third parties to conduct long-term stability studies.
Condoms might be subject to specific local requirements as required by national regulatory bodies in
addition to those specified in this International Standard.
[6]
ISO 16038 provides guidance for the application of this International Standard. It includes additional
information on the test methods and requirements specified in this International Standard.
© ISO 2015 – All rights reserved vii

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SIST EN ISO 4074:2016

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SIST EN ISO 4074:2016
INTERNATIONAL STANDARD ISO 4074:2015(E)
Natural rubber latex male condoms —
...