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
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

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 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

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.
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 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

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.
INTERNATIONAL STANDARD ISO 4074:2015(E)
Natural rubber latex male condoms — Requirements and
test methods
1 Scope
This International Standard specifies requirements and test methods for male condoms made from
natural rubber latex.
2 Normative references
The following documents, in whole or in part, are normatively referenced in this document and are
indispensable for its application. For dated references, only the edition cited applies. For undated
references, the latest edition of the referenced document (including any amendments) applies.
ISO 2859-1, Sampling procedures for inspection by attributes — Part 1: Sampling schemes indexed by
acceptance quality limit (AQL) for lot-by-lot inspection
ISO 10993-1, Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk
management process
ISO 10993-5, Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity
ISO 10993-10, Biological evaluation of medical devices — Part 10: Tests for irritation and skin sensitization
ISO 15223-1, Medical devices — Symbols to be used with medical device labels, labelling and information to
be supplied — Part 1: General requirements
ISO 15223-2, Medical devices — Symbols to be used with medical device labels, labelling, and information
to be supplied — Part 2: Symbol development, selection and validation
ISO/IEC 17025, General requirements for the competence of testing and calibration laboratories
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 2859-1 and the following apply.
3.1
acceptance quality limit
AQL
quality level that is the worst tolerable process average when a continuing series of lots is submitted for
acceptance sampling
[SOURCE: ISO 2859-1:1999, 3.1.26]
3.2
male condom
medical device used by consumers, which is intended to cover and be retained on the penis during
sexual activity, for purposes of contraception and prevention of sexually transmitted infections
3.3
consumer package
package, intended for distribution to a consumer, containing one or more individual containers of condoms
ISO 4074:2015(E)
3.4
expiry date
date after which the condom should not be used
3.5
identification number
number, or combination of numerals, symbols, or letters, used by a manufacturer on consumer packages
to identify uniquely the lot numbers of individual condoms contained in that package, and from which it
is possible to trace those lots through all stages of manufacturing, packaging, and distribution
Note 1 to entry: When the consumer package contains only one type of condom, then the identification number may
be the same as the lot number; but if the consumer package contains several different types of condoms, for instance
condoms of different shapes or colours, then the identification number will be different from the lot numbers.
3.6
individual container
primary package containing a single condom
3.7
inspection level
index of the relative amount of inspection of an acceptance sampling scheme, chosen in advance, and
relating the sample size to the lot size
[SOURCE: ISO 3534-2:2006, 4.3.5]
3.8
lot
collection of condoms of the same design, colour, shape, size, and formulation, manufactured at
essentially the same time, using the same process, raw materials of the same specifications, common
equipment, and packed with the same lubricant and any other additive or dressing in the same type of
individual container
3.9
lot number
number, or combination of numerals, symbols, or letters, used by the manufacturer to identify a lot
of individually packaged condoms, and from which it is possible to trace that lot through all stages of
manufacture up to packaging
3.10
non-visible hole
hole in a condom that is not visible under normal or corrected vision but is detected by the water leak
test or the electrical test described in this International Standard
3.11
sampling plan
specific plan which indicates the number of units of product from each lot which are to be inspected
(sample size or series of sample sizes) and the associated criteria for determining the acceptability of
the lot (acceptance and rejection numbers)
3.12
shelf life
period from date of manufacture during which condoms are required to conform to the requirements
for bursting pressure, bursting volume, freedom from holes, and pack integrity specified in this
International Standard
3.13
visible hole
hole in the condom that is visible under normal or corrected vision before the condom is filled with
water or electrolyte during testing for freedom from holes
2 © ISO 2015 – All rights reserved

ISO 4074:2015(E)
3.14
date of manufacture
date specified by the manufacturer when the product was made subject to the requirements
specified in 11.1
3.15
visible defects (other than holes and tears)
broken, missing, or severely distorted bead and permanent creases with adhesion of the film
4 Quality verification
Condoms are mass produced articles manufactured in very large quantities. Inevitably, there will be
some variation between individual condoms, and a small proportion of condoms in each production
run might not meet the requirements in this International Standard. Further, the majority of the test
methods described in this International Standard are destructive. For these reasons the only practicable
method of assessing conformity with this International Standard is by testing a representative sample
from a lot or series of lots. Basic sampling plans are given in ISO 2859-1. Reference should be made
[2]
to ISO/TR 8550 for guidance on the use of acceptance sampling system, scheme, or plan for the
inspection of discrete items in lots. For testing purposes, sampling shall be conducted by lot number,
not by identification number.
When on-going verification is required of the quality of condoms, it is suggested that, instead of
concentrating solely on evaluation of the final product, attention is also directed at the manufacturer’s
[4]
quality system. In this connection, it should be noted that ISO 13485 covers the provision of an
integrated quality system for the manufacture of medical devices.
Sampling plans shall be selected to provide an acceptable level of consumer protection. Suitable
sampling plans are given in Annexes A and B.
a) Annex A describes sampling plans based on ISO 2859-1 and is most applicable to manufacturers
or purchasers assessing the conformity of a continuing series of lots. The full level of consumer
protection available depends upon the switch to tightened inspection if deterioration in quality
is detected. The switching rules, described in ISO 2859-1:1999, Clause 9, cannot offer their full
protection for the first two lots tested but become progressively more effective as the number of
lots in a series increases. The sampling plans in Annex A are recommended when five or more lots
are being tested.
b) Annex B describes sampling plans, based on ISO 2859-1, that are recommended for the assessment
of isolated lots. The sampling plans in Annex B provide approximately the same level of consumer
protection as those given in Annex A when used with the switching rules. It is recommended that
these sampling plans are used for the assessment of fewer than five lots, for example in cases
of dispute, for referee purposes, for type testing, for qualification purposes, or for short runs of
continuing lots.
It is necessary to know the lot size in order to derive from ISO 2859-1 the number of condoms to be
tested. The lot size will vary between manufacturers and is regarded as part of the process and quality
controls used by the manufacturer.
If the lot size is not known or cannot be confirmed by the manufacturer, then a lot size of 500 000
condoms shall be assumed for determining the sample sizes for testing.
5 Lot size
The maximum individual lot size for production shall be 500 000 condoms.
NOTE This International Standard does not specify the size of a lot, but it is possible for a purchaser to
do so as part of the purchasing contract. Purchasers are encouraged to specify a lot size compatible with the
manufacturer’s quality management system.
ISO 4074:2015(E)
6 Biocompatibility
For any new product or following a significant change to the formulation or manufacturing process,
biocompatibility assessments shall be conducted in accordance with ISO 10993-1. Evaluation for
cytotoxicity according to ISO 10993-5, irritation according to ISO 10993-10, and sensitization (delayed
contact hypersensitivity) according to ISO 10993-10 shall be conducted. The condom together with any
lubricant, additive, dressing material, or powder applied to it shall be evaluated.
The laboratory used for any testing shall comply with the requirements contained in ISO/IEC 17025.
The results shall be interpreted by a qualified toxicologist or any other appropriately qualified expert.
The biological assessment report shall justify that the product is safe for its intended use.
NOTE Many latex products that have been established as safe including condoms and medical gloves can
exhibit a positive cytotoxic response when tested according to ISO 10993-5. While any cytotoxic effect can
be of concern, it is primarily an indication of potential for in vivo toxicity and a condom cannot necessarily be
determined to be unsuitable for use based solely on cytotoxicity data.
7 Microbial contamination
Manufacturers are recommended to establish procedures for the control and periodic monitoring
of microbial contamination (bioburden) as part of their quality management system. Staphylococcus
aureus, Pseudomonas aeruginosa, and Enterobacteriaceae, including Escherichia coli, are pathogenic
organisms that can potentially be found on condoms and can cause urinary tract or other infections.
It is recommended that these organisms are absent from condoms. The procedures should include
requirements for 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.
NOTE 1 General methods for determining microbial contamination on sterile medical devices are given in
[3]
ISO 11737-1. It includes methods for validating testing (ISO 11737-1:2006, Annex C). The methods described in
Annex G of this International Standard have been found to be suitable for use with condoms taking into account
specific issues associated with testing these products. These issues include the residual antimicrobial activity of
some of compounds used in latex formulations which can interfere with the assays.
NOTE 2 To control microbial contamination on the finished product, manufacturers need to control the
manufacturing environment to reduce the risk of contaminating the product, establish general cleaning and
sanitizing procedures throughout the operation, and monitor bioburden levels on raw materials and equipment.
8 Product claims
Condoms meeting the requirements of this International Standard may be used for contraceptive
purposes and to help protect against sexually transmitted infections. Manufacturers shall justify any
additional claims made for their products. If a manufacturer makes a claim relating to improved efficacy
or safety, then the claim shall be substantiated by appropriate clinical investigation to demonstrate
superiority. Information supporting such claims shall be made available on request to interested parties
including regulatory authorities and notified bodies.
9 Design
9.1 Integral bead
The open end of the condom shall terminate in an integral bead.
9.2 Lubrication
If verification is required of the quantity of lubricant on a condom (and in the package), either of, the
methods given in Annex C shall be used. The criteria of compliance shall be as agreed between the
parties concerned.
4 © ISO 2015 – All rights reserved

ISO 4074:2015(E)
The methods in Annex C also recover part of the dressing powder on the condom. An allowance should
be made for this when manufacturers or purchasers specify lubricant levels.
9.3 Dimensions
9.3.1 Length
When tested by the method given in Annex D, taking 13 condoms from each lot, no individual
measurement shall be below 160 mm.
Condoms that do not comply with the limit specified above cannot be claimed to meet ISO 4074.
9.3.2 Width
When tested by the method given in Annex E, measuring at the narrowest part of the condom in the
range of 20 mm to 50 mm from the open end, taking 13 condoms from each lot, no measurement of the
width shall deviate from the nominal width stated by the manufacturer by more than ±2 mm.
9.3.3 Thickness
If verification is required of the thickness of a condom, the average thickness, determined in
accordance with one of the methods given in Annex F, shall be equal to the claimed nominal thickness,
subject to a tolerance of
— ±0,008 mm for condoms with nominal claimed thickness less than 0,05 mm;
— ±0,01 mm for condoms with nominal claimed thickness equal to or greater than 0,05 mm.
10 Bursting volume and pressure
When determined in accordance with Annex H, the bursting pressure shall not be less than 1,0 kPa and
the bursting volume shall be not less than the following:
— 16,0 dm for condoms with a mid-body width greater than or equal to 45,0 mm and less than
50,0 mm; or
— 18,0 dm for condoms with a mid-body width greater than or equal to 50,0 mm and less than
56,0 mm; or
— 22,0 dm for condoms with a mid-body width greater than or equal to 56,0 mm and less than
65,0 mm; or
— 28,0 dm for condoms with a mid-body width greater than or equal to 65,0 mm and not more
than 75,0 mm.
For the purpose of this test, the mid-body width is the mean flat width rounded to the nearest 0,5 mm of
13 condoms measured in accordance with Annex E at a point (75 ± 5) mm from the closed end excluding
the reservoir tip.
The compliance level for each lot shall be an AQL of 1,5 for condoms that fail the requirement for
bursting volume or bursting pressure or both.
Condoms that do not comply with the limits specified above cannot be claimed to meet ISO 4074.
For condoms that have a mid-body width less than 45,0 mm and/or are shorter than 160 mm excluding
the reservoir tip, guidelines for bursting pressures and volumes are given in Annex P. Marketing of
these products is at the discretion of the appropriate regulatory authorities or notified bodies.
ISO 4074:2015(E)
11 Stability and shelf life
11.1 General
Manufacturers shall verify that the condoms comply with the
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