EN ISO 4074:2002

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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©
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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
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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.
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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 toxic, sensitizing, locally irritating or otherwise harmful
under normal conditions of storage or use. Reference should be made to ISO 10993 for test methods to evaluate the
safety of condoms particularly in respect of the risk of local irritation and sensitization.
Condoms are medical devices. Therefore they should be produced under a good quality management system.
Reference should be made, for example to the ISO 9000-series, ISO 14971-1 and one of the relevant standards:
ISO 13485 or ISO 13488.
Condoms are non-sterile medical devices but manufacturers should take appropriate precautions to minimize
microbiological contamination of the product during manufacture and packaging.
This first edition of ISO 4074 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 7. The real-time stability test can be considered as part of the manufacturer’s
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.
A guideline (ISO16038) for the application of this International Standard is under development by
ISO/TC 157/WG 14.
This International Standard contains requirements for tensile properties (force at break) when a manufacturer makes
a claim for “extra strength”. Annex I contains the test method for determination of force and elongation at break, as it
may be useful in the quality system of a manufacturer and in very special cases in a purchaser’s contract.
Background information including technical explanations relating to certain clauses of this International Standard is
given in annex P. Where this is relevant, the appropriate clause in annex P is referenced in the text.
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INTERNATIONAL STANDARD ISO 4074:2002(E)
Natural latex rubber condoms — Requirements and test methods
1 Scope
This International Standard specifies the minimum requirements and the test methods to be used for condoms made
from natural rubber latex which are supplied to consumers for contraceptive purposes and to assist in the prevention
of sexually transmitted infections.
2 Normative references
The following normative documents contain provisions which, through reference in this text, constitute provisions of
this International Standard. For dated references, subsequent amendments to, or revisions of, any of these
publications do not apply. However, parties to agreements based on this International Standard are encouraged to
investigate the possibility of applying the most recent editions of the normative documents indicated below. For
undated references, the latest edition of the normative document referred to applies. Members of ISO and IEC
maintain registers of currently valid International Standards.
ISO 188, Rubber, vulcanized or thermoplastic — Accelerated ageing and heat resistance tests
ISO 2859-1:1999, Sampling procedures for inspection by attributes — Part1: Sampling schemes indexed by
acceptance quality limit (AQL) for lot-by-lot inspection
ISO 15223, Medical devices — Symbols to be used with medical device labels, labelling and information to be
supplied
EN 980, Graphical symbols for use in the labelling of medical devices
3 Terms and definitions
For the purposes of this International Standard, the terms and definitions given in ISO 2859-1 and the following
apply.
3.1
acceptable quality limit
AQL
When a continuous series of lots is considered, the quality level which for the purposes of sampling inspection is the
limit of a satisfactory process mean (according to ISO 2859-1)
3.2
condom
medical device used by consumers, which is intended to be retained on the penis during sexual activity, for purposes
of contraception and prevention of sexually transmitted infections
NOTE If a consumer could responsibly consider a device to be a condom (due to its shape, packaging, etc.), it is considered a
condom for the purpose of this International Standard.
3.3
consumer package
package, intended for distribution to a consumer, containing one or more individual containers
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ISO 4074:2002(E)
3.4
expiry date
stated date after which a 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 packaging and distribution
NOTE When the consumer package contains only one kind of condom, then the identification number may be the same as the
lot number. But if the consumer package contains several different types of condom, for instance condoms of different shapes or
colours, then the identification number will be different from the lot number.
3.6
individual container
immediate wrapping of a single condom
3.7
inspection level
relationship between lot size and sample size.
NOTE For description, see ISO 2859-1:1999, 10.1.
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
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. Attention is drawn to the difficulties that can be associated with the distribution and control of very large lots.
The recommended maximum individual lot size for production is 500 000.
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
NOTE For testing purposes, sampling is conducted by lot number, not identification number. See requirements in clause 4.
3.10
lot test
test to assess the compliance of a lot
NOTE A lot test may be limited to include only those parameters which may change from lot to lot.
3.11
non-visible hole
hole in the condom that is not visible under normal or corrected vision but is detected by leakage when rolling on
absorbant paper
3.12
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)
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ISO 4074:2002(E)
3.13
shelf life
time from date of manufacture to the claimed expiry date
3.14
visible hole
hole or tear in the condom that is visible under normal or corrected vision
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 may 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 compliance 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 to ISO/TR 8550 for guidance on the selection of an acceptance
sampling system, scheme or plan for the inspection of discrete items in a lot.
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, the party concerned also directs his attention to the manufacturer's quality system.
In this connection it should be noted that the ISO 9000 series (see Bibliography) covers the provision of an integrated
quality system.
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 compliance of a continuing series of lots. The full level of consumer protection available depends
upon the switch to tightened inspection if a deterioration in quality is detected. The switching rules cannot offer
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 be 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.
c) Handling and storage conditions shall be documented before drawing the samples.
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.
5 Design
5.1 Integral bead
The open end of the condom shall terminate in an integral bead and shall comply with clause 9.
5.2 Lubrication
If the amount of lubricant in the package is specified, then this amount shall be determined by the method described
in annex C.
The method in annex C also recovers part of the dressing powder on the condom. (See rationale, in P.7.) An
allowance should be made for this when manufacturers or purchasers specify lubricant levels.
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ISO 4074:2002(E)
5.3 Dimensions
5.3.1 Length
When tested by the method given in annex D, taking 13 condoms from each lot, no individual length measurement
160 mm
shall be below .
5.3.2 Width
When tested by the method given in annex E, taking 13 condoms from each lot, no width measurement shall deviate
from the nominal width stated by the manufacturer by more than ±2mm.
The width shall be measured at the narrowest part of the condom within 35 mm from the open end, or at a point
specified by the manufacturer within the same area.
NOTE The width for determination of the requirements for burst volume as in 6.1 may be measured at the same time.
5.3.3 Thickness
If the thickness of the condom is specified, then it shall be determined by the method in annex F.
6 Burst volume and pressure
6.1 Untreated condoms
When tested in accordance with annex G, the bursting pressure shall be not less than 1,0 kPa and the bursting
volume (rounded to the nearest 0,5 dm ) shall be not less than:
— 16,0 dm for condoms with a width less than 50,0 mm, or
— 18,0 dm for condoms with a width greater than or equal to 50,0 mm and up to 56,0 mm, or
— 22,0 dm for condoms with a width greater than or equal to 56,0 mm
The width is defined as the mean flat width of 13 condoms measured in accordance with annex E at a point
(75± 5) mm from the closed end. (See rationale in annex P.)
The compliance level for each lot shall be an AQL of 1,5 for non-conforming condoms.
A non-conforming condom is defined as a condom that fails the requirement for volume, pressure, or both, or any
condom that exhibits any leakage.
6.2 Lot testing for oven-treated condoms
The purpose of this test is to check for major formulation or vulcanization errors. When oven-treated as described in
◦
annex H for (168± 2) h at (70± 2) C and tested according to annex G, the condoms shall meet the requirements
of 6.1. This test does not provide information about the shelf life of the product.
This test is applicable only to condoms that are less than one year old from the date of manufacture.
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ISO 4074:2002(E)
6.3 Extra strength
6.3.1 General
If a manufacturer makes a claim that a particular brand of condoms is stronger or implies that a particular brand of
condoms provides extra protection or safety in use because the condoms are stronger than regular condoms, then
the additional requirements for “Extra Strength” condoms defined in this section shall apply. (See annex P.)
6.3.2 Requirements for mechanical properties
When tested according to annex G, the minimum bursting pressure shall be not less than 2,0 kPa and the bursting
volume shall conform to the requirements of 6.1.
When tested according to annex I, the minimum mean force at break shall be 100 N based on the mean of
13 condoms selected at random from each lot of condoms.
6.3.3 Requirements for clinical data
Manufacturers shall substantiate the extra-strength claims with clinical data or prominently display on the pack the
statement given in 11.2.3.2.
The clinical data shall substantiate a statistically significant reduction in breakage rate for the extra strong condom
when compared in a random, double blind trial to a reference, marketed condom from normal production produced
by the same manufacturer. The reference condom shall comply with the requirements of ISO 4074 and shall exceed
0,060 mm single wall thickness at the mid body.
Useful references are ISO 14155 or EN 540 and ISO 16037 (in preparation).
7 Tests for stability and shelf life
7.1 General
Manufacturers shall verify that the condoms comply with the requirements of 6.1 of this International Standard until
the end of the labelled shelf life. Shelf-life claims shall not exceed five years (see annex P).
Data supporting the shelf-life claims made by the manufacturer shall be made available to the appropriate regulatory
authorities and direct purchasers upon request.
Before a new or modified condom design is placed on the market, the following requirements shall be met.
— The condom shall be tested for the minimum stability requirements as described in 7.2.
— A real-time study as described in 7.3 to determine shelf life shall have commenced.
— Pending completion of the real-time study, shelf life shall be estimated as described in 7.4.
NOTE 1 A modified condom design is one in which there have been significant changes to the formulation, manufacturing
process or individual sealed containers.
NOTE 2 Compliance with the requirements of 7.1 does not imply that the shelf life of the product has been determined.
◦
Shelf-life estimates (7.4) shall be based on a mean kinetic temperature of 30 C for all climatic conditions and may
be carried out on condoms from the same production lots as used for real-time determination of shelf life (7.3).
For existing designs on the market at the date of publication of this International Standard, real-time data in a form
consistent with annex J, and at temperatures consistent with local regulatory requirements prevailing at the time the
product was introduced, shall be acceptable, to verify the shelf-life claims.
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ISO 4074:2002(E)
7.2 Minimum stability requirements
Test three lots of condoms for compliance with ISO 4074, except 11.2 and 11.3, using the sampling plans given in
annex B.
Only lots meeting all of the requirements of ISO 4074, except 11.2 and 11.3, shall be used for this test.
Incubate samples in their individual sealed containers according to annex H, one set for (168± 5) h (1 week) at
◦ ◦
(70± 2) C and the other set for (90± 1) days at (50± 2) C. At the end of the incubation periods, withdraw the
condoms and test for airburst properties according to annex G and the requirements of 6.1.
The test report shall include the requirements of annexes G and N.
NOTE Data to verify compliance with 7.2 can be extracted from studies for estimates of shelf life (7.4).
7.3 Procedure for determining shelf life by real-time stability studies
After testing according to annex J the condoms shall meet the requirements in 6.1.
If the real-time data indicate a shorter shelf life than that claimed on the basis of accelerated ageing (7.4), the
manufacturer shall notify the relevant regulatory authorities and direct purchasers. The manufacturer shall change
the shelf-life claim for the product to one based upon the real-time study. In no case shall shelf life exceed five years.
For condoms placed on the market, real-time stability studies shall be completed for the full period of the shelf-life
claim.
7.4 Estimating shelf life based upon accelerated stability studies
Pending the completion of real-time studies, accelerated stability studies shall be used to estimate the shelf life.
At the date of publication, no single method of analysis was sufficiently validated or widely used to justify its
designation as a standard method. Several approaches to the analysis of accelerated-ageing data have been
explored. It is anticipated that as manufacturers and regulatory agencies accumulate real-time data, a consensus
method for the next revision of this International Standard will be developed. Meanwhile, the results of accelerated-
ageing data may be analysed by a number of methods or as stipulated by the manufacturer's regulatory authority.
Examples of methods for accelerated studies and data analysis are provided in annex K. Data generated from such
studies shall support the claim that the condoms fulfil the requirements in 6.1 for the duration of the labelled shelf life
◦
at .30 C
8 Freedom from holes
When tested by either method described in annex L, the compliance level for each lot, for the sum of condoms with
visible and non-visible holes and tears, shall be an AQL of 0,25.
9 Visible defects
For visible defects as described in annex L (L.2.3.3, L.3.3.4), the compliance level for each lot shall be an AQL of 0,4.
10 Package integrity
When requested by a customer or a regulatory body, the manufacturer or supplier shall provide information on
package integrity based upon the test method given in annex M. The compliance level for each lot shall be an AQL of
2,5.
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ISO 4074:2002(E)
11 Packaging and labelling
11.1 Packaging
Each condom shall be packed in an individual container. One or more individual containers may be packed in other
packaging such as a consumer package. The individual container, or consumer package or both, shall be opaque to
light. However packaged, the packaging shall protect the condom from light even if only the individual package is
provided to the consumer.
If a marking medium, such as ink, is used on a condom or on any part of a package directly in contact with a condom,
it shall not have any deleterious effect on the condom or be harmful to the user.
Individual containers and any other packaging shall protect the condom from damage during transport and storage.
Individual containers and any other packaging shall be designed in such a way that the pack can be opened without
damaging the condom. The design of the individual container should facilitate easy opening. (See rationale in
annex P.)
11.2 Labelling
11.2.1 Symbols
If symbols are used on packaging, information and marketing materials, the symbols shall meet the requirements in
ISO 15223 or EN 980.
11.2.2 Individual container
Each individual container shall bear at least the following information:
a) the identity of the manufacturer or distributor. (See rationale in annex P);
b) the manufacturer's identifying reference for traceability (e.g. the lot number);
c) the expiry date (year, month). The format of the year shall be in four digits; the format of the month shall be in
letters or two digits. (See rationale in annex P.)
11.2.3 Consumer package
11.2.3.1 General
The outside of the consumer package shall bear at least the following information in at least one of the official
language(s) of the country of destination or as stipulated differently by that country:
a) a description of the condom, including whether or not it has a reservoir. If the condom is coloured or textured this
shall be stated;
b) the number of condoms contained;
c) the nominal width of the condom;
d) the name or trade name and address of the manufacturer and/or distributor, depending on national and regional
requirements. (See rationale in annex P);
e) the expiry date (year and month). The format of the year shall be in four digits and the format of the month shall
be in letters or two digits. If a consumer package includes condoms from different lots, the earliest expiry date
shall apply to all condoms;
f) a statement to store the condom in a cool dry place away from direct sunlight;
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ISO 4074:2002(E)
g) a statement that individual containers, if not opaque to light, should not be stored outside the opaque consumer
package;
h) whether the condom is lubricated or dry. When a medicinal ingredient is added, it shall be identified and its
purpose indicated (e.g. spermicidal). If the condom or lubricant is fragranced or flavoured, this shall be stated;
i) the manufacturer's identifying reference for traceability (e.g. the identification number/lot number). If different
types of condoms, e.g. different colours, are packaged together in the same consumer package, the identification
number on the consumer package shall allow the manufacturer to identify uniquely the lot numbers of the
individual condoms contained in that package, so that it is possible to trace those lots through all stages of
manufacture up to packaging;
j) a statement that the condom is made of natural rubber latex.
11.2.3.2 Labelling of extra-strong condoms
A claim such as “extra strong” implies that the condoms have a lower level of breakage than a “regular” condom.
Such claims shall be supported by clinical investigations. (See 6.3.3.)
If the manufacturer wishes to use the claim “extra strong” pending the completion of a clinical study, the labelling shall
state:
“This extra-strong condom has not been shown to be safer in use than regular condoms.”
11.2.4 Additional information on the consumer package
The outside or the inside of the consumer package, or a leaflet contained within the consumer package, shall bear at
least the following information expressed in simple terms, and in at least one of the official language(s) of the country
of destination, if possible supplemented by pictorial representations of the major steps involved or as stipulated
differently by that country.
a) Instructions for use of the condom, including
1) the need to handle the condom carefully, including removal from the package so as to avoid damage to the
condom by fingernails, jewellery etc.;
2) how and when to put on the condom; mention should be made that the condom should be placed on the erect
penis before any contact occurs between the penis and the partner's body to assist in the prevention of
sexually transmitted infections and pregnancy;
3) the need to withdraw the penis soon after ejaculation, while holding the condom firmly in place at the base of
the penis;
4) the need, if an additional lubricant is desired, to use the correct type of lubricant which is recommended for
use with condoms and the need to avoid the use of oil-based lubricants such as petroleum jelly, baby oil,
body lotions, massage oils, butter, margarine etc. as these are deleterious to the integrity of the condom;
5) the need to consult a doctor or pharmacist about the compatibility of topical medicines that may come in
contact with the condom.
b) Instructions on how to dispose of the used condom.
c) A statement that the condom is for single use.
d) The number of this International Standard, i.e. ISO 4074. (See rationale in annex P.)
11.3 Inspection
From each lot, 13 consumer packages and 13 individual containers shall be inspected for compliance. All inspected
containers shall comply with the requirements.
Under certain conditions it may be permissible for the manufacturer/distributor to correct faults associated with
packaging and labelling requirements and resubmit the lot for further conformity testing. Examples include insertion
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ISO 4074:2002(E)
of missing instruction leaflets or re-packaging of individual containers into new complete consumer packages before
placing on the market.
If condoms from the same lot are packed into different consumer packages, then at least one consumer package of
each variant should be inspected. The number of packages inspected should not exceed 13 unless the number of
variants exceeds 13.
12 Test report
Test reports shall contain at least the information as described in annex N.
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ISO 2002 – All rights reserved 9

ISO 4074:2002(E)
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
A.1 Quality verification
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, the party concerned also directs his attention to the manufacturer's quality system.
In this connection it should be noted that the ISO 9000 series (see Bibliography) covers the provision of an integrated
quality system.
A.2 Sampling plans and compliance levels
If a party wishes to establish, by inspection and testing of samples of the final product, whether a continuing series of
lots are in compliance with the requirements of this International Standard, the sampling plans and acceptance
criteria given in Table A.1 shall be applied.
Manufacturers may use the schemes in Table A.1 or may devise and implement validated alternative quality control
methods that result in at least equivalent consumer protection.
When tests are being conducted on fewer than five lots of condoms, the additional protection of the switching rules in
ISO 2859-1 is not available and it is recommended that the sampling plans given in annex B be used to maintain the
level of consumer protection.
Table A.1 — Sampling plans and acceptance criteria for a continuing series of lots
Attributes Inspection level Acceptance criteria
Dimensions 13 condoms All samples shall meet the criteria of length
� 160 mm and width ±2mm of stated
nominal width
Bursting volume and pressure General Inspection Level I as in AQL of 1,5
(untreated/oven-treated) ISO 2859-1
Package integrity Special Inspection Level S-3 AQL of 2,5
Freedom from holes General Inspection Level I but at least AQL of 0,25
code Letter M
Visible defects General Inspection Level I but at least AQL of 0,4
code Letter M
Packaging and labelling 13 consumer packages and 13 individual All shall comply
containers
Applications for these sampling plans may include the following:
a) on-going production testing and quality control by a manufacturer;
b) on-going testing by a purchaser for contractual purposes;
c) on-going inspection by a national authority.
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ISO 4074:2002(E)
Annex B
(informative)
Sampling plans intended for assessing compliance of isolated lots
Use of the sampling plans given in annex A for small numbers of lots, i.e. fewer than five, will result in a higher level
of consumer risk because the switching rules are not available. In such circumstances the use of larger sample sizes
is recommended in order to maintain an acceptable level of consumer protection. The choice of a suitable sampling
plan will be governed by cost considerations. Larger sample sizes will give better discrimination but at increased cost.
Purchasers may, for example, rely upon their experience with a particular supplier when assessing the sample sizes
to use for small numbers of lots.
The sampling plans given in Table B.1, when applied to isolated lots, provide approximately the same level of
consumer protection as those given in annex A when used in conjunction with the switching rules. Attention is drawn
to the possibility of using Double or Multiple Sampling Plans which may reduce the total number of condoms that
need to be tested to demonstrate compliance when quality is significantly better than the AQL’s.
NOTE There is no simple mathematical relationship between the sample size and the lot size. Sample sizes may be increased
independently of the lot size to achieve a more reliable estimate of lot quality.
Table B.1 — Sampling plans and acceptance criteria for isolated lots
Attributes Inspection level Acceptance criteria
Dimensions 13 condoms All samples shall meet the criteria
of length � 160 mm and width ±2mm
of stated nominal width
Bursting volume and pressure General Inspection Level I but at least AQL of 1,5
(untreated/oventreated) Code Letter M as in ISO 2859-1
Package integrity Special Inspection Level S-3 but at least AQL of 2,5
code letter H
Freedom from holes General Inspection Level I b
...