kSIST FprEN ISO 4074:2025
(Main)Natural rubber latex male condoms - Requirements and test methods (ISO/FDIS 4074:2025)
Natural rubber latex male condoms - Requirements and test methods (ISO/FDIS 4074:2025)
Kondome aus Naturkautschuklatex für Männer- Anforderungen und Prüfverfahren (ISO/FDIS 4074:2025)
Préservatifs masculins en latex de caoutchouc naturel - Exigences et méthodes d'essai (ISO/FDIS 4074:2025)
Kondomi iz naravnega kavčuka - Zahteve in preskusne metode (ISO/FDIS 4074:2025)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
oSIST prEN ISO 4074:2024
01-september-2024
Nadomešča:
SIST EN ISO 4074:2016
Kondomi iz naravnega kavčuka - Zahteve in preskusne metode (ISO/DIS
4074:2024)
Natural rubber latex male condoms - Requirements and test methods (ISO/DIS
4074:2024)
Kondome aus Naturkautschuklatex für Männer- Anforderungen und Prüfverfahren
(ISO/DIS 4074:2024)
Préservatifs masculins en latex de caoutchouc naturel - Exigences et méthodes d'essai
(ISO/DIS 4074:2024)
Ta slovenski standard je istoveten z: prEN ISO 4074
ICS:
11.200 Načrtovanje družine. Birth control. Mechanical
Mehanski kontracepcijski contraceptives
pripomočki
oSIST prEN ISO 4074:2024 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
oSIST prEN ISO 4074:2024
oSIST prEN ISO 4074:2024
DRAFT
International
Standard
ISO/DIS 4074
ISO/TC 157
Natural rubber latex male
Secretariat: DSM
condoms — Requirements and test
Voting begins on:
methods
2024-07-23
Préservatifs masculins en latex de caoutchouc naturel —
Voting terminates on:
Exigences et méthodes d'essai
2024-10-15
ICS: 11.200
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
IS THEREFORE SUBJECT TO CHANGE
AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
PUBLISHED AS SUCH.
This document is circulated as received from the committee secretariat.
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Reference number
ISO/DIS 4074:2024(en)
oSIST prEN ISO 4074:2024
DRAFT
ISO/DIS 4074:2024(en)
International
Standard
ISO/DIS 4074
ISO/TC 157
Natural rubber latex male condoms —
Secretariat: DSM
Requirements and test methods
Voting begins on:
Préservatifs masculins en latex de caoutchouc naturel —
Exigences et méthodes d'essai
Voting terminates on:
ICS: 11.200
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
IS THEREFORE SUBJECT TO CHANGE
AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
PUBLISHED AS SUCH.
This document is circulated as received from the committee secretariat.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
© ISO 2024
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
STANDARDS MAY ON OCCASION HAVE TO
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Published in Switzerland Reference number
ISO/DIS 4074:2024(en)
ii
oSIST prEN ISO 4074:2024
ISO/DIS 4074:2024(en)
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 . 4
6 Biocompatibility . 4
7 Microbial contamination . 4
8 Product claims . 5
9 Design . 5
9.1 Dimensions .5
9.1.1 Length .5
9.1.2 Nominal width .5
9.1.3 Thickness .5
9.2 Integral bead .5
9.3 Lubrication .5
10 Bursting volume and pressure . 5
11 Stability and shelf life . 6
11.1 General .6
11.2 Minimum stability requirements . .7
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. 8
13 Visible defects . 8
14 Package integrity of individual container . 8
15 Packaging and labelling . 8
15.1 Packaging .8
15.2 Labelling .9
15.2.1 General .9
15.2.2 Symbols.9
15.2.3 Individual container .9
15.2.4 Consumer package .9
15.2.5 Condoms not distributed in consumer packages .11
15.3 Inspection .11
16 Test report .12
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 .13
Annex B (informative) Sampling plans intended for assessing compliance of isolated lots .15
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
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oSIST prEN ISO 4074:2024
ISO/DIS 4074:2024(en)
Annex H (normative) Determination of bursting volume and pressure .31
Annex I (normative) Oven treatment for condoms .38
Annex J (informative) Determination of force and elongation at break of test pieces of condoms .39
Annex K (normative) Determination of shelf life by real-time stability studies .42
Annex L (informative) Guidance on conducting and analysing accelerated ageing studies .45
Annex M (normative) Testing for holes .50
Annex N (normative) Testing for package integrity .62
Annex O (normative) Calibration of air inflation equipment for determination of bursting
volume and pressure .66
Annex P (normative) Requirements for testing condoms that fall outside of the length and
width ranges specified in Clause 9 .72
Annex Q (normative) Verification Procedure for the Freedom from Holes Test . 74
Annex ZA (informative) Relationship between this International Standard and the General
Safety and Performance Requirements of Regulation (EU) 2017/745 aimed to be covered .79
Bibliography .81
iv
oSIST prEN ISO 4074:2024
ISO/DIS 4074:2024(en)
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 fourth edition cancels and replaces the third edition (ISO 4074:2015), which has been technically
revised. The main changes are as follows:
a) Annex P has been made normative. The standard now covers all condom sizes including those with
dimensions specified in Annex P.
b) The electrical test for freedom from holes in Annex M has been amended to improve the probability of
finding small holes in the teat (reservoir tip) and closed end of the condom.
c) A new Annex Q is included in the standard which describes procedures for verifying the test methods
[7]
for freedom from holes described in Annex M of this standard and ASTM D3492 are meeting
performance requirements. The procedures may also be used for personnel training and competency
assessment purposes.
d) Improvements have been made to inflation test procedure specified in Annex H.
e) The condom handling procedures described in ISO/TR 19969:2018 have been integrated into Annex H,
testing for burst properties, and Annex M, testing for freedom from holes.
f) A statement has been added to Annex A emphasising that when a minimum sample size is specified
by reference to a specific code letter for a test procedure, that minimum sample size applies even if
reduced inspection is implemented through the use of the switching rules unless it is agreed between
the manufacturer and the purchaser that reduced sampling may be implemented.
g) The use of technical grade propan-2-ol is permitted for removing lubricant from condoms when
determining the lubricant quantity according to Annex C.
h) In Annex G it has been made clear that a Stomacher® is a specific type of mixer that may be used along
with other types of mixers when preparing samples for microbiological testing of condoms. Some
amendments to the test procedures have been made based on current best practices.
v
oSIST prEN ISO 4074:2024
ISO/DIS 4074:2024(en)
i) An alternative dry vacuum method for testing the integrity of individual condom containers has been
included in Annex N. This method provides extra security against leakage, for example when condoms
are being shipped by air freight or to high altitude countries.
j) Annex K has been updated to provide clearer and more detailed information about conducting real time
stability tests.
k) Annex L has been updated to include a more rapid accelerated stability test to assess the effect of process
and formulation changes on the stability of a product and provide a stress test for condoms that may be
stored in high temperature environments.
l) Annex O has been made normative and amended to include a new section to verify that technicians can
unroll the condoms correctly.
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.
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oSIST prEN ISO 4074:2024
ISO/DIS 4074:2024(en)
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.
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
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 condom design before the product is placed on the market and to initiate real-time stability
studies. Manufacturers are also required to consider the stability of any modified condom design. 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.
[5]
ISO 16038 provides guidance for the application of ISO 4074:2015. It includes additional information on
the test methods and requirements specified in this International Standard.
Pictures and diagrams in this standard are to enhance clarity and do not indicate a preference for any
specific equipment type or design.
vii
oSIST prEN ISO 4074:2024
oSIST prEN ISO 4074:2024
DRAFT International Standard ISO/DIS 4074:2024(en)
Natural rubber latex male condoms — Requirements and
test methods
1 Scope
This international standard specifies requirements and test methods for male latex condoms made from
natural rubber latex.
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 skin sensitization
ISO 10993-23, Biological evaluation of medical devices — Part 23: Tests for irritation
ISO 15223-1, Medical devices — Symbols to be used with information to be supplied by the manufacturer — 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
ISO 14971, Medical devices — Application of risk management to medical devices
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]
oSIST prEN ISO 4074:2024
ISO/DIS 4074:2024(en)
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
modified condom design
established condom design that has been subjected to changes in formulation, manufacturing process,
manufacturing site, lubrication, or individual sealed container
3.4
consumer package
package, intended for distribution to a consumer, containing one or more individual containers of condoms
3.5
expiry date
date after which the condom should not be used
3.6
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.
3.7
individual container
primary package containing a single condom
3.8
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]
3.9
inflation length
length of the condom to be inflated during the burst test
3.10
integral bead
ring formed at the open end of the condom, usually by rolling down a portion of the partially dried and cured
latex film, to assist rolling and handling the condom
3.11
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
3.12
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
oSIST prEN ISO 4074:2024
ISO/DIS 4074:2024(en)
3.13
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
3.14
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)
3.15
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
3.16
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
3.17
date of manufacture
date specified by the manufacturer when the product was made subject to the requirements specified in 11.1
3.18
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 regulated medical devices in most countries and should be manufactured and tested using an
appropriate quality management system (QMS). A suitable QMS for the manufacture of medical devices is
[4]
described in ISO 13485 .
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, most 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
[2]
lots. Basic sampling plans are given in ISO 2859-1. Reference should be made 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.
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.
oSIST prEN ISO 4074:2024
ISO/DIS 4074:2024(en)
It is necessary to know the lot size 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.
6 Biocompatibility
For any new product biocompatibility assessments shall be conducted in accordance with ISO 10993-1.
When testing is required, in-vitro tests are preferred if possible. In-vivo (animal) testing should be kept
to a minimum. For a modified condom design manufacturers shall conduct a risk assessment according to
ISO 14971 to determine whether the biocompatibility assessment needs to be repeated.
NOTE 1 Regulatory authorities usually require evaluations to be completed for cytotoxicity according to
ISO 10993-5, irritation according to ISO 10993-23, and sensitization according to ISO 10993-10. Some authorities
might require additional evaluations.
The condom together with any lubricant, additive, dressing material, or powder applied to it shall be
evaluated.
The laboratory used for any biocompatibility testing shall conform to the requirements of ISO/IEC 17025.
The results shall be interpreted by a qualified toxicologist or other appropriately qualified expert. The
biological assessment report shall justify that the product is safe for its intended use.
NOTE 2 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 validation testing (ISO 11737-1:). 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 are recommended 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.
oSIST prEN ISO 4074:2024
ISO/DIS 4074:2024(en)
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 Dimensions
9.1.1 Length
When tested by the method given in Annex D, taking 13 condoms from each lot, no individual measurement
shall be below 160 mm except for condoms with dimensions specified in Annex P. For condoms shorter than
160 mm the length shall be within ±5 mm of the nominal length specified by the manufacturer.
9.1.2 Nominal 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.
9.1.3 Thickness
This standard does not specify limits for condom thickness. If verification is required of the thickness of a
condom design, the average thickness of the samples measured 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.
9.2 Integral bead
The open end of the condom shall terminate in an integral bead.
9.3 Lubrication
This standard does not specify requirements for the quantity and type of lubricant. 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.
Note 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.
10 Bursting volume and pressure
The bursting properties of condoms shall be determined according to the method specified in Annex H. For
condoms that are equal to or greater than 160 mm in length, an inflation length of (150 ± 3) mm shall be
used. The minimum bursting pressures and volumes are specified in Table 1:
oSIST prEN ISO 4074:2024
ISO/DIS 4074:2024(en)
Table 1 — Minimum bursting pressure and volume for condoms ≥ 160 mm long
Width of condom Minimum bursting pressure Minimum bursting volume
mm kPa dm
45,0 to 49,5 1,0 16,0
50,0 to 55,5 1,0 18,0
56,0 to 64,5 1,0 22,0
65,0 to 75,0 0,8 28,0
For the purpose of this test, the mid-body width is the mean width rounded to the nearest 0,5 mm of
13 condoms measured in accordance with Annex E at a point equal to half the inflation length ±5 mm from
the closed end excluding the teat. For example, condoms longer than 160 mm have an inflation length of
150 mm and a mid-body width measured at 75 ± 5 mm from the closed end, excluding the teat.
For condoms that are shorter than 160 mm in length, the inflation lengths and minimum burst properties
are specified in Annex P.
The conformance 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.
11 Stability and shelf life
11.1 General
Manufacturers shall verify that the condoms conform with the requirements of Clauses 10, 12, and 14 until
the end of the labelled shelf life. Products on the market prior to publication of ISO 4074:2015 (2015-10-15)
shall be deemed to conform with the shelf life claims of this International Standard unless the product is a
modified design. Shelf life claims shall not exceed 5 years from the date of manufacture.
The date of manufacture can be the date of dipping or the date of packaging in individual sealed containers,
depending upon the procedures specified by the manufacturer. The date of manufacture shall not exceed
2 years from the date of dipping.
Unpackaged condoms shall be stored under controlled conditions as specified by the manufacturer between
dipping and packaging. Manufacturers shall have documented procedures for validating the storage
conditions and maximum storage period for each product design. The stored condoms shall be protected
from exposure to excessive temperatures, light, ozone, and any other condition that could affect the shelf life
of the packaged condoms.
Assessment for minimum stability (11.2) and shelf life claims (11.3) and (11.4) shall be verified on condoms
that have been stored in bulk for the maximum permitted period between dipping and packaging and under
the conditions specified by the manufacturer.
Data supporting the shelf life claims made by the manufacturer shall be made available on request to
interested parties including regulatory authorities, notified bodies and testing laboratories.
Before conformance with this International Standard may be claimed for a new or modified condom design,
the manufacturer shall provide evidence that the following requirements have been met:
— the condom shall conform with the minimum stability requirements as described in 11.2;
— a real-time study as described in 11.3 to determine shelf life shall have commenced;
— pending completion of the real-time study, manufacturers shall substantiate provisional shelf-life claims
as described in 11.4.
NOTE 1 Conformance with the requirements of 11.2 does not imply that the shelf life of the product has been
determined.
oSIST prEN ISO 4074:2024
ISO/DIS 4074:2024(en)
NOTE 2 A practical limit of 5 years has been set for the shelf life because manufacturers have no control over
storage conditions once condoms have been distributed.
+5
Shelf life estimates (11.4) shall be based on a temperature of 30 °C for all climatic conditions and should be
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−2
carried out on condoms from the same production lots as used for real-time determination of shelf life (11.3).
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NOTE 3 The choice of 30 °C as the reference temperature for shelf life estimates is based on studies that have
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[11,12]
confirmed the mean kinetic temperate of the most extreme temperature zones is approximately 30 °C. See
Annex L for more details.
11.2 Minimum stability requirements
Test three lots of condoms for conformity with this International Standard, except for clause 15.2 and 15.3.
Only lots meeting all the requirements of Clauses 9, 10, 12, 13, and 14 shall be used for this test.
Condition samples in their individual sealed containers according to Annex I, one set for (168 ± 2) 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 conformance with the requirements of Clauses 10, 12, and 14 using as a minimum
the sampling plans specified in Annex A or preferably the sampling plans in Annex B.
This test ensures that the condoms have adequate stability to be placed on the market pending verification of
shelf life claims. It is not predictive of shelf life. Purchasers, test laboratories, regulatory authorities, and other
interested parties may confirm that condoms meet the minimum stability requirements by testing condom
lots for compliance with the requirements of Clause 10 after oven conditioning for (168 ± 2) h (1 week) at
(70 ± 2) °C. When such testing is carried out, it might be appropriate to use reduced inspection levels.
The test report shall include the relevant requirements of Annexes H, K, M and N, and Clause 16.
NOTE Data to verify compliance with 11.2 can be extracted from studies for estimates of shelf life (11.4).
11.3 Procedure for determining shelf life by real-time stability studies
Real-time stability testing shall be conducted on three lots of condoms meeting all the requirements of
Clauses 9, 10, 12, 13, and 14. Real-time stability studies shall continue for the full period of the shelf life
claim. In no case shall shelf life claim exceed 5 years.
For condoms placed on the market based upon accelerated stability studies, if the real-time data indicates
a shorter shelf life than that claimed based on accelerated ageing (11.4), 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.
Test three lots of condoms for conformity with this International Standard, except for 15.2 and 15.3.
After testing according to Annex K using the sampling p
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