SIST EN ISO 4074:2026

SLOVENSKI STANDARD
01-junij-2026
Nadomešča:
SIST EN ISO 4074:2016
Kondomi iz naravnega kavčuka - Zahteve in preskusne metode (ISO 4074:2026)
Natural rubber latex male condoms - Requirements and test methods (ISO 4074:2026)
Kondome aus Naturkautschuklatex für Männer- Anforderungen und Prüfverfahren (ISO
4074:2026)
Préservatifs masculins en latex de caoutchouc naturel - Exigences et méthodes d'essai
(ISO 4074:2026)
Ta slovenski standard je istoveten z: EN ISO 4074:2026
ICS:
11.200 Načrtovanje družine. Birth control. Mechanical
Mehanski kontracepcijski contraceptives
pripomočki
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN ISO 4074
EUROPEAN STANDARD
NORME EUROPÉENNE
April 2026
EUROPÄISCHE NORM
ICS 11.200 Supersedes EN ISO 4074:2015
English Version
Natural rubber latex male condoms - Requirements and
test methods (ISO 4074:2026)
Préservatifs externes en latex de caoutchouc naturel - Kondome aus Naturkautschuklatex für Männer -
Exigences et méthodes d'essai (ISO 4074:2026) Anforderungen und Prüfverfahren (ISO 4074:2026)
This European Standard was approved by CEN on 22 February 2026.

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

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2026 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 4074:2026 E
worldwide for CEN national Members.

Contents Page
European foreword . 3
Annex ZA (informative) Relationship between this International Standard and the General
Safety and Performance Requirements of Regulation (EU) 2017/745 aimed to be
covered. 4

European foreword
This document (EN ISO 4074:2026) 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 October 2026, and conflicting national standards shall
be withdrawn at the latest by April 2029.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 4074:2015.
This document has been prepared under a standardization request addressed to CEN by the European
Commission. The Standing Committee of the EFTA States subsequently approves these requests for its
Member States.
For the relationship with EU Legislation, see informative Annex ZA, which is an integral part of this
document.
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. A complete listing of these bodies can be found on the CEN website.
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, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and the
United Kingdom.
Endorsement notice
The text of ISO 4074:2026 has been approved by CEN as EN ISO 4074:2026 without any modification.

Annex ZA
(informative)
Relationship between this International Standard and the General Safety
and Performance Requirements of Regulation (EU) 2017/745 aimed to be
covered
This European standard has been prepared under M/575 to provide one voluntary means of
conforming to the General Safety and Performance Requirements of Regulation (EU) 2017/745 of 5
April 2017 concerning medical devices [OJ L 117] and to system or process requirements including
those relating to quality management systems, risk management, post-market surveillance systems,
clinical investigations, clinical evaluation or post-market clinical follow-up.
Once this standard is cited in the Official Journal of the European Union under that Regulation,
compliance with the normative clauses of this standard given in 0 and application of the edition of the
normatively referenced standards as given in 0 confers, within the limits of the scope of this standard, a
presumption of conformity with the corresponding General Safety and Performance Requirements of
that Regulation, and associated EFTA Regulations.
Where a definition in this harmonised standard differs from a definition of the same term set out in
Regulation (EU) 2017/745, the differences shall be indicated in the Annex ZA. For the purpose of using
this standard in support of the requirements set out in Regulation (EU) 2017/745, the definitions set
out in this Regulation prevail.
Where the European standard is an adoption of an International Standard, the scope of this document
can differ from the scope of the European Regulation that it supports. As the scope of the applicable
regulatory requirements differ from nation to nation and region to region the standard can only
support European regulatory requirements to the extent of the scope of the European Regulation for
medical devices ((EU) 2017/745).
NOTE 1 Where a reference from a clause of this standard to the risk management process is made, the risk
management process needs to be in compliance with Regulation (EU) 2017/745. This means that risks have to be
‘reduced as far as possible’, ‘reduced to the lowest possible level’, ‘reduced as far as possible and appropriate’,
‘removed or reduced as far as possible’, ‘eliminated or reduced as far as possible’, ’removed or minimized as far as
possible’, or ‘minimized’, according to the wording of the corresponding General Safety and Performance
Requirement.
NOTE 2 The manufacturer’s policy for determining acceptable risk must be in compliance with General Safety
and Performance Requirements 1, 2, 3, 4, 5, 8, 9, 10, 11, 14, 16, 17, 18, 19, 20, 21 and 22 of the Regulation.
NOTE 3 When a General Safety and Performance Requirement does not appear in 0, it means that it is not
addressed by this European Standard.
Table ZA.1 — Correspondence between this European standard and Annex I of Regulation (EU)
2017/745 [OJ L 117] and to system or process requirements including those relating to quality
management systems, risk management, post-market surveillance systems, clinical
investigations, clinical evaluation or post-market clinical follow-up
General Safety and Clause(s) / subclause(s) of Remarks / Notes
this Standard
Performance Requirements
of Regulation (EU) 2017/745
I.4., 2nd paragraph 15.2.4.1 Partially covered.
15.2.4.2 The GSPR is covered in respect to
the risk of allergic reactions
(15.2.4.1).
The GSPR is covered in respect to
the risk of reuse (15.2.4.2).
The GSPR is covered in respect of
the user causing damage to the
device or misusing the deice in a
manner that increases the risk of
failing during use (15.2.4.2).
I.6 11.2, 11.3, 11.4 Partially covered
Covered in respect to:
a)  compliance to the same test
limits as in the original tests after
production after artificial ageing
(stability test, 11.2);
b)  determination of shelf life by
real time stability studies (11.3);
c)  estimating shelf life based upon
accelerated stability studies (11.4).
I.7 Clause 14, Clause 15 Partially covered
Clause 14 describes a test method
to assure the integrity of the
primary package while clause 15
describes requirements for
packaging and also labelling
information that assure that there
cannot be an adverse effect by
temperature and humidity.
II.10.1 f) and h) Clause 10, Clause 11, Fully covered
Clause 12, Clause 14
The requirements in these clauses
ensure the products meet the
physical performance levels
required to provide acceptable
levels of protection.
— 10.1 f) airburst test clause 10;
— 10.1 h) requirements for tests in
clause 10, clause 11, clause 12 and
clause 14.
General Safety and Clause(s) / subclause(s) of Remarks / Notes
this Standard
Performance Requirements
of Regulation (EU) 2017/745
III.23.1 (g) 15.2.4.1 k) Partially covered.
15.2.4.2 a), e) The GSPR is covered in respect to
the risk of allergic reactions only
[15.2.4.1 k)].
The GSPR is covered in respect to
the risk of allergic reactions and
reuse only [15.2.4.1 a) and e)].
III.23.2 a), e), g), i), k), m) 15.2.3 b), c) Partially covered
15.2.4.1 e), f), g), h), i), j), k), The clauses of GSPR 23.2 are
m) covered by the following clauses of
the document:
15.2.4.2 a) - e)
— III.23.2 a): 15.2.4.1 e)
— III.23.2 e): 15.2.4.1 i)
— III.23.2 g): 15.2.3 b)
and 15.2.4.1 j)
— III.23.2 i): 15.2.3 c) and
15.2.4.1 f)
— III.23.2 k): 15.2.4.1 g),
h)
— III.23.2 m): 15.2.4.1 k)
and m) and 15.2.4.2 a)-e)
III 23.4 a), g), h), p), q), s), w) 15.2.4.1 c), d), e), g), h), i), j), Partially covered
k), m)
The clauses of GSPR 23.4 are
15.2.4.2 a), b), e) covered by the following clauses of
the document:
— III.23.4 a): 15.2.4.1 e),
g)-h), j) and m)
— III.23.4 g): 15.2.4.1 k)
and 15.2.4.2 b) a)-b) and e)
— III.23.4 h): 15.2.4.1 c)
and d)
— III.23.4 p): 15.2.4.2 a)
— III.23.4 q): 15.2.4.2 b)
6)
— III.23.4 s): 15.2.4.1 and
15.2.4.2 div. sub points
— III.23.4 w): 15.2.4.2. b)
7)
Table ZA.2 — Normative references from Clause 2 of this document and their corresponding
European publications
Column 1 Column 2 Column 3 Column 4
Reference in International
Title Corresponding European
Clause 2 Standard Edition
Standard Edition
ISO 2859-1 ISO 2859-1:1999 Sampling procedures for None
inspection by attributes — Part 1:
ISO 2859- For applicable standard
Sampling schemes indexed by
1:1999/Cor edition see Column 2
acceptance quality limit (AQL) for
1:2001
lot-by-lot inspection
ISO 2859-
1:1999/Amd 1:20
ISO 10993-1 ISO 10993-1:2018 Biological evaluation of medical EN ISO 10993-1:2020
devices — Part 1: Evaluation and
testing within a risk management
process
ISO 14971 ISO 14971:2019 Medical devices — Application of EN ISO 14971:2019
risk management to medical
EN ISO 14971:2019/A11:20
devices
ISO 15223-1 ISO 15223-1:2021 Medical devices — Symbols to be EN ISO 15223-1:2021
used with information to be
supplied by the manufacturer —
Part 1: General requirements
ISO/IEC 17025 ISO/IEC 17025:20 General requirements for the EN ISO/IEC 17025:2017
17 competence of testing and
calibration laboratories
The documents listed in the Column 1 of 0, in whole or in part, are normatively referenced in this
document, i.e. are indispensable for its application. The achievement of the presumption of conformity
is subject to the application of the edition of Standards as listed in Column 4 or, if no European Standard
Edition exists, the International Standard Edition given in Column 2 of 0.
WARNING 1 Presumption of conformity stays valid only as long as a reference to this European
standard is maintained in the list published in the Official Journal of the European Union. Users of this
standard should consult frequently the latest list published in the Official Journal of the European
Union.
WARNING 2 Other Union legislation may be applicable to the product(s) falling within the scope of this
standard.
International
Standard
ISO 4074
Fourth edition
Natural rubber latex male
2026-03
condoms — Requirements and test
methods
Préservatifs externes en latex de caoutchouc naturel — Exigences
et méthodes d'essai
Reference number
ISO 4074:2026(en) © ISO 2026
ISO 4074:2026(en)
© ISO 2026
All rights reserved. Unless otherwise specified, or required in the context of its implementation, 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
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii
ISO 4074:2026(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 . 9
15.1 Packaging .9
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 . 12
16 Test report .12
Annex A (normative) Sampling plans intended for assessing conformance 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 conformance 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

iii
ISO 4074:2026(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 (informative) 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
Bibliography .79

iv
ISO 4074:2026(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 document 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).
ISO draws attention to the possibility that the implementation of this document may involve the use of (a)
patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed patent
rights in respect thereof. As of the date of publication of this document, ISO had not received notice of (a)
patent(s) which may be required to implement this document. However, implementers are cautioned that
this may not represent the latest information, which may be obtained from the patent database available at
www.iso.org/patents. ISO shall not be held responsible for identifying any or all such patent rights.
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and expressions
related to conformity assessment, as well as information about ISO's adherence to the World Trade
Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 157, Non-systemic contraceptives and STI
barrier prophylactics, in collaboration with the European Committee for Standardization (CEN) Technical
Committee CEN/TC 205, Non-active medical devices, in accordance with the Agreement on technical
cooperation between ISO and CEN (Vienna Agreement).
This fourth edition cancels and replaces the third edition (ISO 4074:2015), which has been technically
revised.
The main changes are as follows.
— The Scope (Clause 1) has been amended because this document now covers all condom sizes including
those with dimensions specified in Annex P, which has been made normative.
— A statement has been added to Annex A regarding the sample sizes used for reduced inspection.
— The use of technical grade propan-2-ol is permitted for removing lubricant from condoms when
determining the lubricant quantity according to Annex C.
— In Annex G, it has been made clear that a Stomacher® is a specific type of mixer that can 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.
— Improvements have been made to inflation test procedure specified in Annex H.
— 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.
— Annex K has been updated to provide clearer and more detailed information about conducting real time
stability tests.
— 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 might be
stored in high temperature environments.

v
ISO 4074:2026(en)
— 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.
— An alternative dry vacuum method for testing the integrity of individual condom containers has been
included in Annex N.
— Annex O has been made normative and amended to include a new section to verify that technicians can
unroll the condoms correctly when conducting the burst test.
— A new Annex Q has been added to specify requirements and procedures for validating new or modified test
procedures and verifying that the test methods for freedom from holes meet the specified performance
requirements. As a consequence, Annex M has been made informative.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www.iso.org/members.html.

vi
ISO 4074:2026(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 document.
Condoms are medical devices. To ensure high quality product, it is essential that condoms are produced
[7]
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 document. Methods that can be used to determine bioburden levels are
included in Annex G.
This document 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 can be subject to specific local requirements as required by national regulatory bodies in addition
to those specified in this document.
[8]
ISO 16038 provides guidance for the application of this document. It includes additional information on
the test methods and requirements specified in this document.
Pictures and diagrams in this document are to enhance clarity and do not indicate a preference for any
specific equipment type or design.
There are no requirements for determining the tensile properties of condoms in this document. Nevertheless,
tensile testing is sometimes used for quality control and development purposes. Annex J includes guidance
on how to determine force and elongation at break of condoms.
The need for a transition period when implementing the requirements of this document should be considered
to allow manufacturers to make the changes required to maintain conformance.

vii
International Standard ISO 4074:2026(en)
Natural rubber latex male condoms — Requirements and test
methods
1 Scope
This document specifies requirements and test methods for male condoms made from natural rubber latex.
This document does not specify requirements related to any medicinal substances applied to or delivered by
the condom.
NOTE The safety and effectiveness of any medicinal substance are assessed according to national and regional
regulations.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content constitutes
requirements of this document. 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 14971, Medical devices — Application of risk management to medical devices
ISO 15223-1, Medical devices — Symbols to be used with information to be supplied by the manufacturer—
Part 1: General requirements
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.
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https://www.iso.org/obp
— IEC Electropedia: available at https://www.electropedia.org/
3.1
acceptance quality limit
AQL
quality level that is the worst tolerable process average when a continuing series of lots (3.11) 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

ISO 4074:2026(en)
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
box, bag or container 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 (3.4)
to identify uniquely the lot numbers (3.12) of individual condoms contained in that package, and from which
it is possible to trace those lots (3.11) 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 (3.11)
of individually packaged condoms, and from which it is possible to trace that lot through all stages of
manufacture up to packaging
3.13
non-visible hole
puncture or tear in a condom that is not visible under normal or corrected vision but is detected by the
water leak test or electrical test

ISO 4074:2026(en)
3.14
sampling plan
specific plan which indicates the number of units of product from each lot (3.11) 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
3.16
visible hole
puncture or tear 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
Note 1 to entry: See 11.1.
3.18
visible defect
broken, missing, or severely distorted bead and permanent creases with adhesion of the film
Note 1 to entry: This refers to visible defects other than holes.
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
[7]
described in ISO 13485.
Condoms are mass produced articles. 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
document. Further, most of the test methods described in this document are destructive. For these reasons,
the only practicable method of assessing conformity with this document 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 the ISO/TR 8550 series 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 shall be used when a continuing series of five or more lots are being tested.
b) When testing isolated lots or fewer than 5 lots, the level of consumer protection is reduced because the
switching rules cannot be applied. If in such cases it is necessary to maintain high levels of consumer
protection the sampling plans in Annex B are recommended. 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. Examples of when the sampling plans in Annex B should be used include cases of dispute,
for referee purposes, for type testing, for qualification purposes, and for short runs of continuing lots.

ISO 4074:2026(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.
This document 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 in accordance with
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 biocompati
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