FprEN ISO 4074

Natural rubber latex male condoms - Requirements and test methods (ISO/FDIS 4074:2014)

2015-02-25 - CEN/BT C014/2015 - Appeal resolved - WI stopped and to be replaced by // vote on ISO 4074 minor revision (ISO ID 67615).
2014-06-17- Appeal received from AFNOR
2013-09-25 EMA: Draft for // vote received in ISO/CS (see notification of 2013-09-24).
2012-05-04 EMA: Draft for // ENQ received in ISO/CS (see notification of 2012-05-02 in dataservice).
2012-01-04 EMA: Consultant Virefleau replaced by W. Higgins according to e-mail sent to dataservice on 2011-12-01.

Kondome aus Naturkautschuklatex - Anforderungen und Prüfverfahren (ISO/FDIS 4074:2014)

Diese Internationale Norm legt die anzuwendenden Anforderungen und Prüfverfahren für aus Natur-kautschuklatex hergestellte Kondome für Männer fest.

Préservatifs masculins en latex de caoutchouc naturel - Exigences et méthodes d'essai (ISO/FDIS 4074:2014)

Kondomi iz naravnega kavčuka - Zahteve in preskusne metode (ISO/FDIS 4074:2014)

General Information

• Status: Not Published
• Publication Date: 19-Aug-2014
• Withdrawal Date: 19-Feb-2015
• ICS: 11.200 - Birth control. Mechanical contraceptives
• Technical Committee: CEN/TC 205 - Non-active medical devices
• Drafting Committee: CEN/TC 205 - Non-active medical devices
• Current Stage: 5098 - Decision to abandon - Formal Approval
• Start Date: 25-Feb-2015
• Completion Date: 14-Apr-2025
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/BC/CEN/91/3 - Condoms
• Ref Project: kSIST FprEN ISO 4074:2014 - Natural latex rubber condoms - Requirements and test methods (ISO/FDIS 4074:2014)

Relations

• Revises: EN ISO 4074:2002 - Natural latex rubber condoms - Requirements and test methods (ISO 4074:2002)
• Effective Date: 19-Jan-2023

Overview

FprEN ISO 4074 (ISO/DIS 4074:2012) is the international/CEN standard that specifies requirements and test methods for natural rubber latex male condoms. Developed under ISO/TC 157 and CEN/TC 205, this revision supersedes EN ISO 4074:2002 and consolidates performance, safety and labelling requirements for non‑sterile medical device condoms. The standard addresses design, product claims, manufacturing quality verification, sampling and a comprehensive set of test methods (freedom from holes, bursting volume/pressure, package integrity, stability and shelf life).

Key topics and technical requirements

• Product scope and definitions: Applies to male condoms made from natural rubber latex; includes normative and informative annexes covering methods and guidance.
• Quality verification and lot control: Requirements for lot size (maximum lot size limited in this edition), sampling plans and switching rules to assess ongoing conformity.
• Biocompatibility and microbial control: Manufacturers must follow ISO 10993‑1 principles for biocompatibility assessment and implement periodic monitoring of microbial contamination (bioburden) with limits and pathogen absence requirements.
• Physical performance tests:
  • Freedom from holes (electrical and water leak tests, including “hang and squeeze” integration).
  • Bursting volume and pressure (air inflation methods; clamping collar radius updated).
  • Force and elongation / thickness / dimensions measured by detailed annex procedures.
• Stability and shelf life: Real‑time stability testing is required before market placement; a simplified accelerated ageing procedure (fixed ageing at 50 °C) is included to support shelf‑life estimation.
• Packaging, package integrity and labelling: Requirements to protect condoms during storage and to ensure correct usage information for end users.
• Test reporting and documentation: Detailed requirements for test reports, traceability and supporting evidence for product claims (especially safety/efficacy claims requiring clinical substantiation).

Applications and users

This standard is essential for:

• Condom manufacturers - to design, verify and document compliance for product safety, shelf life and labelling.
• Third‑party test laboratories - to perform standardized physical, microbiological and packaging tests.
• Regulatory authorities and Notified Bodies - for conformity assessment, market surveillance and alignment with EU directives (see Annex ZA referencing Directive 93/42/EEC).
• Procurement, public health programs and NGOs - to specify acceptance criteria and ensure product reliability in STI prevention and contraception programs.

Related standards

• ISO 10993‑1 (biocompatibility assessment)
• ISO 13485 / ISO 9000 (quality management)
• ISO 14971 (risk management)
• ISO 16038 (guideline for applying ISO 4074)
• EU Directive 93/42/EEC (as related in Annex ZA)

Keywords: ISO 4074, natural rubber latex male condoms, condom test methods, freedom from holes, bursting pressure, shelf life testing, microbial contamination, condom packaging, CEN.

Standards Content (Sample)

SLOVENSKI STANDARD
oSIST prEN ISO 4074:2012
01-julij-2012
.RQGRPLL]QDUDYQHJDNDYþXND=DKWHYHLQSUHVNXVQHPHWRGH,62',6

Natural latex rubber condoms - Requirements and test methods (ISO/DIS 4074:2012)
Kondome aus Naturkautschuklatex - Anforderungen und Prüfverfahren (ISO/DIS
4074:2012)
Préservatifs masculins en latex de caoutchouc naturel - Exigences et méthodes d'essai
(ISO/DIS 4074:2012)
Ta slovenski standard je istoveten z: prEN ISO 4074
ICS:
11.200 1DþUWRYDQMHGUXåLQH Birth control. Mechanical
0HKDQVNLNRQWUDFHSFLMVNL contraceptives
SULSRPRþNL
oSIST prEN ISO 4074:2012 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

oSIST prEN ISO 4074:2012
oSIST prEN ISO 4074:2012
EUROPEAN STANDARD
DRAFT
prEN ISO 4074
NORME EUROPÉENNE
EUROPÄISCHE NORM
May 2012
ICS 11.200 Will supersede EN ISO 4074:2002
English Version
Natural latex rubber condoms - Requirements and test methods
(ISO/DIS 4074:2012)
Préservatifs masculins en latex de caoutchouc naturel - Kondome aus Naturkautschuklatex - Anforderungen und
Exigences et méthodes d'essai (ISO/DIS 4074:2012) Prüfverfahren (ISO/DIS 4074:2012)
This draft European Standard is submitted to CEN members for parallel enquiry. It has been drawn up by the Technical Committee
CEN/TC 205.
If this draft becomes a European Standard, 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.

This draft European Standard was established by CEN 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, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom.

Recipients of this draft are invited to submit, with their comments, notification of any relevant patent rights of which they are aware and to
provide supporting documentation.

Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without notice and
shall not be referred to as a European Standard.

EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2012 CEN All rights of exploitation in any form and by any means reserved Ref. No. prEN ISO 4074:2012: E
worldwide for CEN national Members.

oSIST prEN ISO 4074:2012
prEN ISO 4074:2012 (E)
Contents Page
Foreword .3

oSIST prEN ISO 4074:2012
prEN ISO 4074:2012 (E)
Foreword
This document (prEN ISO 4074:2012) 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 document is currently submitted to the parallel Enquiry.
This document will supersede EN ISO 4074:2002.
This document has been prepared under a mandate given to CEN by the European Commission and the
European Free Trade Association, and supports essential requirements of EU Directive(s).
Endorsement notice
The text of ISO/DIS 4074:2012 has been approved by CEN as a prEN ISO 4074:2012 without any
modification.
oSIST prEN ISO 4074:2012
oSIST prEN ISO 4074:2012
DRAFT INTERNATIONAL STANDARD ISO/DIS 4074
ISO/TC 157 Secretariat: DSM
Voting begins on Voting terminates on

2012-05-17 2012-10-17
INTERNATIONAL ORGANIZATION FOR STANDARDIZATION    МЕЖДУНАРОДНАЯ ОРГАНИЗАЦИЯ ПО СТАНДАРТИЗАЦИИ    ORGANISATION INTERNATIONALE DE NORMALISATION

Natural rubber latex male condoms — Requirements and test
methods
Préservatifs masculins en latex de caoutchouc naturel — Exigences et méthodes d'essai
[Revision of first edition (ISO 4074:2002), ISO 4074:2002/Cor.1:2003 and ISO 4074:2002/Cor.2:2008]
ICS 11.200
ISO/CEN PARALLEL PROCESSING
This draft has been developed within the International Organization for Standardization (ISO), and
processed under the ISO-lead mode of collaboration as defined in the Vienna Agreement.
This draft is hereby submitted to the ISO member bodies and to the CEN member bodies for a parallel
five-month enquiry.
Should this draft be accepted, a final draft, established on the basis of comments received, will be
submitted to a parallel two-month approval vote in ISO and formal vote in CEN.

To expedite distribution, this document is circulated as received from the committee
secretariat. ISO Central Secretariat work of editing and text composition will be undertaken at
publication stage.
Pour accélérer la distribution, le présent document est distribué tel qu'il est parvenu du
secrétariat du comité. Le travail de rédaction et de composition de texte sera effectué au
Secrétariat central de l'ISO au stade de publication.

THIS DOCUMENT IS A DRAFT CIRCULATED FOR COMMENT AND APPROVAL. IT IS THEREFORE SUBJECT TO CHANGE AND MAY NOT BE
REFERRED TO AS AN INTERNATIONAL STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS BEING ACCEPTABLE FOR INDUSTRIAL, TECHNOLOGICAL, COMMERCIAL AND USER PURPOSES,
DRAFT INTERNATIONAL STANDARDS MAY ON OCCASION HAVE TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL TO BECOME
STANDARDS TO WHICH REFERENCE MAY BE MADE IN NATIONAL REGULATIONS.
RECIPIENTS OF THIS DRAFT ARE INVITED TO SUBMIT, WITH THEIR COMMENTS, NOTIFICATION OF ANY RELEVANT PATENT RIGHTS OF WHICH
THEY ARE AWARE AND TO PROVIDE SUPPORTING DOCUMENTATION.
©  International Organization for Standardization, 2012

oSIST prEN ISO 4074:2012
ISO/DIS 4074
Copyright notice
This ISO document is a Draft International Standard and is copyright-protected by ISO. Except as permitted
under the applicable laws of the user’s country, neither this ISO draft nor any extract from it may be
reproduced, stored in a retrieval system or transmitted in any form or by any means, electronic,
photocopying, recording or otherwise, without prior written permission being secured.
Requests for permission to reproduce should be addressed to either ISO at the address below or ISO’s
member body in the country of the requester.
ISO copyright office
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Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail [e-mail]
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Reproduction may be subject to royalty payments or a licensing agreement.
Violators may be prosecuted.
ii © ISO 2012 – All rights reserved

oSIST prEN ISO 4074:2012
ISO/DIS 4074
Contents Page
Foreword .v
Introduction.vii
1 Scope.1
2 Normative references.1
2 Terms and definitions .1
3 Quality verification .3
4 Lot size .3
5 Biocompatibility.4
6 Microbial contamination .4
7 Product claims.4
8 Design.4
9 Bursting volume and pressure .5
10 Stability and shelf life.6
11 Freedom from holes.7
12 Visible defects .7
13 Package integrity of individual container .7
14 Packaging and labelling .8
15 Test report.10
Annex A (normative) Sampling plans intended for assessing compliance of a continuing series of
lots of sufficient number to allow the switching rules to be applied.12
Annex B (informative) Sampling plans intended for assessing compliance of isolated lots .14
Annex C (normative) Determination of total lubricant for condoms in individual containers.15
Annex D (normative) Determination of length .18
Annex E (normative) Method for the determination of width.20
Annex F (normative) Determination of thickness.21
Annex G (informative) Determination of microbial contamination .24
Annex H (normative) Determination of bursting volume and pressure .28
Annex I (normative) Oven treatment for condoms.31
Annex J (informative) Determination of force and elongation at break of test pieces of condoms.32
Annex K (normative) Determination of shelf life by real-time stability studies.34
Annex L (informative) Guidance on conducting and analysing accelerated ageing studies .36
Annex M (normative) Testing for holes .38
Annex N (normative) Testing for package integrity .48
Annex O (informative) Calibration of air inflation equipment for determination of bursting volume
and pressure .50
oSIST prEN ISO 4074:2012
ISO/DIS 4074
Annex P (informative) Recommendations for testing condoms that fall outside of the size ranges
specified in ISO 4074. 54
Bibliography. 57
Annex ZA (informative) Relationship between this International Standard and the Essential
Requirements of EU Directives 93/42/EEC. 59

iv © ISO 2012 – All rights reserved

oSIST prEN ISO 4074:2012
ISO/DIS 4074
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 2.
The main task of technical committees is to prepare International Standards. 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 document may be the subject of patent
rights. ISO shall not be held responsible for identifying any or all such patent rights.
ISO 4074 was prepared by Technical Committee ISO/TC 157, Non-systemic contraceptives and STI barrier
prophylactics.
This second edition cancels and replaces the first edition (ISO 4074:2002, ISO 4074:2002/Cor.1:2003,
ISO 4074:2002/Cor.2:2008), which has been technically revised. The modifications are as follows:
a) the maximum lot size has been limited to 500 000;
b) specific requirements for biocompatibility assessments, as defined in ISO 10993-1, have been added;
c) manufacturers are required to establish procedures for the periodic monitoring of microbial contamination
(bioburden) as part of their quality management system including requirements for the absence of specific
pathogens and limits for total viable counts on finished condoms; methods of determining bioburden
levels on condoms are given in Annex G;
d) specific requirements for extra strength condoms have been deleted but there is now a general
requirement for manufacturers to justify any additional claims made for their products; claims relating to
improved efficacy or safety have to be substantiated by clinical investigation;
e) requirements for an expanded range of condom sizes have been introduced in informative Annex P to
provide guidance to regulatory authorities, Notified Bodies and other interested parties when assessing
condoms that fall outside of the size range covered in the normative parts of the standard;
f) amendments have been made to the methods for determining the shelf life of condoms including a
simplified procedure for determining the shelf life by accelerated stability studies based on fixed ageing
periods at 50 °C;
g) the procedure for determining the thickness of a condom by the micrometer method is described in detail;
h) the radius of the clamping collar used in the inflation test described in Annex H has been increased to a
minimum of 2 mm;
i) the volume of electrolyte used in the electrical test for determining freedom from holes described in
Annex M has been brought into line with the volume used for the water leak test;
oSIST prEN ISO 4074:2012
ISO/DIS 4074
j) the ASTM “hang and squeeze” procedure has been integrated into the water leak test for
freedom from holes.
vi © ISO 2012 – All rights reserved

oSIST prEN ISO 4074:2012
ISO/DIS 4074
Introduction
Condoms made from intact latex film have been shown to be a barrier to human immunodeficiency virus (HIV),
other infectious agents responsible for the transmission of sexually transmitted infections (STIs) and to
spermatozoa. Numerous clinical studies have confirmed that male latex condoms are effective in helping to
prevent pregnancy and reduce the risk of transmission of most STIs including HIV.
In order to help ensure that condoms are effective for contraceptive purposes and in assisting in the
prevention of transmission of STIs, it is essential that condoms fit the penis properly, are free from holes, have
adequate physical strength so as not to break during use, are correctly packaged to protect them during
storage and are correctly labelled to facilitate their use. All these issues are addressed in this International
Standard.
Condoms are medical devices. To ensure high quality product, it is essential that condoms produced under a
good quality management system. Reference can be made, for example, to ISO 13485 and the ISO 9000-
series of standards 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.
Requirements for manufacturers to periodically monitor microbial contamination during production are
included in this edition of ISO 4074.
This 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 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.
A guideline ISO 16038 for the application of this International Standard has been published by ISO/TC 157.
The guideline includes additional information on the test methods and requirements specified in this
International Standard.
oSIST prEN ISO 4074:2012
oSIST prEN ISO 4074:2012
DRAFT INTERNATIONAL STANDARD ISO/DIS 4074

Natural rubber latex male condoms — Requirements and test
methods
1 Scope
This International Standard specifies requirements and the test methods for male condoms made from natural
rubber latex.
2 Normative references
The following referenced documents are indispensable for the application 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 10993-5, Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity
ISO 10993-10, Biological evaluation of medical devices — Part 10: Tests for irritation and skin sensitization
ISO 15223-2, Medical devices -- Symbols to be used with medical device labels, labelling, and information to
be supplied -- Part 2: Symbol development, selection and validation
EN 980, Symbols for use in the labelling of medical devices
EN 1041, Information supplied by the manufacturer of medical devices
2 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
[ISO 2859-1]
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
oSIST prEN ISO 4074:2012
ISO/DIS 4074
NOTE If a consumer could reasonably 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 of condoms
3.4
expiry date
date after which the condom should not be used
3.5
identification number
number, or combination of numerals, symbols or letters. used by a manufacturer on consumer packages
to identify uniquely the lot numbers of individual condoms contained in that package, and from which it
is possible to trace those lots through all stages of manufacturing, packaging and distribution
NOTE When the consumer package contains only one type of condom then the identification number may be the
same as the lot number but if the consumer package contains several different types of condoms, for instance condoms
of different shapes or colours, then the identification number will be different from the lot numbers.
3.6
individual container
primary package containing a single condom
3.7
inspection level
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
3.9
lot number
number, or combination of numerals, symbols or letters, used by the manufacturer to identify a lot of
individually packaged condoms, and from which it is possible to trace that lot through all stages of
manufacture up to packaging
3.10
non-visible hole
hole in a condom that is not visible under normal or corrected vision but is detected by the water leak test or
the electrical test described in this International Standard
3.11
sampling plan
specific plan which indicates the number of units of product from each lot which are to be inspected (sample
size or series of sample sizes) and the associated criteria for determining the acceptability of the lot
(acceptance and rejection numbers)
3.12
shelf life
period from date of manufacture, during which condoms are required to conform to the requirements for
bursting pressure, bursting volume, freedom from holes and pack integrity specified in this International
Standard
2 © ISO 2012 – All rights reserved

oSIST prEN ISO 4074:2012
ISO/DIS 4074
3.13
visible hole
hole in the condom that is visible under normal or corrected vision before the condom is filled with water or
electrolyte during testing for freedom from holes
3.14
date of manufacture
date of dipping or the date the condoms are packed in their individual containers provided that, in the latter
case, a maximum period of bulk storage is specified and shelf life studies have been conducted on condoms
that have been subjected to the maximum bulk storage period
3.15
visible defects (other than holes and tears)
broken, missing or severely distorted rim and permanent creases with adhesion of the film
3 Quality verification
Condoms are mass produced articles manufactured in very large quantities. Inevitably there will be some
variation between individual condoms, and a small proportion of condoms in each production run might not
meet the requirements in this International Standard. Further, the majority of the test methods described in
this International Standard are destructive. For these reasons the only practicable method of assessing
conformity with this International Standard is by testing a representative sample from a lot or series of lots.
Basic sampling plans are given in ISO 2859-1. Reference should be made to ISO/TR 8550 for guidance on
the use of acceptance sampling system, scheme or plan for the inspection of discrete items in lots. For testing
purposes, sampling shall be conducted by lot number, not by identification number.
When on-going verification is required of the quality of condoms, it is suggested that, instead of concentrating
solely on evaluation of the final product, attention is also directed at the manufacturer's quality system. In this
[9]
connection it should be noted that, ISO 13485 covers the provision of an integrated quality system for the
manufacture of medical devices.
Sampling plans shall be selected to provide an acceptable level of consumer protection. Suitable sampling
plans are given in Annexes A and B.
a) Annex A describes sampling plans based on ISO 2859-1 and is most applicable to manufacturers or
purchasers assessing the conformity of a continuing series of lots. The full level of consumer protection
available depends upon the switch to tightened inspection if deterioration in quality is detected. The
switching rules, described in ISO 2859-1, Clause 9 cannot offer their full protection for the first two lots
tested but become progressively more effective as the number of lots in a series increases. The sampling
plans in Annex A are recommended when five or more lots are being tested.
b) Annex B describes sampling plans, based on ISO 2859-1, that are recommended for the assessment of
isolated lots. The sampling plans in Annex B provide approximately the same level of consumer
protection as those given in Annex A when used with the switching rules. It is recommended that these
sampling plans are used for the assessment of fewer than five lots, for example in cases of dispute, for
referee purposes, for type testing, for qualification purposes or for short runs of continuing lots.
It is necessary to know the lot size in order to derive from ISO 2859-1 the number of condoms to be tested.
The lot size will vary between manufacturers and is regarded as part of the process and quality controls used
by the manufacturer.
If the lot size is not known or cannot be confirmed by the manufacturer then a lot size of 500 000 shall be
assumed for determining the sample sizes for testing.
4 Lot size
The maximum individual lot size for production shall be 500 000.
oSIST prEN ISO 4074:2012
ISO/DIS 4074
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.
5 Biocompatibility
For any new product or following a significant change to the formulation or manufacturing process
biocompatibility assessments shall be conducted in accordance with ISO 10993-1. Evaluation for cytotoxicity
according to ISO 10993-5, irritation according to ISO 10993-10 and sensitization (delayed contact
hypersensitivity) according to ISO 10993-10 shall be conducted. The condom together with any lubricant,
additive, dressing material, or powder applied to it shall be evaluated.
The laboratory used for any testing shall be accredited by a national accreditation body. The results shall be
interpreted by a qualified toxicologist or any other appropriately qualified expert. The biological assessment
report shall justify that the product is safe for its intended use.
NOTE Many latex products that have been established as safe including condoms and medical gloves can exhibit a
positive cytotoxic response when tested according to ISO 10993-5. Whilst 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.
Regulatory bodies might also specify specific local requirements.
6 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 ISO 11737-
1:2006. The standard includes methods for validating testing (ISO 11737-1:2006, Annex C). The methods described in
Annex G of this International Standard have been found to be suitable for use with condoms taking into account specific
issues associated with testing these products. These issues include the residual antimicrobial activity of some of
compounds used in latex formulations which can interfere with the assays.
NOTE 2 To control microbial contamination on the finished product manufacturers need to control the manufacturing
environment to reduce the risk of contaminating the product, establish general cleaning and sanitizing procedures
throughout the operation and monitor bioburden levels on raw materials and equipment.
7 Product claims
Condoms meeting the requirements of this International Standard may be used for contraceptive purposes
and help protect against sexually transmitted infections. 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. Manufacturers shall justify any additional claims made for their products.
8 Design
8.1 Integral bead
The open end of the condom shall terminate in an integral bead.
4 © ISO 2012 – All rights reserved

oSIST prEN ISO 4074:2012
ISO/DIS 4074
8.2 Lubrication
If verification is required of the quantity of lubricant in a package, the method given in Annex C shall be used.
The criteria of compliance shall be as agreed between the parties concerned.
The method in Annex C also recovers part of the dressing powder on the condom. An allowance should be
made for this when manufacturers or purchasers specify lubricant levels.
8.3 Dimensions
8.3.1 Length
When tested by the method given in Annex D, taking 13 condoms from each lot, no individual measurement
shall be below 160 mm.
8.3.2 Width
When tested by the method given in Annex E measuring at the narrowest part of the condom in the range of
20 mm to 50 mm from the open end, taking 13 condoms from each lot, no measurement of the width shall
deviate from the nominal width stated by the manufacturer by more than ± 2 mm.
Where the design of the condom is such that this measurement cannot be made reliably, for example because
of the shape of the condom or because the narrowest point within the first 50 mm from the open end of the
condom is at the bead, the method of measurement and the point at which the measurement shall be made
shall be provided by the manufacturer.
8.3.3 Thickness
If verification is required of the thickness of a condom, the average thickness, determined in accordance with
one of the methods given in Annex F shall be equal to the claimed thickness, subject to a tolerance of:
⎯ ± 0,008 mm for condoms with thickness less than 0,05 mm;
⎯ ± 0,01 mm for condoms with thickness equal to or greater than 0,05 mm;
9 Bursting volume and pressure
When determined in accordance with Annex H, the bursting pressure shall not be less than 1,0 kPa and the
bursting volume shall be not less than:
⎯ 16,0 dm for condoms with a mid-body width greater than or equal to 45,0 mm and less than 50,0 mm; or
⎯ 18,0 dm for condoms with a mid-body width greater than or equal to 50,0 mm and less than 56,0 mm; or
⎯ 22,0 dm for condoms with a mid-body width greater than or equal to 56,0 mm and less than 65,0 mm.
For the purpose of this test, the mid-body width is the mean flat width of 13 condoms measured in accordance
with Annex E at a point (75 ± 5) mm from the closed end excluding the reservoir tip. The length of the condom
is determined according to 9.3.1.
The compliance level for each lot shall be an AQL of 1,5 for condoms that fail the requirement for bursting
volume, or bursting pressure or both.
Condoms that do not comply with the limits specified above cannot be claimed to meet ISO 4074. For
condoms that have a mid-body width less than 45 mm or greater than 65 mm and/or are shorter than 160 mm
long excluding the reservoir tip, guidelines for bursting pressures and volumes are given in Annex P.
oSIST prEN ISO 4074:2012
ISO/DIS 4074
Authorization to market these products is at the discretion of the appropriate regulatory authorities or Notified
Bodies.
10 Stability and shelf life
10.1 General
Manufacturers shall verify that the condoms comply with the requirements of Clauses 10, 12 and 14 of this
International Standard until the end of the labelled shelf life. Shelf life claims shall not exceed 5 years.
Figure 1 — Shelf life claims shall be verified on condoms that have been stored in bulk for the maximum
permitted period between dipping and packaging that is specified by the manufacturer. The period of bulk
storage between dipping and packaging shall not exceed 2 years.
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 compliance 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 be tested for 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 shelf-life claims as described
in 11.4.
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 11.2 does not imply that the shelf life of the product has been determined.
+5
Shelf life estimates (11.4) shall be based on a mean kinetic temperature of ( ) °C for all climatic conditions
−2
and should be carried out on condoms from the same production lots as used for real-time determination of
shelf life (11.3).
10.2 Minimum stability requirements
Test three lots of condoms for conformity with this International Standard, except for subclauses 15.2 and 15.3.
Only lots meeting all of the requirements of Clauses 9, 10, 12, 13 and 14 shall be used for this test.
Incubate 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 bursting properties according to Annex H and the requirements of
Clauses 10, 12 and 14 using the samples sizes specified in Annex B.
The test report shall include the requirements of Annex H and Clause 16.
NOTE 1 Data to verify compliance with 11.2 can be extracted from studies for estimates of shelf life (11.4).
NOTE 2 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 and other interested parties can use this test
to confirm that condoms meet the minimum stability requirements.
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oSIST prEN ISO 4074:2012
ISO/DIS 4074
10.3 Procedure for determining shelf life by real time stability studies
After testing according to Annex K using the sample sizes specified in Annex B the condoms shall meet the
requirements in Clauses 10, 12 and 14.
If the real-time data indicates a shorter shelf life than that claimed on the basis of accelerated ageing (11.4)
the manufacturer shall notify the relevant regulatory authorities and direct purchasers. The manufacturer shall
change the shelf life claims for the product to one based upon the real time study. In no case shall shelf life
claim exceed 5 years.
For condoms placed on the market based upon accelerated stability studies, real time stability studies shall be
completed for the full period of the shelf life claim.
10.4 Estimating shelf life based upon accelerated stability studies
Pending the completion of real-time studies, manufacturers shall substantiate provisional shelf life claims.
Accelerated stability studies may be used for this purpose.
Further information on accelerated studies is provided in Annex L. Data generated from such studies shall
support the claim that the condoms fulfil the requirements in Clauses 10, 12 and 14 for the duration of the
+5
labelled shelf life at ( 30 ) °C.
−2
11 Freedom from holes
When tested by either method described in Annex M, 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.
NOTE Condoms that cannot be tested using the fill volumes specified in Annex M cannot be claimed to meet
ISO 4074. For condoms that have a mid-body width less than 45 mm or greater than 65 mm and/or are shorter than
160 mm excluding the reservoir tip, guidelines for the volume of water or electrolyte to be used in the freedom from holes
test are given in Annex P. Authorization to market these products is at the discretion of the appropriate regulatory
authorities or Notified Bodies.
12 Visible defects
For visible defects (M.2.3.4, M.3.3.5), the compliance level for each lot shall be an AQL of 0,4.
13 Package integrity of individual container
When individual containers comprising one or more flexible laminated films sealed together are tested in
accordance with Annex N, the compliance level for each lot shall be an AQL of 2,5.
When condoms are tested for freedom from holes according to Annex M the individual containers shall be
inspected for visibly open seals. The compliance level for individual containers having visibly open seals shall
be an AQL of 0,4.
For designs of individual container other than flexible laminated films, the manufacturer shall apply a suitable
pack integrity test. The compliance level for each test shall be an AQL of 2,5. The method given in Annex N
may be used with suitable adjustment to the level of vacuum applied. Details of the test method shall be
provided on request.
oSIST prEN ISO 4074:2012
ISO/DIS 4074
14 Packaging and labelling
14.1 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. If condoms are intended to be supplied only in individual containers, the individual
containers shall be opaque.
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 or loss of lubricant
during normal transport and storage.
Individual containers and any other packaging shall be designed in such a way that the package can be
opened without damaging the condom. The design of the individual container should facilitate easy opening.
14.2 Labelling
Where national regulations apply in relation to labelling they shall take precedence over the requirements in
this International Standard. Where there is no contradiction between national requirements and this
International Standard both shall apply.
14.2.1 Symbols
If symbols are used on packaging, information and marketing materials, the symbols shall meet the
requirements in ISO 15223 and national regulations. For condoms intended for distribution in the European
Union the symbols shall comply with EN 980 and EN 1041.
14.2.2 Individual container
Each individual container shall be indelibly and legibly marked with at least the following information.
a) The identity of the manufacturer or distributor or, if permitted by local regulations the registered brand or
trade mark.
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.
d) Any additional marking required by local regulations. For condoms intended for distribution within the
European Union this includes the CE Mark. Refer to EN 1041 for additional requirements for condoms
intended for distribution within the European Union.
14.2.3 Consumer package
14.2.3.1 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 by the national authority:

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.
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oSIST prEN ISO 4074:2012
ISO/DIS 4074
c) The nominal width of the condom.
d) The name or trade name and full postal address of the manufacturer and/or distributor and European
Authorized Representative, depending on national and regional requirements. A PO Box number is not
an acceptable address.
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.
g) If the individual containers are not opaque to light a statement that individual containers 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. th
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