kSIST FprEN ISO 4074:2014

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.

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oSIST prEN ISO 4074:2012

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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.

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

2

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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.

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oSIST prEN ISO 4074:2012

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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

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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
Case postale 56  CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail copyright@iso.org
Web www.iso.org
Reproduction may be subject to royalty payments or a licensing agreement.
Violators may be prosecuted.

ii © ISO 2012 – All rights reserved

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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
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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

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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;
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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

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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.
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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
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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
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oSIST prEN ISO 4074:2012
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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.
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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
co
...