UGANDA STANDARD
 
      US ISO 
         16038
First Edition
2009-mm-dd
 
Reference numbe r
    US ISO 16038:2005
 © UNBS 2009
  
Rubber condoms — Guidance on the use of ISO 4074 in the 
quality management of natural rubber latex condoms 
 US ISO 16038:2005 
 
© UNBS  2009 – All rights reserved ii Compliance with this standard does not, of itself confer immunity from legal obligations 
A Uganda Standard does not purport to include all necessary provisions of a contract. Users are 
responsible for its correct application  
© UNBS 2009 
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilised in any 
form or by any means, electronic or mechanical, in cluding photocopying and microfilm, without prior written 
permission from UNBS. 
Requests for permission to reproduce this document should be addressed to 
The Executive Director 
Uganda National Bureau of Standards 
P.O. Box 6329 
Kampala  
Uganda 
Tel: 256 41 505 995 
Fax: 256 41 286 123 
E-mail: unbs@infocom.co.ug
Web: www.unbs.go.ug  
   US ISO 16038:2005  
© UNBS  2009 - All rights rese rved                iii National foreword 
Uganda National Bureau of Standards (UNBS) is a parastatal under the Ministry  of Tourism, Trade and 
Industry established under Cap 327, of the Laws of U ganda. UNBS is mandated to co-ordinate the elaboration 
of standards and is  
(a) a member of International Organisation for Standardisation (ISO) and  
(b) a contact point for the WHO/FAO Codex A limentarius Commission on Food Standards, and  
(c) the National Enquiry Point on TBT/SPS Agr eements of the World Trade Organisation (WTO). 
The work of preparing Uganda Standards is carried out through Technical Committees. A Technical 
Committee is established to deliberate on standards in a gi ven field or area and consists of representatives of 
consumers, traders, academician s, manufacturers, governme nt and other stakeholders. 
Draft Uganda Standards adopted by the Technical Committ ee are widely circulated to stakeholders and the 
general public for comments. The committee reviews the comments before recommending the draft standards 
for approval and declaration as Uganda Standards by the National Standards Council. 
This Uganda Standard, US ISO 16038 Rubber condoms— Guidance on the use of ISO 4074 in the quality
management of natural rubber latex condoms, is identical with and has been reproduced from an 
International Standard, ISO 16038:2005 Rubber condoms— Guidance on the use of ISO 4074 in the quality 
management of natural rubber latex condoms, and has been adopted as a Uganda Standard.  
This standard was developed by the Medical devices' Standards Technical Committee (UNBS/TC 14). 
Wherever the words, "International Standard" a ppear, they should be replaced by "Uganda Standard." 
 INTERNATIONAL
STANDARDISO
16038
First edition
2005-11-01
Reference number
ISO16038:2005(E)
© ISO2005Rubber condoms — Guidance on the use 
of ISO 4074 in the quality management of natural rubber latex condoms
Préservatifs en caoutchouc — Directives sur l'utilisation de l'ISO 4074 
dans le management de la qualité des préservatifs en latex de 
caoutchouc naturel
                                    
ISO 16038:2005(E)
ii © ISO 2005 –All rights reservedPDF disclaimer
This PDF file may contain embedded typefaces. In accordance with Adobe's licensing policy, this file may be printed or viewed b ut shall
not be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing. In
downloading this file, parties accept therein the responsibility of not infringing Adobe's licensing policy. The ISO Central Se cretariat
accepts no liability in this area.
Adobe is a trademark of Adobe Systems Incorporated.
Details of the software products used to create this PDF file can be found in the General Info relative to the file; the PDF-cr eation
parameters were optimized for printing. Every care has been taken to ensure that the file is suitable for use by ISO member bod ies. In the
unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below.
© ISO 2005
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by an y means,
electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address be low 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 11Fax + 41 22 749 09 47E-mail copyright@iso.orgWeb www.iso.org
Published in SwitzerlandISO 16038:2005(E)
© ISO 2005 –All rights reserved iiiContents  Page
1 Scope ........................................................................................................................ ............................ 1
2 Normative references ......................................................................................................... ................. 1
3 Terms and definitions ........................................................................................................ .................. 1
4 Quality of design ............................................................................................................ ...................... 1
4.1 General .................................................................................................................... ............................. 1
4.2 Clinical investigation ..................................................................................................... ...................... 2
4.3 Risk management ............................................................................................................ .................... 2
5 Quality of manufacture ....................................................................................................... ................. 3
5.1 Quality management ......................................................................................................... .................. 3
5.2 Lot testing (finished-product testing) ..................................................................................... ........... 3
5.3 Rounding-off values ........................................................................................................ .................... 3
6 Quality in procurement ....................................................................................................... ................. 3
7 Quality in testing ........................................................................................................... ....................... 4
8 Important parameters to be considered when using ISO 4074 ....................................................... 4
8.1 Size ....................................................................................................................... ................................ 4
8.2 Resistance to breakage ..................................................................................................... ................. 5
8.3 Compatibility of materials ................................................................................................. ................. 5
8.4 Shelf-life and resistance to degradation ................................................................................... ........ 5
8.5 Packaging and labelling .................................................................................................... .................. 9
8.6 Type testing ............................................................................................................... .......................... 9
8.7 Lubricants ................................................................................................................. ......................... 10
9 Sampling ..................................................................................................................... ........................ 10
Bibliography .................................................................................................................. ............................. 11ISO 16038:2005(E)
iv © ISO 2005 –All rights reservedForeword
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 ISOtechnical committees. Each member body interested in a subject for which a technical committee has beenestablished 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, Part2.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 16038 was prepared by Technical Committee ISO/TC 157, 
Mechanical contraceptives .ISO 16038:2005(E)
© ISO 2005 –All rights reserved vIntroduction
Condoms are medical devices used for contraception and for prevention of sexually transmitted infections.
ISO 4074 is a quality standard for natural rubber latex condoms. It is a reference document for standardised
end-product quality test protocols and a baseline specification for critical attributes that affect condom safetyand effectiveness. It is applied by manufacturers, procurement agencies, regulatory bodies and testinglaboratories.
The use of ISO 4074 does not by itself ensure consistency in quality; consistent high quality at the lowest
possible cost is attained ONLY through a regime termed quality management, through which, quality is built intothe product and assured at every point in the design, planning, production and procurement processes. ThisInternational Standard should lead to continuous improvement in manufacturing, procurement and testing
processes. The special requirements of buyers and consumers should also be given due consideration when
applying ISO 4074, as ISO 4074 is general by design, and will not cover completely all circumstances.
This International Standard is a guidance document providing manufacturers, buyers, and third-party test
laboratories guidance to implement and apply ISO 4074 in the manufacture of condoms and for purchasers to
apply ISO 4074 as a technical specification and to verify that condoms delivered, comply with the specification.
In order to be acceptable, condoms need to meet or exceed the minimum requirements specified in ISO4074.
It is not possible, nor is it required, to subject condoms to user trials on a batch-by-batch basis. For this reason,
certain evaluations are carried out only in the case of a pre-market validation; for example for new orsignificantly modified designs.
Design validation requirements normally include all the GMP validation requirements and the validation
requirements of ISO9001; these are not currently covered by ISO 4074, but are generally included byregulatory authorities as prerequisites for registering new designs of medical devices. Design considerationssuch as stability testing, etc. are however covered in ISO4074.
ISO 4074 is mainly concerned with finished product testing carried out to monitor or to verify that the condoms
have been manufactured with adequate level of consistency in quality. For this purpose, tests have beendesigned that can be carried out rapidly and economically. The requirements in ISO 4074 are based on thoseproperties which, based upon current knowledge, are believed to be relevant to the performance of condoms in
normal use.
Some important properties of condoms are nevertheless difficult to define in quantitative terms because of lack
of controlled studies, the absence of practical and economical tests, and the need for different specifications tosuit different users. ISO4074 is therefore focused on the essential properties where limits can be clearly
defined. Other properties are addressed only in general terms and are meant to be augmented through
appropriate manufacturing records, certification by the manufacturer or by buyers' specifications.
This International Standard also addresses how to deal with other important issues not covered by  ISO 4074.
It is meant to help the user of ISO 4074 to understand any risks that may be associated with the use of
condoms. It also helps in deciding whether such risks are acceptable when weighed against the benefits to theuser. ISO 4074 also helps in assessing whether the products are demonstrably safe and offer protection tohealth. Good communication between the buyer and the manufacturer will result in the delivery of satisfactoryand safe products, thus avoiding unnecessary testing or inappropriate specifications, thereby minimizingcompliance testing costs.
It should also be noted that in many countries condoms being medical devices are subject to appropriate
regulations.ISO 16038:2005(E)
vi © ISO 2005 –All rights reservedInformation about standards can be obtained through catalogues issued by ISO, IEC, national standards bodies
and regulatory agencies. List of projects under development by various ISO technical committees can be found
in the ISO technical programme of each committee. Additional useful information can also be found bysearching in the work program documents for a specific technical committee or its working groups. Thecatalogues and abstracts are issued yearly to the member bodies.
Modern technology opens up the opportunity for new ways to disseminate information about standards. Many
national member bodies issue information on CD-ROM. Information also can be found on the World Wide Web
by searching for quality-related subjects or under ISO. It is possible to search for information by committees, bypublished standards, and in a standards catalogue. It is also possible to obtain information on the revision statusof a standard and the expected time of publication. This information is updated regularly, and it is therefore anextremely useful tool to search for standards in a given field and the stage of development.
—ISO on-line has the address http://www.iso.org;
—IEC on-line has the address http://www.iec.ch.
On both of these servers, links to member bodies which also have additional services are available, sometimes
by subscription.
Other useful documents are given in the Bibliography.INTERNATIONAL STANDARD ISO 16038:2005(E)
© ISO 2005 –All rights reserved 1Rubber condoms — Guidance on the use of ISO 4074 in the 
quality management of natural rubber latex condoms
1S c o p e
This International Standard provides guidance on using ISO 4074 and addresses quality issues to be
considered during the development, manufacture, quality verification and procurement of condoms. Itencompasses the aspects of quality management systems in design, manufacture and delivery of condoms
with emphasis on performance, safety and reliability of condoms.
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 31-0:1992, Quantities and units — Part0: General principles
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 4074:2002, Natural latex rubber condoms — Requirements and test methods
ISO 9000, Quality management systems — Fundamentals and vocabulary
ISO 14155-1, Clinical investigation of medical devices for human subjects — Part 1: General requirements
ISO 14155-2, Clinical investigation of medical devices for human subjects — Part 2: Clinical investigation plans
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 4074 and ISO 9000 apply.
4 Quality of design
4.1 General
The condom is a single-use medical device, the performance and safety of which depends upon the design and
the manufacturing process. New designs of condoms may require clinical testing, several other tests and
analysis ‘on a limited basis' for validation purposes such as shelf-life determination (type testing) and risk
assessment. These requirements are generally prescribed by licensing authorities and the data generatedbecome part of the master file for the product. Guidelines are available in ISO 9000 and the GMP requirements.When new products are developed, their design should conform to the requirements of design control as laiddown in ISO 9001 and GMP requirements.ISO 16038:2005(E)
2 © ISO 2005 –All rights reservedThe design control principles should be applied to parameters such as shape of condoms; dimensions; critical
components in formulation such as antioxidants, vulcanizers, stabilizers, colorants, etc.; lubricants and additives
such as flavour, additional lubricants etc; and packaging materials. Design control activities should bedocumented as part of the quality management system documentation, reviewed and updated, when regulatoryagency and/or customer needs warrant changes. Whenever significant changes are made to the formulation orprocess that may substantially affect the performance and/or safety of the condoms, these changes should beevaluated, validated and documented (e.g. changes in lubricant, changes in primary (individual) packaging
material, changes in leaching process).
Design validation should be used as the basis for ensuring that design parameters such as dimensions,
formulation, components, stability and shelf-life claims, packaging and dressing materials, etc., are appropriate.When appropriate or necessary, such as when there has been a significant change in the formulation, skin
irritation studies and safety evaluation should be performed and documented as part of design control activities.
Purchasers including procurement agencies, in addition to assuring that condoms comply with the ISO 4074,
should interact with manufacturers in specifying the parameters such as dimensions, type and amount oflubricant, type of packing, configuration of secondary and tertiary packaging, specific labelling, etc. The shape,
colour and additional features, if any, should also be stated by the procurement agency and agreed upon with
the manufacturer. Any additional specifications should be communicated to the testing laboratories also so thatthe correct specifications are applied while testing the products.
4.2 Clinical investigation
Since condoms are medical devices, it may be appropriate to carry out clinical trials when significant changesare made to the design, type of lubricant, etc. rather than relying on laboratory data. Clinical trials may also beconducted to compare specific characteristics of different products. These characteristics might includedonning, slippage and breakage studies, and other parameters that could affect the efficacy and safety of the
condoms. Clinical trials should be conducted under a written protocol, to monitor the objectives clearly stated in
accordance with ISO 14155-1 and ISO 14155-2. Due consideration should be given to the inclusion ofappropriate reference condoms. The risk analysis should be carried out as specified in ISO 14971. ISO 16037is a guidance document that recommends physical parameters that should be measured before conductingclinical trials.
4.3 Risk management
4.3.1 Risk analysis and risk management
The manufacturers should carry out risk analysis as specified in ISO 14971 and make the analysis report
available to purchasers and regulatory agencies upon request. Any claims of additional features should have
definite substantiated performance and safety data should be duly documented (e.g. extra-strength condoms).
As an important component of risk management, the manufacturer needs to inform the user, through labelling,of any properties of the product or substances contained in it that may cause irritation, sensitization or allergicreaction. Guidelines for labelling have been set by several regional and national regulatory authorities and alsospecified in ISO 4074. Attention should be given to right choice of colours and additives, which are approved byregulatory agencies or certified to be safe for use in human beings. The consumer should be advised of
potential of latex allergy in rare cases.
4.3.2 Latex allergy
Condoms release smaller amounts of protein than latex gloves as they have thinner films and have shorter
duration of usage. However latex condom manufacturers should strive to keep the latex-protein level minimal.Control of extractable proteins is a quality management issue, and the manufacturer needs to know about and
control the content and release of allergenic substances, such as extractable proteins, by appropriate process
steps and controls; the process steps and controls should be part of the manufacturer's quality managementsystem. The methods for determining protein levels in latex gloves are given in EN 455-3 and ASTMD5712-99These methods may be adapted to determine protein levels in condoms. Protein levels may also be determinedby the ELISA method given in ASTMD6499-03.ISO 16038:2005(E)
© ISO 2005 –All rights reserved 34.3.3 Bioburden
Although condoms are non-sterile medical devices, care should be taken during manufacturing operations, to
minimize microbiological contamination, particularly specific pathogens which affect the skin and mucosa, forexample various species of pseudomonas, streptococcus, staphylococcus and 
E. coli. The potential causes of
contamination should be identified, controlled and monitored through the quality management system.
Biological evaluation can also be carried out using the test method specified in ISO 10993-1. 
5 Quality of manufacture
5.1 Quality management
The principle behind quality management is that quality cannot be achieved effectively and consistently throughend product testing alone. Rather, it needs to be built into every stage of the process and related activities thathave direct impact on the quality of the product. The manufacturer should apply the requirements of ISO 9001,ISO 13485 or other similar standards as the basis for quality management system and for its GoodManufacturing Practices for medical devices. These documents help to put into operation the principles of
quality management in the design and manufacture of products, and are generally required and emphasized for
production of health-related products throughout the world. They ensure that products are manufactured withclear and appropriate quality objectives and require that the quality management systems of manufacturers aresubject to regular audits to ensure the effectiveness and continual improvement of the systems. Procurementagencies and regulatory bodies should encourage and support manufacturers who implement a qualitymanagement system as described above.
5.2 Lot testing (finished-product testing)
Manufacturers should establish appropriate procedures to ensure that each lot complies with requirements ofISO 4074 and any additional requirements agreed with the purchaser. Manufacturers may test every lot orestablish appropriate statistical control procedures to ensure compliance. Because testing is destructive, testsshall be conducted on samples drawn according to ISO 2859-1 or equivalent. Sampling plans and compliancelevels are given in ISO 4074 and these need to be incorporated into the manufacturers' quality systems. While
applying the sampling plan, it should be emphasized that switching rules as specified in ISO 2859-1 should be
implemented to offer necessary customer protection. Manufacturers are advised to improve their productionfacilities to the stage where they can establish more stringent internal compliance levels than those in ISO 4074,to maximize acceptance by purchasers and third-party testing laboratories. Trends in lot quality can be used bymanufacturers to monitor their quality, and to give early warning that corrective action is needed to keep theproduct quality within acceptable limits. Regulatory authorities and large purchasers can also examine trends
and long-term performance of suppliers to get a better assessment of the quality of product supplied by
particular manufacturers. Manufacturers are advised to establish more stringent internal compliance levels tomaximize yields. Trends in lot quality can be used by manufacturers or purchasers to further assess the qualitymanagement of the individual manufacturer. Regulatory agencies and purchasers may employ certified oraccredited third party laboratories for testing lots of products in addition to periodic audits of manufacturer'squality management system.
In cases of dispute where manufacturers and purchasers have agreed to retest a lot, it is recommended the
appropriate sampling plans given in Annex B of ISO 4074:2002 or an alternate plan be used.
5.3 Rounding-off values
The results obtained during testing of samples are to be rounded off as given in relevant sections of ISO 4074.Where not specified in ISO 4074, follow the rounding-off rules specified in ISO 31-0:1992, Annex B.
6 Quality in procurement
While procuring condoms, the institutional purchasers should define the specifications for condoms consideringthe population to which the condoms are sold or distributed. It is necessary for the procurement agencies toISO 16038:2005(E)
4 © ISO 2005 –All rights reservedvalidate the source from which condoms are procured by pre-qualification assessment, by periodic audit of the
facilities and quality management system by an auditor familiar with condom manufacturing and type testing of
samples.
Traceability of the materials and the process used in manufacture of condoms is important and should be
implemented and monitored as required by ISO 13485, as part of manufacturer's quality management systems.
If condoms are to be purchased from a distributor rather than a manufacturer, it should be ensured that there is
traceability of product to the manufacturer and that there is traceability within the manufacturer's productionsystems. While selecting the sources, the quality and reliability of manufacturers should be reviewed withadditional weight given to manufacturers who exceed the basic requirements of ISO 4074 by addressingadditional measures such as implementation of quality managements, and special issues such as stability ofproducts, safety of products, control of bioburden, etc. The reliability of manufacturers should also be assessed
further on the basis of continuous supplies confirmed by end product testing and adherence to delivery
schedule, price and technical support services rendered by the manufacturers. The objective of ensuringundisrupted timely supply of quality condoms can be achieved only by selecting the right sources followed bycontinuous monitoring of supplies from those sources in addition to end product testing. The results of lot by lottesting should be monitored for each manufacturer. Any dispute in lot-by-lot testing should be reviewedconsidering all the relevant aspects and making use of advice as outlined in a document by WHO publication
[5].
Appropriate design and packaging specifications should be obtained while procuring condoms, considering the
need of population and logistics of procurement, promotion, storage, handling and distribution. Due attentionshould be given for storage of condoms in cool places adequately protected from other deleterious weatherconditions, direct heat, sunlight and mechanical damage. It is necessary to ensure that condoms are procuredwith shelf life claims duly supported by stability data and manage distribution in such a way that the stocks are
utilized well before their expiry date, by effective inventory management. Batch identification and traceability are
important aspects of quality management systems, which are relevant during handling, storage and distributionof condoms.
While procuring condoms, marginal issues on specifications and disputes on testing should be handled on the
basis of technical expertise and guidelines, rather than by mere administrative provisions. The purchaser should
seek advice from technical experts on condoms and make a balanced decision weighing the risks andavailability of safe and reliable condoms.
NOTE The WHO offers a helpline service.
7 Quality in testing
In procurement of condoms and regulatory monitoring, third party laboratories are widely used. Third partylaboratories should be selected on the basis of their having certified quality management system (e.g.ISO 9001) or by their being accredited in accordance with ISO/IEC 17025 by a recognized body. Sincecompliance testing of condoms based on ISO 4074 requires reliable detection of low levels of defectives testedby attributes (e.g. 0,25 AQL) based on sampling plans specified in ISO 2859-1, the performance of laboratories
should be suitably monitored by interlaboratory testing and calibration programmes. The third party test
laboratories should have adequate expertise in implementing intricacies of sampling plans as elaborated inISO 2859-1. The monitoring of third party laboratories by procurement agencies should be based on periodicaudits and review of interlaboratory test programs. Accredited laboratories are periodically audited by nationalaccreditation agencies.
8 Important parameters to be considered when using ISO 4074
8.1 Size
There is evidence that in different parts of the world, different condom sizes are needed. There appears to be aneed for providing a range of sizes. A condom that is too small may cause problems in unrolling; one that is toolarge may slip off during use. The range of comfortable fit for any given size will also depend upon the propertiesand shape of the particular condom design. Any increase in the number of sizes would complicate productionand increase costs. Some new sizes may have a market too small to be economical. Regulatory authorities orISO 16038:2005(E)
© ISO 2005 –All rights reserved 5buyers need to be aware of the appropriate size(s) for their user populations. If they believe that different sizes
are needed, appropriate studies would help to establish confidence in the need for additional sizes.
8.2 Resistance to breakage
It is necessary that condoms have sufficient elasticity and mechanical strength. The determination of burst
volume and pressure by inflation of air provides a reasonable measure of the quality and consistency of thecondom. Tests for tensile properties also measure stress and strain. However, claims such as “extra strong “
should not be assumed to offer higher level of protection against breakage, unless substantiated by clinicaldata. The breakage of condoms may also be caused by improper use and inadequate lubricity in use. Theclinical data should substantiate a statistically significant reduction in breakage rate for the extra strong condom
when compared to a reference, marketed condom from normal production produced by the same manufacturer.
The reference condom should comply with the requirements of ISO4074 and should exceed  singlewall thickness at mid-body.
8.3 Compatibility of materials
Oil-based “lubricants ” often are easily available to users but should not be used with condoms. They degrade
the latex film so quickly that the condom may fail during the period of normal use. This issue is dealt withinISO 4074 in the relevant section on labelling. The compatibility of the topical drugs used in the vagina with
condoms cannot be assumed, and drug manufacturers should be encouraged to do compatibility tests.
Additional lubricants, when used should be carefully chosen (see 8.7). Materials used in the manufacture ofcondoms including the foiling and packaging, should be proven to be compatible with the product by appropriateassessments during design and manufacturing stages.
8.4 Shelf-life and resistance to degradation
It needs to be established by design control, that condoms will have adequate resistance to degradation duringthe claimed shelf life. Incorporation of suitable antioxidants and preservatives in the formulation, using metal-based foil laminates with excellent barrier properties and labelling instructions detailing proper storage
conditions will ensure protection during storage. These aspects should be validated at the design stage,
monitored during manufacture and confirmed by type testing, when required.
Shelf-life considerations of condoms are important for ensuring that the physical, performance and safety
aspects of condoms are met throughout the claimed period. Only condoms properly formulated, suitablyprocessed and packaged will be able to meet the specifications during shelf life. The quantity and nature of
antioxidant, vulcanizing chemicals and stabilizers are all critical in conferring the requisite shelf life. The
condoms tend to undergo degradation by oxidation and decomposition of rubber polymer units. The condomsneed to be stored protected from light, heat and mechanical damage so that the properties are not affected.Therefore it is recommended to protect the condoms by packing them in oxygen- and ozone-impermeablematerials such as aluminium-foil laminates and to protect them from light-catalysed degradation reactions.
Shelf-life claims should be substantiated by well-designed stability studies, in accordance with Clause7 of
ISO 4074:2002. Shelf life should be determined by real time studies at .
Clause 7 of ISO 4074:2002 defines the minimum stability requirement that needs to be complied with before
any new product for which there has been a significant change to formulation or process can be marketed. Even
though this requirement does not correlate with any specified shelf life, it has been included in the standard
essentially as a safeguard.
Since it is impracticable to complete real-time ageing studies before introducing products to the market,
accelerated stability studies based on kinetic principles can be used to assign a provisional shelf life. Such
provisional shelf lives assigned should be verified by real-time studies.
Manufacturers should carry out accelerated stability studies to predict shelf life. Such predicted shelf-life claims
should be supported by real-time data. Methods for accelerated stability studies are based upon models thatcan predict the outcome of real-time ageing studies. There is no single method that has been sufficiently0,060mm
(30+5
−2)◦CISO 16038:2005(E)
6 © ISO 2005 –All rights reservedvalidated or widely used to justify its designation as a standard method. Accelerated stability studies can be
conducted by the methods described and referred to in Annex K of ISO 4074:2002 (which is not fully validated
at the date of publication of this guidance document) or by other methods acceptable to the relevant regulatoryauthorities. Manufacturers who have historical real-time data on many different products are able to performcomparative tests between old and new products. Comparing accelerated test results of the new products withknown ageing data, accelerated as well as real time, allows these manufacturers to determine the estimatedshelf life for the new products.
The selection of temperatures (refer to Technical Corrigendum to ISO 4074:2002) and time periods for
accelerated stability studies needs to be made with caution as the application of this technique has only limitedexperience.
Manufacturers not having an extensive historical database and third party testers cannot rely on these methods
and therefore may use methods based on kinetic models.
Given the limited experience of estimating shelf lives by applying these techniques, ISO 4074 currently specifies
that shelf life claims should not exceed five years.
The following example illustrates the application of the time-temperature superposition technique described in
Annex K of ISO 4074:2002 to accelerated ageing data obtained for a condom that has a poor reputation for
ageing in real time. This method has not yet been demonstrated to be fully applicable for all types of condomsand is currently being reviewed by the relevant working group of ISO/TC 157.
EXAMPLE Time-temperature superposition plots were constructed from the accelerated ageing data according to the
procedure described in Annex K of ISO 4074:2002. A value of  for the activation energy and a reference
temperature of  were used to calculate the Arrhenius shift factors. The time-temperature superposition plot for bursting
pressure times volume ( ) is shown in Figure1. It can be seen that a reasonable degree of superposition has been
obtained. The value of  after any proposed storage time can be estimated with a reasonable degree of confidence
from this plot. For example, after 2 years at  the value of  will drop to approximately .
Figures 2 and 3, however, show that there is a poor degree of superposition for the pressure and volume
curves. Nevertheless the following general trends can be seen.
—The rate of decline in burst pressure versus transformed time reduces as the ageing temperature is lowered.
This trend indicates that the burst pressure will be fairly stable at .
—The rate of decline in burst volume versus transformed time increases as the ageing temperature is
lowered. This trend suggests that burst volume changes will be more significant at .
From Figure2 it can be concluded that after 2 years at , the burst pressure will be in the order of 
to . Given that the estimated value for the product of burst  after 2years is , the burstvolume will therefore be approximately . This value is fully consistent with the trend shown in Figure 3. Witha burst volume of , taken together the distribution of burst volumes normally seen with this condom,compliance with the requirements of Clause 6 after 2 years at  is unlikely. We can conclude therefore that
the shelf life of these condoms will be limited to approximately 2years at .
The Arrhenius shift factor between  and  for an activation energy of 83 kJ/mol is 7,7. Therefore the
shelf life estimate can be confirmed by conditioning samples of the condom at  for 13,5 weeks(2years/7,7) and assessing compliance with the burst property requirements defined in Clause 6. With thisparticular condom, it is clear that burst volume changes are more significant than burst pressure changes at
lower temperatures. Studies to confirm shelf life should therefore be conducted at lower temperatures, such as
, rather than at high temperatures.
The data on stability testing shall be maintained as part of quality systems documentation and should be made
available to regulatory agencies and purchasers when requested.83kJ/mol
30◦C
p×V
p×V
30◦C p×V 50kPa ·l
30◦C
30◦C
30◦C 2,2kPa
2,3kPa p×V 50kPa ·l
22l
22l
30◦C
30◦C
30◦C5 0◦C
50◦C
50◦CISO 16038:2005(E)
© ISO 2005 –All rights reserved 7Key
X  (burst pressure  volume, 
Y time at  (weeks)
Figure1 —Burst pressure times volume versus time transformed to p×V × kPa×l
30◦C
30◦CISO 16038:2005(E)
8 © ISO 2005 –All rights reservedKey
X burst pressure, 
Y time at  (weeks)
Figure2 —Burst pressure versus time transformed to kPa
30◦C
30◦CISO 16038:2005(E)
© ISO 2005 –All rights reserved 98.5 Packaging and labelling
The packaging materials chosen should give the condoms appropriate protection from damage due to
oxidation, UV-light, moisture, environmental contamination and mechanical damage during shipping, storage
and handling. Labelling requirements are specified in Clause11 of ISO 4074:2002 and can be supplementedwith special requirements of the purchaser and the regulatory agencies of each country.
8.6 Type testing
Type testing as referenced in Clause7 of ISO 4074:2002 is used to establish the shelf life of the product. Datasupporting the shelf life claim should be made available to regulatory bodies and purchasers on request. Typetesting as referred to in ISO 4074 should not be confused with type test and type examination proceduresrequired by some regulatory authorities, purchasers and validation procedures. Whenever there is anysignificant change to the formulation or process, the manufacturer should perform a new type test.
Examples of significant changes are change or addition of any new process chemical, change in packaging
material for individually sealed containers, change in the leaching agent, dressing materials and type of
lubricant.
Any changes in the formulation or process within previously validated ranges are not significant. The sample
sizes and the tests to be carried out for type testing are specified in AnnexB of ISO 4074:2002.Key
Xb u r s t  v o l u m e
Y time at  (weeks)
Figure3 —Burst volume versus time transformed to 30◦C
30◦CISO 16038:2005(E)
10 © ISO 2005 –All rights reserved8.7 Lubricants
The lubricants used with the condom should be safe and compatible with rubber and chemicals used in
formulation. The amount of lubricant is agreed upon by purchaser and is controlled as part of design control.
There are also condoms with lubricants containing spermicides and microbiocides, e.g. nonoxynol-9. Such
lubricant attributes should be documented as part of design control.
9 Sampling
Condoms are medical devices and thus the manufacturer and the buyer need to understand sampling and setthe parameters for acceptable quality. There is an absolute need to meet or exceed the minimum quality limitsgiven in ISO 4074 and have an effective quality management system. The manufacturer can use anyappropriate system to meet its quality objectives, but the sampling scheme set out in ISO 4074 and ISO 2859-1are recommended when a lot is tested by a third party for compliance or for any other type of certificationscheme. The use of smaller sample sizes can lead to a false assessment of the lot. It is of utmost importance
that the samples are drawn randomly from the whole lot and randomised further before testing.ISO 16038:2005(E)
© ISO 2005 –All rights reserved 11Bibliography
[1] ISO/TR 8550, Guide for the selection of an acceptance sampling system, scheme or plan for inspection of
discrete items in lots
[2] ISO/TR 13425, Guidelines for the selection of statistical methods in standardization and specification
[3] ISO 2859-0, Sampling procedures for inspection by attributes — Part0: Introduction to the ISO 2859
attribute sampling system
[4] ISO/TR 16142, Medical devices — Guidance on the selection of standards in support of recognized
essential principles of safety and performance of medical devices
[5] WHO: Compendium on male latex condom
[6] ISO 9001:2000, Quality management systems — Requirements
[7] ISO 10993-1, Biological evaluation of medical devices — Part1: Evaluation and testing
[8] ISO 13485:2003, Medical devices — Quality management systems — Requirements for regulatory
purposes
[9] ISO 14971:2000, Medical devices — Application of risk management to medical devices
[10] ISO 16037:2002, Rubber condoms for clinical trials — Measurement of physical properties
[11] ISO/IEC 17025, General requirements for the competence of testing and calibration laboratories
[12] EN 455-3, Medical gloves for single use — Part 3: Requirements and testing for biological evaluation
[13]  ASTM D5712-99, Standard test method for the analysis of aqueous extractable protein in natural rubber
and its products using the modified Lowry method
[14] ASTM D6499-03, Standard test method for the immunological measurement of antigenic protein in
natural rubber and its products
[15] BARKER,L.R. J. Nat. Rubb. Res ., 2 (4), 1987, pp. 210-213
[16] BARKER,L.R. J. Nat. Rubb. Res ., 5 (4), 1990, pp. 266-274
[17] G ILLEN,K.T. et al. ISO/TC 157 WG 13 document, reference not given
[18] M ANDEL, J. et al. J. Res. Nat. Bur. Stand ., 63C, 2, Oct - Dec 1959
[19] G RIMM,W . Drug Dev. And. Ind. Pharm ., 19 (20), 1993, pp. 2795-2830
[20] PANNIKOTTU , A. and K ARMARKAR ,U . Elastomer Service Life Prediction Symposium  ‘99, E.J. Thomas Hall,
University of AkronISO 16038:2005(E)
ICS 11.200
Price based on 11 pages
© ISO 2005 –All rights reserved