UGANDA STANDARD
 
       US ISO 16037 
First Edition
  2009- 09-04
 
Reference numbe r 
    US ISO 16037:2002
 © UNBS 2009
  
Rubber condoms for clinical trials — Measurement of physical 
properties 
 US ISO 16037:2002  
 
© 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: 256 414 505 995 
Fax: 256 414 286 123 
E-mail: unbs@infocom.co.ug
Web:  www.unbs.go.ug  
 US ISO 16037:2002 
© 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 Uganda.  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 16037:2002, Rubber condoms for clinical trials— Measurement of physical
properties,  is identical with and  has been reproduced from a International Standard, ISO 16037:2002,
Rubber condoms for clinical trials— Measurement of physical properties,  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
16037
First edition
2002-05-15
Reference number
ISO16037:2002(E)
© ISO2002Rubber condoms for clinical trials — 
Measurement of physical properties
Préservatifs masculins en caoutchouc destinés aux essais cliniques — 
Mesurage des propriétés physiques
                  
ISO 16037:2002(E)
ii © ISO 2002 –All rights reservedPDF disclaimer
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Printed in SwitzerlandISO 16037:2002(E)
© ISO 2002 – All rights reserved iiiForeword
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 technicalcommittees. Each member body interested in a subject for which a technical committee has been established hasthe right to be represented on that committee. International organizations, governmental and non-governmental, inliaison 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 3.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 International Standard may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights.
International Standard ISO 16037 was prepared by Technical Committee ISO/TC 157, Mechanical contraceptives .ISO 16037:2002(E)
iv © ISO 2002 –All rights reservedIntroduction
Clinical investigations of condoms involve many aspects, notably condom acceptability and failure. Useful studies
require many condoms and subjects, which are expensive. Clinical studies often underestimate the potentialinfluence of condom physical properties, whose laboratory testing is far less expensive. As physical properties mayvary over time and from product to product, a lack of brand- and lot-specific data may well reduce the usefulness ofa clinical investigation for improving condom quality and efficacy.
While some investigations may best be conducted using condoms of the participants' choice, it is usually appropriate
to ensure that all participants use condoms having the same physical characteristics. In most cases, each clinicalinvestigation will evaluate condoms of one or more types. Study condoms of each type should generally be from thesame lot, in order to ensure that they are characterized by the same physical properties. If special properties aredesired, independent test laboratories may be able to advise as to which laboratories or manufacturers should be
contacted for assistance.
In most situations determination of these characteristics should be part of the study design. Assistance in this regard
is available from a number of independent testing laboratories, and from some condom manufacturers. Laboratoriesshould be experienced in, and accredited for, condom testing, in accordance with recognized standards.
It is believed that gathering as much physical information as possible about the condoms used is a sensible
precaution. In principle, tests on physical properties should all be done at the beginning of the investigation, andsome should be repeated at the end. In investigations running over more than six months, additional tests may beconsidered during the investigation to give a profile of the change in physical properties over the duration of the study.
While there have been several clinical investigations on condom failure, relatively few of these fully identify the
physical characteristics of the condoms used. Thus, it is difficult to compare meaningfully the results of different
investigations, or to build hypotheses about design or manufacturing factors that may affect condom efficacy.
Having developed an International Standard on the requirements and test methods for natural latex rubber condoms,
(ISO 4074), ISO/TC 157 remains interested in further clinical validation of the physical requirements given, and inany data that may suggest a need for amendments to them. This document offers guidance on the measurement ofphysical properties characterizing condoms used in clinical investigations. Recommended sample sizes for
laboratory testing in this document are in some cases intentionally larger than those in ISO 4074.
This document is written primarily for investigations on natural rubber condoms, but the principles apply to condoms
of other materials also. It should not be expected that elongation properties of synthetic materials will be similar tothose of natural rubber.INTERNATIONAL STANDARD ISO 16037:2002(E)
© ISO 2002 – All rights reserved 1Rubber condoms for clinical trials — Measurement of physical 
properties
1 Scope
This International Standard is intended as a guideline for clinical researchers working with condoms. It suggests a
series of laboratory tests to be conducted on the products to be used in any clinical investigation, so that it will beeasier to relate the clinical results to the design and quality of the condoms used.
This International Standard is not applicable to the design of clinical investigations.
2 Normative references
The following normative documents contain provisions which, through reference in this text, constitute provisions of
this International Standard. For dated references, subsequent amendments to, or revisions of, any of thesepublications do not apply. However, parties to agreements based on this International Standard are encouraged toinvestigate the possibility of applying the most recent editions of the normative documents indicated below. Forundated references, the latest edition of the normative document referred to applies. Members of ISO and IECmaintain registers of currently valid International Standards.
ISO 37, Rubber, vulcanized or thermoplastic— Determination of tensile stress-strain properties
ISO 4074, Natural latex rubber condoms — Requirements and test methods
3 Terms and definitions
For the purposes of this International Standard, the terms and definitions given in ISO 4074 apply.
4 Length
4.1Measure and record the length of 13condoms per lot, as described in ISO 4074. Calculate lot mean length and
standard deviation (or confidence interval).
4.2The length and width of any teat (reservoir) should also be measured (see also 5.2 below).
5W i d t h
5.1Measure and record the flat width of 13condoms per lot, as described in ISO 4074, at sections every 
between  from the closed end and  from the open end (rim). For each section, calculate the lot meanwidth and standard deviation (or confidence interval).
5.2Alternatively, a profile of the condom may be constructed by photocopying cleaned, dusted and flattened
specimens alongside a transparent ruler.10mm
30mm 30mmISO 16037:2002(E)
2 © ISO 2002 –All rights reserved6 Thickness
6.1Determine the thickness of the condom in the transition area between the shaft of the condom and the reservoir
(or closed end if there is no reservoir).  Make this measurement as close as possible to the closed end, consistent
with being able to flatten the rubber film on the micrometer anvil without excessive stretching.
6.2Measure at least 13 condoms, using a micrometer dial gauge with a resolution of at least , a foot
diameter of  and foot pressure of . At each section, measure and record at least four
evenly spaced single wall thicknesses.
6.3Thickness may also be determined using the weighing method outlined in ISO 4074, on parallel-sided parts of
the condom. This may be useful if any comparisons are made with condoms tested for compliance using ISO 4074,
and a relationship between the two types of measurement is required.
Cut the test piece centred on the section concerned. Measure and record each test piece flat width to the nearest
 and mass to the nearest . Calculate the test piece thickness from the formula:
where
is the thickness, expressed in millimetres;
is the mass, expressed in milligrams;
is the width, expressed in millimetres.
NOTE There is a systematic difference between the direct measurement and weighing methods, the latter giving higher values
than the former.
7B e a d
From 13condoms per lot, remove the bead (rim) by scissors or tearing, and cut it open. Measure and record each
bead length (to the nearest ) and thickness at three sections (to the nearest ). Calculate the lot meanlength and thickness, with standard deviation (or confidence interval).
8 Air inflation properties
Inflate at least 315 condoms per lot (but preferably 500), as described in ISO 4074. Measure and record eachbursting pressure and volume. Data should be recorded to the maximum precision available from the equipment,rather than using the rounding specified in ISO 4074. Calculate lot mean bursting pressure and volume, withstandard deviations (or confidence intervals); and report the number of defectives (specimens visibly leaking air, orbursting under ISO 4074 minimum pressure and/or volume).
Data may be summarized as histograms (or stem-and-leaf diagrams). The aim of the test is not only to determine
whether the lot(s) of products being used in the investigation comply with ISO 4074, but also to reliably estimate themean, range, standard deviation, and number of non-compliers. For a more reliable estimate of lot defectiveness, atleast 2000condoms should be tested.
9 Tensile properties
9.1Cut mid-body test pieces as specified in ISO 4074 from 20condoms per lot. Measure and record for each test
piece either:
a) length (to the nearest ), and thickness at four points (to the nearest ), or 
b) flat width (to the nearest ) and mass (to the nearest ).0,010mm
(5±2)mm (22±4)kPa
0,5mm 1mg
t=0,0268 m/w
t
mw
1mm 0,01mm
0,5mm 0,001mm
0,5mm 1mgISO 16037:2002(E)
© ISO 2002 – All rights reserved 3Test the test-pieces on a tensile tester as specified in ISO 4074. Measure and record each test-piece force (to the
nearest ) at ,  and  elongation and at break, and the elongation at break (as percentage of
original length).
9.2Calculate lot mean elastic modulus at ,  and  elongation, breaking force and elongation
(strain), and tensile strength, with standard deviation (or confidence interval).
In case9.1 b), stresses and tensile strength may be calculated from:
where
is the stress, expressed in megapascals;is the tensile force at break, expressed in newtons;is the width, expressed in millimetres;is the mass, expressed in milligrams.
9.3For non-isotropic materials, the tensile properties shall also be determined along the long axis of the condom.
These tests shall be carried out using a dumbbell sample cut with an ISO Type I or Type II cutter as specified inISO 37. The width of the test piece (nominally ) may be taken to be the width of the throat of the cutter.Measure and record the thickness of each test piece (to the nearest ) at four points.
10 Lubricant
On 32 specimens per lot, measure and record the mass of lubricant (to the nearest ) in each individualcontainer, and that on each condom as removed from its individual container, using the method described inISO 4074. Calculate the lot mean mass of lubricant on the condom and in the individual container, with the standard
deviations (or confidence intervals).
11 Freedom from holes and visible defects
11.1Test at least 315condoms per lot for aqueous leakage, as described in ISO 4074 (specifying the method).
Record the number of specimens with holes (over  from the rim), and the distance from the closed end of any
hole detected, measured to the nearest .
11.2In the same sample, inspect each condom for visible defects (including holes). Record the number of visibly
defective specimens, and the location and nature of any visible defect.
11.3For a more reliable estimate of lot defectiveness, at least 2000condoms per lot should be tested for holes
and visible defects.
12 Information from manufacturer
The manufacturer should be informed of the clinical investigation, and asked for a full technical specification of the
condom type, including physical properties (as above), and data on stability (oven-treated and/or naturally aged
condom bursting and tensile properties), dressing materials (including any spermicidal lubricant), toxicity,allergenicity, etc.0,1N 100% 300% 600%
100% 300% 600%
σ=0,935F·w
m
σ
Fwm
20mm
0,001mm
10mg
25mm
1mmISO 16037:2002(E)
4 © ISO 2002 –All rights reserved13 Follow-up studies
Condoms should be sampled and tested at the beginning of their clinical investigation. If the clinical investigation
extends beyond six months, then air-inflation and tensile testing should be repeated every six months and at the endof the investigation. Re-tested condom sample sizes may be reduced appropriately.ISO 16037:2002(E)
© ISO 2002 – All rights reserved 5Bibliography
[1] ISO 10993-1, Biological evaluation of medical devices — Part 1: Evaluation and testing
[2] ISO 10993-10, Biological evaluation of medical devices — Part 10: Tests for irritation and delayed-type
hypersensitivity
[3] ISO 14155:1996, Clinical investigation of medical devices
[4] ISO 14971, Medical devices — Application of risk management to medical devicesISO 16037:2002(E)
ICS 11.200
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© ISO 2002 –All rights reserved