ISO 19671:2018
(Main)Additional lubricants for male natural rubber latex condoms — Effect on condom strength
Additional lubricants for male natural rubber latex condoms — Effect on condom strength
This document specifies a method of assessing the effect or compatibility of an additional or personal lubricant with lubricated male natural rubber latex condoms. It also applies to topical medicines and any other substances that come into contact with such condoms. It describes the measurement of changes in physical properties of the condoms after exposure to the test substance (i.e. lubricant, topical medicine, etc.) and specifies the pass/fail criteria for such changes. This document is not applicable to the assessment of the compatibility of lubricants applied to a condom at the time of manufacture. It is not directly applicable to the assessment of the compatibility of a particular condom with lubricants or other substances. It is not directly applicable to tests using female condoms, although similar principles can apply. The test methods are applicable to condoms made from natural rubber latex and from synthetic materials, but a pass/fail criterion is only stipulated for natural rubber latex.
Lubrifiants supplémentaires pour préservatifs masculins en latex de caoutchouc naturel — Effet sur la résistance du préservatif
General Information
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INTERNATIONAL ISO
STANDARD 19671
First edition
2018-11
Corrected version
2020-02
Additional lubricants for male natural
rubber latex condoms — Effect on
condom strength
Lubrifiants supplémentaires pour préservatifs masculins en latex de
caoutchouc naturel — Effet sur la résistance du préservatif
Reference number
©
ISO 2018
© ISO 2018
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting
on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address
below or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Fax: +41 22 749 09 47
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2018 – All rights reserved
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Principle . 2
5 Apparatus . 2
6 Materials . 3
7 Samples and tests . 3
7.1 Sample overview . 3
7.2 Condom sample groups . 4
7.3 Sample size . 4
7.4 Quantity of test substance . 4
7.4.1 Inflation testing . 4
7.4.2 Tensile testing . 4
8 Procedure. 4
8.1 General . 4
8.2 (Negative) control testing . 5
8.3 Inflation testing . 5
8.4 Tensile testing . 5
9 Positive control testing . 6
10 Pass/Fail criteria . 6
11 Expression of results . 8
Annex A (normative) Determination of force and elongation at break of test pieces of condoms .9
Annex B (informative) Determination of the confidence interval for the ratio of two means.12
Bibliography .15
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www .iso .org/ directives).
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. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www .iso .org/ patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation on the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to the
World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see the following
URL: www .iso .org/ iso/ foreword .html.
This document was prepared by Technical Committee ISO/TC 157, Non-systemic contraceptives and STI
barrier prophylactics.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www .iso .org/ members .html.
This corrected version of ISO 19671:2018 incorporates the following corrections:
— specifications for viscosity and specific gravity of positive control in 6.2;
— specifications for viscosity and specific gravity of positive control in Clause 9;
— “test substance” has been replaced by “lubricant” in A.3.3;
— subscript in Formula (B.4).
iv © ISO 2018 – All rights reserved
Introduction
Weakening of natural rubber latex is known to occur after contact with certain lubricants, particularly
petroleum-based products. This procedure was developed as a screening method for lubricant
manufacturers to determine whether or not a particular personal lubricant or topical medicine has
a significant effect on the tensile and airburst properties of condoms. It is also applicable to topical
medicines and other chemicals that might come in contact with vulval, vaginal or rectal tissues, and
hence with condoms.
The method is designed for use on male condoms that meet the criteria of ISO 4074. While the test
method can be effective for male condoms made of other raw materials, there is no evidence upon
which to base pass/fail criteria for these materials.
This test method does not determine the safety of either the test substance or the condom.
This test method is to be used only to determine if the tensile or airburst properties of the condom have
been significantly affected by the test substance.
INTERNATIONAL STANDARD ISO 19671:2018(E)
Additional lubricants for male natural rubber latex
condoms — Effect on condom strength
1 Scope
This document specifies a method of assessing the effect or compatibility of an additional or personal
lubricant with lubricated male natural rubber latex condoms. It also applies to topical medicines
and any other substances that come into contact with such condoms. It describes the measurement
of changes in physical properties of the condoms after exposure to the test substance (i.e. lubricant,
topical medicine, etc.) and specifies the pass/fail criteria for such changes.
This document is not applicable to the assessment of the compatibility of lubricants applied to a condom
at the time of manufacture. It is not directly applicable to the assessment of the compatibility of a
particular condom with lubricants or other substances. It is not directly applicable to tests using female
condoms, although similar principles can apply.
The test methods are applicable to condoms made from natural rubber latex and from synthetic
materials, but a pass/fail criterion is only stipulated for natural rubber latex.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 4074:2015, Natural rubber latex male condoms — Requirements and test methods
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 4074 and the following apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at http:// www .electropedia .org/
3.1
personal lubricant
additional lubricant intended for application by the user at the time of condom use
3.2
positive control
test substance (3.3) which is known to cause deterioration in the physical properties of a condom
3.3
test substance
lubricant (3.1), topical medicine (3.4) or other material which is being tested for compatibility with
condoms
3.4
topical medicine
medicine intended to be used vaginally or rectally, and which might come into contact with a
condom in use
4 Principle
This test method measures the change in tensile properties and inflation properties of condoms, after
60 min of contact with a lubricant or other test substance to which this document refers. Force at break
is the principal and most sensitive variable used in assessing the effect of test substances.
For tensile testing, rings cut from condoms are exposed to the test substance, heated to body
temperature, cleaned of excess test substance, and tested for force at break and percent elongation at
break in accordance with Annex A. Those properties are compared to control rings that are subjected
to the same procedures using distilled water instead of the test substance.
For inflation testing, the parts of the condoms which are subject to inflation are exposed to the test
substance and are then heated to body temperature. They are then subjected to inflation testing as
prescribed in ISO 4074 or ISO 23409. The results are compared to control condoms that are subjected
to the same using distilled water instead of the test substance.
5 Apparatus
5.1 Environmental chamber or oven, capable of maintaining (40 ± 2) °C.
5.2 Specimen containers for inflation testing, capable of holding one condom and sealing volatile
components of the test substance, so they cannot escape into the atmosphere. The excess space in the
container should be kept to a minimum.
NOTE A glass jar is a suitable container.
5.3 Specimen containers for tensile testing, capable of holding one tensile sample and sealing
volatile components of the test substance, so they cannot escape into the atmosphere. The excess space
in the container should be kept to a minimum.
NOTE A glass jar is a suitable container.
5.4 Tensile tester and roller grips, capable of testing ring specimens according to Annex A.
5.5 Ring-cutting die, mechanical press, and replaceable cutting surface, for cutting ring specimens
from condoms, compliant with Annex A.
5.6 Mounts, suitable for holding r
...
INTERNATIONAL ISO
STANDARD 19671
First edition
2018-11
Corrected version
2020-02
Additional lubricants for male natural
rubber latex condoms — Effect on
condom strength
Lubrifiants supplémentaires pour préservatifs masculins en latex de
caoutchouc naturel — Effet sur la résistance du préservatif
Reference number
©
ISO 2018
© ISO 2018
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting
on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address
below or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Fax: +41 22 749 09 47
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2018 – All rights reserved
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Principle . 2
5 Apparatus . 2
6 Materials . 3
7 Samples and tests . 3
7.1 Sample overview . 3
7.2 Condom sample groups . 4
7.3 Sample size . 4
7.4 Quantity of test substance . 4
7.4.1 Inflation testing . 4
7.4.2 Tensile testing . 4
8 Procedure. 4
8.1 General . 4
8.2 (Negative) control testing . 5
8.3 Inflation testing . 5
8.4 Tensile testing . 5
9 Positive control testing . 6
10 Pass/Fail criteria . 6
11 Expression of results . 8
Annex A (normative) Determination of force and elongation at break of test pieces of condoms .9
Annex B (informative) Determination of the confidence interval for the ratio of two means.12
Bibliography .15
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www .iso .org/ directives).
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. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www .iso .org/ patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation on the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to the
World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see the following
URL: www .iso .org/ iso/ foreword .html.
This document was prepared by Technical Committee ISO/TC 157, Non-systemic contraceptives and STI
barrier prophylactics.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www .iso .org/ members .html.
This corrected version of ISO 19671:2018 incorporates the following corrections:
— specifications for viscosity and specific gravity of positive control in 6.2;
— specifications for viscosity and specific gravity of positive control in Clause 9;
— “test substance” has been replaced by “lubricant” in A.3.3;
— subscript in Formula (B.4).
iv © ISO 2018 – All rights reserved
Introduction
Weakening of natural rubber latex is known to occur after contact with certain lubricants, particularly
petroleum-based products. This procedure was developed as a screening method for lubricant
manufacturers to determine whether or not a particular personal lubricant or topical medicine has
a significant effect on the tensile and airburst properties of condoms. It is also applicable to topical
medicines and other chemicals that might come in contact with vulval, vaginal or rectal tissues, and
hence with condoms.
The method is designed for use on male condoms that meet the criteria of ISO 4074. While the test
method can be effective for male condoms made of other raw materials, there is no evidence upon
which to base pass/fail criteria for these materials.
This test method does not determine the safety of either the test substance or the condom.
This test method is to be used only to determine if the tensile or airburst properties of the condom have
been significantly affected by the test substance.
INTERNATIONAL STANDARD ISO 19671:2018(E)
Additional lubricants for male natural rubber latex
condoms — Effect on condom strength
1 Scope
This document specifies a method of assessing the effect or compatibility of an additional or personal
lubricant with lubricated male natural rubber latex condoms. It also applies to topical medicines
and any other substances that come into contact with such condoms. It describes the measurement
of changes in physical properties of the condoms after exposure to the test substance (i.e. lubricant,
topical medicine, etc.) and specifies the pass/fail criteria for such changes.
This document is not applicable to the assessment of the compatibility of lubricants applied to a condom
at the time of manufacture. It is not directly applicable to the assessment of the compatibility of a
particular condom with lubricants or other substances. It is not directly applicable to tests using female
condoms, although similar principles can apply.
The test methods are applicable to condoms made from natural rubber latex and from synthetic
materials, but a pass/fail criterion is only stipulated for natural rubber latex.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 4074:2015, Natural rubber latex male condoms — Requirements and test methods
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 4074 and the following apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at http:// www .electropedia .org/
3.1
personal lubricant
additional lubricant intended for application by the user at the time of condom use
3.2
positive control
test substance (3.3) which is known to cause deterioration in the physical properties of a condom
3.3
test substance
lubricant (3.1), topical medicine (3.4) or other material which is being tested for compatibility with
condoms
3.4
topical medicine
medicine intended to be used vaginally or rectally, and which might come into contact with a
condom in use
4 Principle
This test method measures the change in tensile properties and inflation properties of condoms, after
60 min of contact with a lubricant or other test substance to which this document refers. Force at break
is the principal and most sensitive variable used in assessing the effect of test substances.
For tensile testing, rings cut from condoms are exposed to the test substance, heated to body
temperature, cleaned of excess test substance, and tested for force at break and percent elongation at
break in accordance with Annex A. Those properties are compared to control rings that are subjected
to the same procedures using distilled water instead of the test substance.
For inflation testing, the parts of the condoms which are subject to inflation are exposed to the test
substance and are then heated to body temperature. They are then subjected to inflation testing as
prescribed in ISO 4074 or ISO 23409. The results are compared to control condoms that are subjected
to the same using distilled water instead of the test substance.
5 Apparatus
5.1 Environmental chamber or oven, capable of maintaining (40 ± 2) °C.
5.2 Specimen containers for inflation testing, capable of holding one condom and sealing volatile
components of the test substance, so they cannot escape into the atmosphere. The excess space in the
container should be kept to a minimum.
NOTE A glass jar is a suitable container.
5.3 Specimen containers for tensile testing, capable of holding one tensile sample and sealing
volatile components of the test substance, so they cannot escape into the atmosphere. The excess space
in the container should be kept to a minimum.
NOTE A glass jar is a suitable container.
5.4 Tensile tester and roller grips, capable of testing ring specimens according to Annex A.
5.5 Ring-cutting die, mechanical press, and replaceable cutting surface, for cutting ring specimens
from condoms, compliant with Annex A.
5.6 Mounts, suitable for holding r
...
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