ISO 29942:2011
(Main)Prophylactic dams — Requirements and test methods
Prophylactic dams — Requirements and test methods
ISO 29942:2011 specifies the minimum requirements and test methods for prophylactic dams used to assist in the prevention of sexually transmitted infections.
Membranes prophylactiques — Exigences et méthodes d'essai
General Information
Standards Content (Sample)
INTERNATIONAL ISO
STANDARD 29942
First edition
2011-07-01
Prophylactic dams — Requirements and
test methods
Membranes prophylactiques — Exigences et méthodes d'essai
Reference number
ISO 29942:2011(E)
©
ISO 2011
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ISO 29942:2011(E)
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ISO 29942:2011(E)
Contents Page
Foreword .iv
Introduction.v
1 Scope.1
2 Normative references.1
3 Terms and definitions .2
4 Quality verification .3
5 Design.4
6 Barrier properties .5
7 Biocompatibility.5
8 Surface finish.5
9 Tensile properties.5
10 Tests for stability and shelf-life .6
11 Freedom from holes.7
12 Visible defects .7
13 Packaging and labelling.7
14 Data sheets .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.11
Annex B (normative) Sampling plans intended for assessing compliance of isolated lots .12
Annex C (normative) Determination of length and width .13
Annex D (normative) Determination of dam thickness.14
Annex E (informative) Guidance for risk assessment.15
Annex F (normative) Determination of barrier properties using the bacteriophage method .17
Annex G (normative) Determination of tensile properties.21
Annex H (normative) Oven conditioning.22
Annex I (normative) Determination of shelf-life by real-time stability studies.23
Annex J (informative) Guidance on conducting and analysing accelerated ageing studies.25
Annex K (normative) Testing for holes.27
Bibliography.29
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ISO 29942:2011(E)
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 29942 was prepared by Technical Committee ISO/TC 157, Non-systemic contraceptives and STI barrier
prophylactics.
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ISO 29942:2011(E)
Introduction
A prophylactic dam is used to cover parts of the human body during sexual contact. The prophylactic dam
(hereinafter also referred to as “dam”) provides coverage to the external female genitalia or the anal area.
Non-porous, intact, polymer films have been demonstrated as barriers to the human immunodeficiency virus
(HIV) and other infectious agents responsible for the transmission of sexually transmitted infections (STls). To
be effective, it is essential that dams be free from holes and defects, have adequate physical properties so as
not to break during use, be correctly packaged to protect them during storage and be correctly labelled to
facilitate their use.
To be safe, it is essential that the dam and additive, dressing, individual packaging material or powder applied
to it neither contain nor liberate substances in amounts that are toxic, sensitizing, locally irritating or otherwise
harmful under normal conditions of storage or use.
Prophylactic dams are non-sterile medical devices; however, a clean environment is essential to minimize
microbiological and particulate contamination of the product during manufacturing and packaging. To ensure a
high-quality product, it is essential that it be designed and produced under a good quality management
system. See ISO 13485 and ISO 14971 for more details on risk management and quality management.
It is intended that manufacturers conduct stability tests to estimate the shelf-life of any new or modified design
before the product is placed on the market. These tests 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, test laboratories and purchasers. They are also intended to limit
the need for third parties to conduct long-term stability studies. Real-time shelf-life studies are also initiated,
but not necessarily completed, prior to placing the product on the market.
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INTERNATIONAL STANDARD ISO 29942:2011(E)
Prophylactic dams — Requirements and test methods
1 Scope
This International Standard specifies the minimum requirements and test methods for prophylactic dams used
to assist in the prevention of sexually transmitted infections.
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 34-1, Rubber, vulcanized or thermoplastic — Determination of tear strength — Part 1: Trouser, angle and
crescent test pieces
ISO 37, Rubber, vulcanized or thermoplastic — Determination of tensile stress-strain properties
ISO 188, Rubber, vulcanized or thermoplastic — Accelerated ageing and heat resistance tests
ISO 2859-1:1999, Sampling procedures for inspection by attributes — Part 1: Sampling schemes indexed by
acceptance quality limit (AQL) for lot-by-lot inspection
ISO 4074, Natural latex rubber condoms — Requirements and test methods
ISO/TR 8550-1, Guidance on the selection and usage of acceptance sampling systems for inspection of
discrete items in lots — Part 1: Acceptance sampling
ISO/TR 8550-2, Guidance on the selection and usage of acceptance sampling systems for inspection of
discrete items in lots — Part 2: Sampling by attributes
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 10993-11, Biological evaluation of medical devices — Part 11: Tests for systemic toxicity
ISO 13485, Medical devices — Quality management systems — Requirements for regulatory purposes
ISO 14971, Medical devices — Application of risk management to medical devices
ISO 15223 (all parts), Medical devices — Symbols to be used with medical device labels, labelling and
information to be supplied
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ISO 29942:2011(E)
3 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 2859-1:1999, definition 3.1.26]
3.2
consumer package
package intended for distribution to a consumer, containing one or more individual containers of prophylactic
dams
3.3
date of manufacture
date of formation of the prophylactic dam
3.4
expiry date
date after which the prophylactic dam cannot be used
3.5
prophylactic dam
piece of polymer film that prevents the transmission of micro-organisms, which can cause sexually transmitted
infections, and is designed to cover the anal area and/or the external female genitalia
3.6
identification number
number, or combination of numerals, symbols or letters used by a manufacturer on consumer packages to
uniquely identify the lot numbers of individual prophylactic dams contained in that package, and from which it
is possible to trace those lots through all stages of manufacturing, packaging and distribution
NOTE Whenever the consumer package contains only one kind of prophylactic dam, the identification number can be
the same as the lot number. However, if the consumer package contains several different types of prophylactic dam, for
instance prophylactic dams of different shapes or colours, the identification number is different from the lot numbers.
3.7
individual container
primary package containing a prophylactic dam
3.8
inspection level
relationship between lot size and sample size
NOTE For a description, see ISO 2859-1:1999, 10.1.
3.9
lot
collection of dams 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
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. Attention is drawn to the difficulties that can be associated with the distribution and control of
very large lots. The recommended maximum individual lot size for production is 500 000.
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ISO 29942:2011(E)
3.10
lot number
number or combination of numerals, symbols or letters used by the manufacturer to identify a lot of individually
packaged dams, and from which it is possible to trace that lot through all stages of manufacture up to
packaging
3.11
lot test
test to assess the conformity of a lot
NOTE A lot test can be limited to include only those parameters that can change from lot to lot.
3.12
non-visible hole
hole in a dam that is not visible under normal or corrected vision, but is detected by a suitable water leak test
3.13
sampling plan
specific plan that 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)
3.14
shelf-life
period of time from the date of manufacture over which the product is claimed to conform to the specified
requirements
3.15
visible hole
hole in the dam that is visible under normal or corrected vision before the dam is exposed to water during
testing for holes
3.16
visible defect
〈other than hole〉 permanent crease with adhesion of the film, or other materials embedded in the film
4 Quality verification
Dams are produced in large quantities. Inevitably there is some variation between individual prophylactic
dams. A small proportion of dams in each production run might not meet the requirements of this International
Standard. Furthermore, 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. Sampling plans referred to in this
International Standard are identified in ISO 2859-1. Refer to ISO/TR 8550-1 for guidance on acceptance
sampling in general, and to ISO/TR 8550-2 for the selection of alternative acceptance sampling systems, for
the inspection of discrete items in a lot. For testing purposes, sampling shall be conducted by lot number, not
by identification number. Handling and storage conditions shall be documented before drawing the samples.
Sampling plans shall be selected to provide an acceptable level of consumer protection. Suitable sampling
plans are given in Annexes A and B.
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 cannot offer 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 applicable whenever five or more lots
are being tested.
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ISO 29942:2011(E)
Annex B describes sampling plans, based on ISO 2859-1, which are recommended for the assessment of
isolated lots. It is recommended that these sampling plans be 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 dams to be tested. The
lot size varies between manufacturers and is regarded as part of the process and quality controls used by the
manufacturer.
Where initial or ongoing quality verification for dams is required, it is suggested that, instead of concentrating
solely on evaluation of the final product, the party concerned also assess the manufacturer's quality system.
ISO 13485 specifies the provision of an integrated quality system.
5 Design
5.1 General
A prophylactic dam is a piece of polymer film that is used to prevent transmission of micro-organisms, which
can cause STIs. It is intended to cover the anal area or the external female genitalia. Dams shall be designed
to prevent STIs during sexual activity.
5.2 Dressing materials
The dam may be coated with dressing materials intended to protect it in storage, or with flavours or perfumes.
Any dressing material used shall be non-cytotoxic, non-sensitizing and non-irritating, respectively, and suitable
for human consumption. The dressing material shall not have any deleterious effects on the barrier
membrane.
5.3 Dimensions
5.3.1 Length
The length of a dam shall be between 200 mm and 350 mm. When tested in accordance with the method
given in Annex C, taking 13 dams from each lot, no measurement shall be outside the specified range.
5.3.2 Width
The width of a dam shall be between 150 mm and 250 mm. When tested in accordance with the method given
in Annex C, taking 13 dams from each lot, no measurement shall be outside the specified range.
5.3.3 Thickness
Whenever measured in accordance with Annex D, the mean thickness of the dam shall be not more than
0,15 mm. No single reading shall be below 75 % of the mean and no single reading shall be above 125 % of
the mean.
For dams made from natural rubber latex, no single thickness measurement shall be less than 0,04 mm.
5.4 Risk assessment
5.4.1 A risk assessment for the product shall be conducted in accordance with ISO 14971. The assessment
shall identify potential failure modes for the device as well as any other safety and efficacy concerns.
Manufacturers shall make the results of the risk assessment for the design, as described in Annex E, available
to regulatory authorities on request.
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ISO 29942:2011(E)
5.4.2 The manufacturer shall identify and define all reasonably predictable failure modes during the
analysis, and these failure modes shall be considered part of the design of the device.
6 Barrier properties
This clause applies only to products made from materials other than natural rubber latex.
The barrier properties of the dam shall be established by viral penetration studies using a suitable surrogate
virus, for example bacteriophage phi-X 174. Where tested in accordance with the method given in Annex F,
viral penetration properties shall be compared with those of a hole-free male latex condom that meets the
requirements of ISO 4074.
The viral penetration per unit area shall be no more than 150 % of the penetration found for the control dam.
7 Biocompatibility
Biocompatibility for the finished product and its components shall be established in accordance with
ISO 10993-1. Since the dam is in repeated contact with surface mucosa and possibly compromised tissue
surfaces, the testing shall be conducted to demonstrate that the materials are not cytotoxic and do not cause
sensitization, mucosal irritation or acute systemic toxicity, in accordance with the relevant clauses of
ISO 10993-1, ISO 10993-5, ISO 10993-10 and ISO 10993-11, respectively. If there is a likelihood of systemic
absorption of any components or residuals, mutagenicity testing shall be performed. All data generated in
these evaluations shall be made available to regulatory authorities on request.
The manufacturer shall also obtain, and make available to regulatory authorities on request, toxicity data on all
the additives and residual monomers, solvents and known impurities used in the manufacture of the dam
subject to this International Standard. Suitable material safety data sheets shall be supplied on request for
materials used in the manufacture of products conforming to this International Standard.
NOTE Attention is drawn to provisions in ISO 10993-1 that do not require specific tests on the product, provided it is
made from materials whose biocompatibility is already established.
8 Surface finish
Place the barrier membrane (dam) on a light box and examine under normal or corrected vision. The latex
barrier membrane should have a smooth surface finish on both sides. It shall be free from ingrained particles,
blisters, air bubbles and other imperfections, which would detract from its serviceability.
9 Tensile properties
9.1 Natural rubber latex dams
9.1.1 Tensile strength and elongation
Where tested in accordance with the method specified in Annex G using type 1, type 1A or type 2 dumb-bell
test pieces, the minimum tensile strength and elongation at break shall comply with the requirements given in
Table 1.
NOTE type 1A dumb-bells are preferable, if available.
9.1.2 Tear resistance
Where tested both longitudinally and transversely in accordance with ISO 34-1, method A (trouser tear test),
the minimum value of the tearing force (the force at the onset of tearing) and tear resistance shall comply with
the requirements of Table 1.
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ISO 29942:2011(E)
Table 1 — Minimum tensile properties and tear resistance
Tensile property Minimum requirements
Tensile strength, MPa 21
Elongation at break, % 650
Tear resistance, N/mm 5
Tearing force, N 0,5
An AQL of 2,5 shall apply.
9.2 Dams made from other materials
9.2.1 General
As part of the risk assessment in 5.4, the manufacturer shall determine suitable minimum values for the
tensile strength, elongation at break, tear resistance and tearing force, and make these values publicly
available as part of the device specification. Where the material used is already commonly used for other
products and its physical properties are published, the minimum values shall be at least similar to the
published properties of the material.
9.2.2 Tensile properties
Where tested in accordance with the method specified in Annex G using type 1, type 1A or type 2 dumb-bell
test pieces, the minimum tensile strength and elongation at break shall comply with the minimum values
developed by the manufacturer. An AQL of 2,5 shall apply to these values.
9.2.3 Tear resistance
Where tested both longitudinally and transversely in accordance with ISO 34-1, method A (trouser tear test),
the minimum value of the tearing force (the force at the onset of tearing) and tear resistance shall comply with
the requirements developed by the manufacturer. An AQL of 2,5 shall apply to these values.
10 Tests for stability and shelf-life
10.1 General
Manufacturers shall verify that the dams satisfy the requirements for freedom from holes, visible defects,
tensile strength and tear resistance given in Clauses 9 and 11 until the end of the labelled shelf-life. Shelf-life
claims shall not exceed five years.
Data supporting the shelf-life claims made by the manufacturer shall be made available to the appropriate
regulatory authorities and direct purchasers upon request.
Before a new or modified prophylactic dam design is placed on the market, the following requirements shall be
met:
a) the dam shall be tested for the minimum stability requirements as described in 10.2;
b) a real-time stability study, as described in 10.3, to determine shelf-life shall have commenced;
c) pending completion of the real-time stability study, shelf-life shall be estimated as described in 10.4.
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ISO 29942:2011(E)
10.2 Minimum stability requirements
Three lots of dams shall be tested for conformity to Clauses 9 and 11 using the sampling plans given in
Annex B. Only lots meeting all these requirements shall be used for the remainder of this test.
Condition samples in their individual containers in accordance with Annex H, one set for (168 ± 5) h
(one week) at (70 ± 2) °C and the other set for (90 ± 1) days at (50 ± 2) °C. At the end of the oven
conditioning, withdraw the prophylactic dams and test for tensile and tear properties in accordance with
Annex G and the requirements of 9.1 and 9.2.
NOTE Data used to verify compliance with 10.2 can be extracted from studies for estimates of shelf-life (see 10.4).
10.3 Procedure for determining shelf-life by real-time stability studies
After testing in accordance with Annex I, the dams shall meet the requirements of Clauses 9 and 11.
If the real-time data indicate a shorter shelf-life than that claimed on the basis of accelerated ageing
(see 10.4), the manufacturer shall notify the relevant regulatory authorities and direct purchasers. The
manufacturer shall change the shelf-life claim for the product to one based on the real-time stability study. In
no case shall shelf-life exceed five years. For prophylactic dams placed on the market, real-time stability
studies shall be completed for the full period of the shelf-life claim.
If the dams, as supplied to the consumer, are packed in a transparent pack, exposing the dam to light, then
the real-time stability study shall also expose the dams to light at a level and duration similar to what could be
expected in storage.
10.4 Estimating shelf-life based on accelerated stability studies
Pending the completion of real-time stability studies, accelerated stability studies shall be used to estimate the
+5
provisional shelf-life. Shelf-life estimates shall be based on a mean kinetic temperature of ( 30 ) °C for all
−2
climatic conditions and may be carried out on prophylactic dams from the same production lots as used for
real-time determination of shelf-life.
For dams made from natural rubber latex, conditioning at (50 ± 2) °C for 90 days may be taken as equivalent
to two years at (30 ± 2) °C, conditioning at (50 ± 2) °C for 120 days may be taken as equivalent to three years
at (30 ± 2) °C and conditioning (50 ± 2) °C for 180 days may be taken as equivalent to five years at
(30 ± 2) °C, for the purpose of establishing provisional shelf-life.
11 Freedom from holes
Where dams are tested for freedom from holes in accordance with the method described in Annex K, the AQL
and inspection level established in Annexes A and B shall apply. An AQL of 0,25 shall apply to this test.
12 Visible defects
Where dams are tested for visible defects as described in Annex K, the AQL and inspection level established
in Annexes A and B shall apply. An AQL of 1,0 shall apply to this test.
13 Packaging and labelling
13.1 Packaging
Each dam shall be packed in a container. One or more individual containers may be packed in other
packaging, such as a consumer package. Except as provided in this subclause, the individual container or
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ISO 29942:2011(E)
consumer package, or both, shall be opaque to light. Except as outlined in this subclause, the packaging shall
protect the dam from light even if only the individual package is provided to the consumer. If dams are
intended to be supplied only in individual containers, the individual containers shall be opaque.
Transparent packaging may be used if the manufacturer is able to supply data demonstrating that the
product's appearance and tensile properties are not adversely affected by continuous exposure to white
visible light at an incident intensity of 500 lx for one third of the shelf-life, or if exposure to daylight was
simulated during the real-time shelf-life study.
While the devices are not intended to be sterile, packing shall be conducted under clean conditions, with
suitable hygiene precautions enforced.
If a marking medium, such as ink, is used on a dam or on any part of a package directly in contact with a
prophylactic dam, it shall not have any deleterious effect on the dam or be harmful to the user.
Individual containers and any other packaging shall protect the dam from damage during normal
transportation and storage.
Individual containers and any other packaging shall be designed in such a way that the pack can be opened
without damaging the prophylactic dam. The design of the individual container should facilitate easy opening.
13.2 Labelling
NOTE National regulations can apply in certain jurisdictions in relation to labelling for latex allergy, etc.
13.2.1 Symbols
If symbols are used on packaging, information and marketing materials, th
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