ISO 29942:2011

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 2011
©  ISO 2011
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Published in Switzerland
ii © ISO 2011 – All rights reserved

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

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.
iv © ISO 2011 – All rights reserved

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.
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
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.
2 © ISO 2011 – All rights reserved

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.
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.
4 © ISO 2011 – All rights reserved

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.
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.
6 © ISO 2011 – All rights reserved

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
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, the symbols shall meet the
requirements of ISO 15223 (all parts).
13.2.2 Individual containers
Each individual container shall be legibly and indelibly marked with at least the following information:
a) the identity of the manufacturer and/or distributor;
b) the manufacturer's identifying reference for traceability (e.g. the lot number);
c) the expiry date (year and month). The format of the year shall be in four digits; the format of the month
shall be in letters or two digits.
13.2.3 Consumer packages
13.2.3.1 General
The outside of the consumer package shall bear at least the following information in at least one of the official
language(s) of the country of destination or as stipulated differently by that country:
a) a description of the dam;
b) the number of dams contained;
c) the size designation, if that manufacturer makes more than one size, the name or trade name, country of
manufacture and name and address of distributor, subject to national and regional requirements;
d) the expiry date (year and month). The format of the year shall be in four digits and the format of the
month shall be in letters or two digits. If a consumer package includes prophylactic dams from different
lots, the earliest expiry date shall apply to all prophylactic dams;
8 © ISO 2011 – All rights reserved

e) a statement of appropriate storage conditions for the dam materials;
f) if appropriate, a statement that individual containers, if not opaque to light, shall not be stored outside the
opaque consumer package;
g) when a medicinal ingredient is added, it shall be identified and its purpose indicated (e.g. spermicidal). If
the prophylactic dam is fragranced or flavoured, this shall be stated;
h) the manufacturer's identifying reference for traceability (e.g. the identification number/lot number). If
different types of dams, e.g. different colours, are packaged together in the same consumer package, the
identification number on the consumer package shall allow the manufacturer to identify uniquely the lot
numbers of the individual prophylactic dams contained in that package, so that it is possible to trace lots
through all stages of manufacture up to packaging;
i) a statement for dams made from natural rubber latex (NRL) that indicates that the dam contains natural
rubber and draws attention to the risks of latex allergy.
13.2.3.2 Additional information for the consumer
The outside or the inside of the consumer package, or a leaflet contained within the consumer package, shall
bear at least the following information expressed in simple terms, and in at least one of the official languages
of the country of destination. If possible, this should also be supplemented by pictorial representations of the
major steps involved or as stipulated differently by that country.
Instructions for use of the dam, including:
a) the need to handle the dam carefully, including removal from the package so as to avoid damage to the
dam by fingernails, jewellery, etc.;
b) how and when to place and hold the dam;
c) if an additional lubricant is desired, a statement instructing the user to use only the correct type of
lubricant which is recommended. If the dam is made from natural rubber latex, also include a statement
instructing the user to avoid the use of oil-based lubricants, such as petroleum jelly, baby oil, body lotions,
massage oils, butter, margarine, as these are deleterious to the integrity of the material;
d) a statement instructing the user to consult a doctor or pharmacist about the compatibility of topical
medicines that might come in contact with the dam;
e) a statement that the prophylactic dam is for single use;
f) the reference number of this International Standard, i.e. ISO 29942:2011.
13.3 Inspection
When inspected, 13 consumer packages and 13 individual containers shall be selected from each lot and
examined for conformity to 13.1, 13.2 and 13.3. All inspected containers shall conform to these requirements.
Under certain conditions, it may be permissible for the manufacturer/distributor to correct faults associated
with packaging and labelling requirements and resubmit the lot for further conformity testing. Examples
include the insertion of missing instruction leaflets or re-packaging of individual containers into new complete
consumer packages before placing on the market.
If dams from the same lot are packed into different consumer packages, at least one consumer package of
each variant should be inspected. The number of packages inspected should not exceed 13, unless the
number of variants exceeds 13.
14 Data sheets
The manufacturer shall make available to all interested parties a data sheet that contains, for each product
variant, at least the following information:
a) specifications for length, width and thickness;
b) specifications for amount and type of dressing materials (e.g. flavour, powder);
c) list of materials used in the product;
d) if the dam is made from materials other than natural latex rubber, the minimum tensile and tear
properties.
10 © ISO 2011 – All rights reserved

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
If a party wishes to establish, by inspection and testing of samples of the final product, whether a continuing
series of lots are in compliance with the requirements of this International Standard, the sampling plans and
acceptance criteria given in Table A.1 shall be applied.
Manufacturers may use the schemes in Table A.1 or they may devise and implement validated alternative
quality control methods that result in at least equivalent consumer protection.
When tests are being conducted on fewer than five lots of prophylactic dams, the additional protection of the
switching rules in ISO 2859-1 is not available and it is recommended that the sampling plans given in Annex B
be used to maintain the level of consumer protection.
Table A.1 — Sampling plans and acceptance criteria for a continuing series of lots
a
Attribute Acceptance criterion
Inspection level
Dimensions 13 dams All samples shall fall within the specified
limits
Tensile and tear properties 13 samples AQL of 2,5
Package integrity Special inspection level S-3 AQL of 2,5
Freedom from holes General inspection level I AQL of 0,25
Visible defects General inspection level I AQL of 1,0
Packaging and labelling 13 consumer packages and 13 individual All shall comply
containers
a
See ISO 2859-1 where relevant.

Applications for these sampling plans include the following:
a) ongoing production testing and quality control by a manufacturer;
b) ongoing testing by a purchaser for contractual purposes;
c) ongoing inspection by a regulatory or certification authority.
Annex B
(normative)
Sampling plans intended for assessing compliance of isolated lots
Use of the sampling plans given in Annex A for small numbers of lots, i.e. fewer than five, results in a higher
level of consumer risk because the switching rules are not available. In such circumstances, the use of larger
sample sizes is recommended in order to maintain an acceptable level of consumer protection. The choice of
a suitable sampling plan is governed by cost considerations. Larger sample sizes give better discrimination,
but at increased cost. Purchasers may, for example, rely upon their experience with a particular supplier when
assessing the sample sizes to use for small numbers of lots.
The sampling plans given in Table B.1 for normal inspection, where applied to isolated lots, provide
approximately the same level of consumer protection as those given in Annex A when used in conjunction
with the switching rules. Attention is drawn to the possibility of using double or multiple sampling plans, which
can reduce the total number of dams that need to be tested to demonstrate compliance when quality is
significantly better than the AQLs.
NOTE There is no simple mathematical relationship between the sample size and the lot size. Sample sizes can be
increased independently of the lot size to achieve a more reliable estimate of lot quality.
Table B.1 — Sampling plans and acceptance criteria for isolated lots
a
Attribute Acceptance criterion
Inspection level
Dimensions 13 dams All samples shall fall within the
manufacturer's specified limits
Tensile and tear properties Special inspection level S-3 but at least 32 samples AQL of 2,5
Package integrity Special inspection level S-3 but at least code letter H AQL of 2,5
Freedom from holes General inspection level I but at least code letter N AQL of 0,25
Visible defects General inspection level I but at least code letter N AQL of 1,0
Packaging and labelling 13 consumer packages and 13 individual containers All shall comply
a
See ISO 2859-1 where relevant.

Applications for these sampling plans can include the following:
a) type testing as part of a certification procedure;
b) cases where the total number of lots being assessed is insufficient to allow the switching rules to be
effective;
c) cases of dispute involving isolated lots, e.g. for referee testing.
12 © ISO 2011 – All rights reserved

Annex C
(normative)
Determination of length and width
C.1 Principle
The length and width of the dam are measured using a ruler.
C.2 Apparatus
C.2.1 Ruler, graduated in millimetres.
C.3 Procedure
Lay the barrier membrane (dam) flat on a flat surface. Measure the length and width of the barrier membrane
(dam) using the ruler.
C.4 Expression of results
Report the length and width of each tested dam to the nearest millimetre.
Annex D
(normative)
Determination of dam thickness
D.1 Principle
The thickness is measured with the use of a micrometer dial gauge.
D.2 Apparatus
D.2.1 Micrometer, dial or digital type, with resolution 0,001 mm, foot diameter between 3 mm and 10 mm,
and foot pressure at (22 ± 4) kPa, parallel to a flat base plate.
D.3 Method
Using the micrometer dial gauge, take nine thickness measurements in total, near each corner, near the
midpoint of each side and in the centre.
D.4 Test results
Report the mean and range of the results.
14 © ISO 2011 – All rights reserved

Annex E
(informative)
Guidance for risk assessment
E.1 General
A risk assessment identifies and estimates the seriousness of potential hazards associated with the use of the
prophylactic dam and helps determine whether these risks are acceptable.
E.2 Background
E.2.1 ISO 14971 provides a full reference to risk assessment as a component of risk management.
E.2.2 The risk assessment is intended to provide pre-production risk analysis and evaluation, not risk
control or post-production information.
E.3 Risk assessment process
E.3.1 The manufacturer should describe the intended use/intended purpose of the dam.
a) The intended use/intended purpose of the dam is based on the device specifications, instructions and all
other information provided by the manufacturer.
b) The intended use includes any reasonably foreseeable misuse of the product.
E.3.2 The manufacturer compiles a list of known or foreseeable hazards associated with the dam in both
normal and fault conditions. Reasonably foreseeable sequences of events that can result in a hazard situation
should be included.
E.3.3 The risks in both normal and fault conditions are then estimated based upon:
a) the probability of the occurrence of harm;
b) the consequences (e.g. severity) of that harm;
c) the likelihood that the hazard can be identified before a risk situation occurs.
Risks should be estimated using all available information or data. Where the probability of harm cannot be
estimated, a list of possible consequences of the hazard should be prepared.
E.3.4 There are a number of established techniques for the assessment of risk. These techniques are often
complementary and a manufacturer may choose to use more than one of these techniques. These techniques
are further described in ISO 14971. The techniques are
a) failure mode and effect analysis,
b) fault tree analysis, and
c) hazard and operating study.
E.3.5 For each identified hazard, the manufacturer decides for each hazard whether the estimated risk(s)
requires risk mitigation and controls.
E.4 Impact of risk assessment
Risk assessment is one component of a whole risk management system. If the result of the risk assessment is
that the risk(s) is/are not acceptable, the manufacturer should re-evaluate the design of the dam and/or
implement controls and mitigations as part of the risk management system.
If the result of the risk assessment is that the risk(s) is/are acceptable, the hazards and failures identified in
E.3.2 (above) shall be evaluated in accordance with ISO 14971.
16 © ISO 2011 – All rights reserved

Annex F
(normative)
Determination of barrier properties using the bacteriophage method
F.1 General
This annex provides the rationale, methodology and required sensitivity to test the ability of a dam to act as a
barrier to transmission of the etiological micro-organisms of STIs, including viruses. For latex dams that pass
the freedom from holes test, this determination is not required.
A dam is a medical device designed to prevent the transmission of micro-organisms that can cause STIs
during sexual intercourse. In order to make a claim that a dam is effective against STIs, appropriate laboratory
tests shall be performed. Since viruses are the smallest etiological STI agents, the challenge particle should
be a small virus or virus-size particle. The challenge particle, solution properties, test pressure and test
duration should be chosen to simulate, as closely as possible, real-use conditions. Choices of parameters that
make the in vitro test more stringent than expected real-use conditions are encouraged, with appropriate
justification. However, movement of the dam during the test is not required.
The choice of a challenge particle has several important aspects. Signal-to-noise ratio should be considered.
A biological ass
...