Female condoms -- Requirements and test methods

ISO 25841:2017 specifies the minimum requirements and test methods for female condoms that are supplied to consumers for contraceptive purposes and for assisting in the prevention of sexually transmitted infections (STIs).

Préservatifs féminins -- Exigences et méthodes d'essai

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Status
Published
Publication Date
13-Aug-2017
Current Stage
6060 - International Standard published
Start Date
14-Jul-2017
Completion Date
14-Aug-2017
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INTERNATIONAL ISO
STANDARD 25841
Third edition
2017-08
Female condoms — Requirements and
test methods
Préservatifs féminins — Exigences et méthodes d’essai
Reference number
ISO 25841:2017(E)
ISO 2017
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ISO 25841:2017(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2017, Published in Switzerland

All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form

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ii © ISO 2017 – All rights reserved
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ISO 25841:2017(E)
Contents Page

Foreword ..........................................................................................................................................................................................................................................v

Introduction ..............................................................................................................................................................................................................................vii

1 Scope ................................................................................................................................................................................................................................. 1

2 Normative references ...................................................................................................................................................................................... 1

3 Terms and definitions ..................................................................................................................................................................................... 1

4 Quality verification ............................................................................................................................................................................................ 5

5 Lot size ............................................................................................................................................................................................................................ 6

6 Design .............................................................................................................................................................................................................................. 6

6.1 General ........................................................................................................................................................................................................... 6

6.2 Product insertion feature ............................................................................................................................................................... 6

6.3 Retention features ................................................................................................................................................................................ 7

6.4 Lubrication ................................................................................................................................................................................................. 7

6.5 Dimensions ................................................................................................................................................................................................. 8

6.5.1 Length........................................................................................................................................................................................ 8

6.5.2 Width ......................................................................................................................................................................................... 8

6.5.3 Thickness ................................................................................................................................................................................ 8

6.6 Risk assessment ..................................................................................................................................................................................... 8

7 Barrier properties .............................................................................................................................................................................................. 9

8 Biocompatibility ................................................................................................................................................................................................... 9

9 Clinical (human use) investigations ................................................................................................................................................. 9

10 Microbial contamination...........................................................................................................................................................................10

11 Bursting volume and pressure ............................................................................................................................................................11

11.1 Minimum values..................................................................................................................................................................................11

11.2 Sampling and requirements .....................................................................................................................................................11

12 Tests for stability and shelf life ..........................................................................................................................................................12

12.1 General ........................................................................................................................................................................................................12

12.2 Procedure for determining shelf life by real-time stability studies .......................................................12

12.3 Procedure for estimating shelf life based upon accelerated stability studies ...............................12

13 Freedom from holes .......................................................................................................................................................................................13

14 Visible defects.......................................................................................................................................................................................................13

15 Packaging and labelling .............................................................................................................................................................................13

15.1 Individual container integrity .................................................................................................................................................13

15.2 Packaging ..................................................................................................................................................................................................13

15.3 Labelling ....................................................................................................................................................................................................14

15.3.1 Symbols .................................................................................................................................................................................14

15.3.2 Individual containers ................................................................................................................................................14

15.3.3 Consumer packages ........................................................................................................................................... .........14

15.3.4 Additional information for the consumer ...............................................................................................15

15.3.5 Female condoms not distributed in consumer packages...........................................................16

15.4 Inspection .................................................................................................................................................................................................16

16 Data sheets...............................................................................................................................................................................................................16

Annex A (normative) Sampling plans intended for assessing conformity of a continuing

series of lots of sufficient number to allow the switching rules to be applied ..................................18

Annex B (informative) Sampling plans intended for assessing conformity of isolated lots ....................19

Annex C (normative) Determination of lubricant mass for individual female condom containers 20

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ISO 25841:2017(E)

Annex D (normative) Determination of female condom length ...........................................................................................22

Annex E (normative) Determination of female condom width ..............................................................................................23

Annex F (normative) Determination of female condom thickness ....................................................................................24

Annex G (normative) Testing for female condom individual container integrity ..............................................26

Annex H (normative) Determination of barrier properties using the bacteriophage method ............28

Annex I (informative) Determination of microbial contamination ...................................................................................33

Annex J (normative) Determination of bursting volume and bursting pressure................................................38

Annex K (normative) Testing for holes ...........................................................................................................................................................40

Annex L (normative) Determination of shelf life by real-time stability studies ..................................................48

Annex M (informative) Guidance on conducting and analysing accelerated ageing studies ..................50

Bibliography .............................................................................................................................................................................................................................53

iv © ISO 2017 – All rights reserved
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ISO 25841:2017(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.

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: w w w . i s o .org/ iso/ foreword .html.

This document was prepared by Technical Committee ISO/TC 157, Non-systemic contraceptives and STI

barrier prophylactics.

This third edition cancels and replaces the second edition (ISO 25841:2014) which has been technically

revised.
The modifications are as follows:
— clinical failure mode definitions have been harmonized with ISO 29943-2;

— tolerances have been specified for the amount of lubricant applied to the female condom and the

length, width and sheath thickness of the female condom. These tolerances are to be applied to the

nominal values specified by the manufacturers for these design features;

— manufacturers are required to specify female condom width and thickness at three locations along

the length of the female condom sheath;

— manufacturers are required to identify specifications and test methods as appropriate to verify

the design and to ensure the quality and consistency of components and materials used for the

retention features and any insertion feature used with the female condom;

— manufacturers are recommended to establish procedures for the periodic monitoring of microbial

contamination (bioburden) as part of their quality management system including requirements for

the absence of specific pathogens and limits for total viable counts on finished female condoms;

methods of determining bioburden levels on female condoms are given in Annex I;

— detailed changes have been made to the test methods for determining freedom from holes and

airburst properties to improve the reproducibility of female condom testing between laboratories

and accommodate female condoms made from a wider range of sheath materials including sheaths

made from natural rubber latex;

— a greater degree of harmonization with ISO 4074 has been achieved for common requirements and

definitions;
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ISO 25841:2017(E)

— for female condoms with sheaths made from natural rubber latex, reference is included in the

procedures for estimating provisional shelf lives from accelerated stability studies given in ISO 4074;

— the maximum lot size for female condoms has been limited to 500 000;
— labelling requirements have been revised and updated.
vi © ISO 2017 – All rights reserved
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ISO 25841:2017(E)
Introduction

A female condom is a sheath that completely lines the vaginal canal and is designed to be retained

in the vagina during sexual intercourse and after withdrawal of the penis to prevent pregnancy and

transmission of sexually transmitted infections (STIs).

A female condom is distinguished from a male condom in that it is retained in the vagina after withdrawal

of the penis. The external component of the device can provide some coverage to the external female

genitalia. Nonporous, intact, polymer films can be effective barriers to human immunodeficiency

virus (HIV), other infectious agents responsible for the transmission of STIs and spermatozoa. Female

condoms made from polymer films that are free from holes and defects, have adequate physical

properties so as not to break during use, are correctly packaged to protect them during storage and are

correctly labelled to facilitate their correct use, can be effective for contraceptive purposes and in the

prevention of sexually transmitted infections (STIs).

To be safe, it is essential that the female condom and any lubricant, 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.

Female condoms are non-sterile medical devices but manufacturers are advised to take appropriate

precautions to minimize microbiological contamination of the product during manufacture and

packaging. To ensure high quality products, it is essential that female condoms be designed and

produced under a good quality management system. Reference can be made, for example, to ISO 9000,

ISO 9004, ISO 9001, ISO 13485 and ISO 14971. To estimate the shelf life of any new or modified female

condom, the manufacturer conducts stability tests before the product is placed on the market. This

ensures that manufacturers have adequate data to support shelf-life claims 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.

Because female condoms are a relatively new class of device and designs of female condoms vary

considerably, clinical investigations in humans are necessary to continue to build evidence of safety

and efficacy. These investigations enable an assessment of the overall performance of internal and

external retention features, failure modes, safety and effectiveness of female condoms. This document

represents minimal requirements and test methods and acknowledges that new designs can require

further due rigour of retention and other features as well as additional definition of specifications and

test methods by the manufacturer.
All of these issues are addressed in this document.
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INTERNATIONAL STANDARD ISO 25841:2017(E)
Female condoms — Requirements and test methods
1 Scope

This document specifies the minimum requirements and test methods for female condoms that are

supplied to consumers for contraceptive purposes and for assisting in the prevention of sexually

transmitted infections (STIs).
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 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 rubber latex male condoms — Requirements and test methods

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 14155, Clinical investigation of medical devices for human subjects — Good clinical practice

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

ISO 29943-2, Female condoms — Guidance on the design, execution, analysis and interpretation of clinical

failure mode studies
3 Terms and definitions

For the purposes of this document, the terms and definitions given in ISO 2859-1 and the following apply.

ISO and IEC maintain terminological databases for use in standardization at the following addresses:

— IEC Electropedia: available at http:// www .electropedia .org/
— ISO Online browsing platform: available at http:// www .iso .org/ obp
3.1 General terms
3.1.1
acceptable quality limit
AQL

quality level that is the worst tolerable process average when a continuing series of lots (3.1.9) is

submitted for acceptance sampling
[SOURCE: ISO 2859-1:1999, 3.1.26]
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ISO 25841:2017(E)
3.1.2
consumer package

package intended for distribution to a consumer, containing one or more individual container(s) (3.1.7)

of female condom (3.1.5)
3.1.3
date of manufacture

date of formation of the female condom (3.1.5) sheath or the date the female condoms are packed in

their individual containers (3.1.7) provided, in the latter case, a maximum period of bulk storage is

specified and shelf-life studies have been conducted on female condoms that have been subjected to the

maximum bulk storage period
3.1.4
expiry date
date after which the female condom (3.1.5) should not be used
3.1.5
female condom

sheath that completely lines the vaginal canal and is designed to be retained in the vagina during sexual

intercourse and after withdrawal of the penis to prevent pregnancy and transmission of sexually

transmitted infections
3.1.6
identification number

number, or combination of numbers, symbols or letters used by a manufacturer on consumer packages

(3.1.2) to uniquely identify the lot numbers (3.1.10) of individual female condoms contained in that

package and from which it is possible to trace those lots (3.1.9) through all stages of manufacturing,

packaging and distribution

Note 1 to entry: When the consumer package contains only one kind of female condom, then the identification

number can be the same as the lot number. However, if the consumer package contains several different types of

female condoms, for instance, female condoms of different shapes or colours, then the identification number will

be different from the lot number.
3.1.7
individual container
primary package containing a single female condom (3.1.5)
3.1.8
inspection level

index of the relative amount of inspection of an acceptance sampling scheme, chosen in advance and

relating the sample size to the lot size
[SOURCE: ISO 3534-2:2006, 4.3.5]
3.1.9
lot

collection of female condoms (3.1.5) 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 (3.1.7)
3.1.10
lot number

number or combination of numerals, symbols or letters used by the manufacturer to identify a lot (3.1.9)

of individually packaged female condoms (3.1.5) and from which it is possible to trace that lot through

all stages of manufacture up to packaging
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ISO 25841:2017(E)
3.1.11
non-visible hole

hole in a female condom (3.1.5) that is not visible under normal or corrected vision but is detected by a

suitable water leakage test

Note 1 to entry: Leakage during testing can be detected, for instance, by rolling a female condom on

absorbent paper.
Note 2 to entry: Suitable tests are specified in this document.
3.1.12
sampling plan

specific plan which indicates the number of units of product from each lot (3.1.9) that 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)
3.1.13
shelf life

period from date of manufacture (3.1.3) to the claimed expiry date (3.1.4) during which female condoms

(3.1.5) are required to conform to the requirements for bursting pressure, bursting volume, freedom

from holes and package integrity specified in this document
3.1.14
visible hole

hole or tear in the female condom (3.1.5) that is visible under normal or corrected vision before the

condom is filled with water during the test for freedom from holes
3.1.15
visible defects

broken, missing or severely distorted retention features, permanent

crease with adhesion of the film or unintentional adhesion of the film to retention features including

defect particles from female condoms (3.1.5) or other materials embedded in the female condom wall

3.1.16
visible defects

empty, leaking, damaged or dirty containers, illegible or missing information

or absence of a notch or other device to facilitate opening the container without damaging the female

condom (3.1.5) or rendering illegible any important information printed on the container

Note 1 to entry: Important information includes lot number (3.1.10), expiry date (3.1.4) and any instructions for

use printed on the container.
3.2 Terms related to female condom failure modes
3.2.1
acute failure event

female condom (3.1.5) failure identified by the risk analysis conducted in accordance with ISO 14971

3.2.2
clinical breakage

female condom (3.1.5) breaks or tears during intercourse or withdrawal of the female condom from

the vagina

Note 1 to entry: This might not be noticed until after inspection of the female condom following intercourse.

3.2.3
clinical breakage rate

number of female condom (3.1.5) broken or torn during sexual intercourse or withdrawal divided by the

number of female condoms used during sexual intercourse
Note 1 to entry: Typically reported as a percentage.
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ISO 25841:2017(E)
3.2.4
non-clinical breakage

female condom (3.1.5) breakage that does not potentially expose the vagina to semen or other penile

discharge

Note 1 to entry: An example of a non-clinical breakage is tearing a female condom while opening the package.

3.2.5
non-clinical breakage rate

number of female condom (3.1.5) broken that do not potentially expose the vagina to semen or other

penile discharge divided by the number of female condom packages opened
Note 1 to entry: Typically reported as a percentage.
3.2.6
total breakage
sum of female condom clinical (3.2.2) and non-clinical breakages (3.2.4)
3.2.7
total breakage rate

number of clinical (3.2.2) and non-clinical breakages (3.2.4) divided by the number of female condom

packages opened
Note 1 to entry: Typically reported as a percentage.

Note 2 to entry: The total breakage rate will not be the sum of the clinical breakage rate (3.2.3) and the non-

clinical breakage rate (3.2.5). The clinical breakage rate has a different denominator than the other two rates.

3.2.8
clinical slippage

situation where the condom slips completely out of the vagina during sexual intercourse

3.2.9
clinical slippage rate

number of female condoms (3.1.5) that slipped divided by the number of female condoms used during

sexual intercourse
Note 1 to entry: Typically reported as a percentage.
3.2.10
clinical misdirection

situation where the penis is inserted between the female condom (3.1.5) and the vaginal wall

3.2.11
clinical misdirection rate

number of female condoms (3.1.5) that misdirect divided by the number of female condoms used during

sexual intercourse
Note 1 to entry: Typically reported as a percentage.
3.2.12
clinical invagination

external retention feature of the female condom (3.1.5) is partially or fully pushed into the vagina

during sexual intercourse
3.2.13
clinical invagination rate

number of female condoms (3.1.5) that invaginate divided by the number of female condoms used during

sexual intercourse
Note 1 to entry: Typically reported as a percentage.
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ISO 25841:2017(E)
3.2.14
total clinical failure

number of female condoms (3.1.5) with at least one acute failure event (3.2.1) that results in potential

vaginal exposure to semen and other penile discharge

Note 1 to entry: Any female condom which experiences multiple clinical failure events only counts as a single

clinical failure

Note 2 to entry: Includes female condoms with the following failures: clinical breakage (3.2.2), slippage (3.2.8),

misdirection (3.2.10), invagination (3.2.12) or any failure event(s) in the risk assessment as described in 6.6.

3.2.15
total clinical failure rate

number of female condoms (3.1.5) with clinical failure divided by the number of female condoms used

during sexual intercourse
Note 1 to entry: Typically reported as a percentage.
3.2.16
total female condom failure

female condom (3.1.5) with any type of clinical failure event or non-clinical failure event

3.2.17
total female condom failure rate

number of female condoms (3.1.5) with a clinical failure event or a non-clinical failure event divided by

the number of female condom packages opened
Note 1 to entry: Typically reported as a percentage.
4 Quality verification

Female condoms are mass-produced articles manufactured in large quantities. Inevitably, there will

be some variation between individual female condoms, and a small proportion of female condoms

...

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