oSIST prEN ISO 4074:2010
(Main)Natural rubber latex condoms - Requirements and test methods (ISO/DIS 4074:2010)
Natural rubber latex condoms - Requirements and test methods (ISO/DIS 4074:2010)
2011-03-18 EMA: WI deleted as equivalent ISO Project cancelled in January 2011.
Kondome aus Naturkautschuklatex - Anforderungen und Prüfverfahren (ISO/DIS 4074:2010)
Diese Internationale Norm legt die anzuwendenden Mindestanforderungen und Prüfverfahren für aus
Naturkautschuklatex hergestellte Kondome für Männer fest, die zur Empfängnisverhütung und zur
Unterstützung des Schutzes gegen sexuell übertragbare Infektionen verwendet werden.
Préservatifs masculins en latex de caoutchouc naturel - Exigences et méthodes d'essai (ISO/DIS 4074:2010)
Kondomi iz naravnega kavčuka - Zahteve in preskusne metode (ISO/DIS 4074:2010)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
oSIST prEN ISO 4074:2009
01-september-2009
.RQGRPLL]QDUDYQHJDNDYþXND=DKWHYHLQSUHVNXVQHPHWRGH ,62',6
Natural rubber latex condoms - Requirements and test methods (ISO/DIS 4074:2009)
Kondome aus Naturkautschuklatex - Anforderungen und Prüfverfahren (ISO/DIS
4074:2009)
Préservatifs masculins en latex de caoutchouc naturel - Exigences et méthodes d'essai
(ISO/DIS 4074:2009)
Ta slovenski standard je istoveten z: prEN ISO 4074
ICS:
11.200 1DþUWRYDQMHGUXåLQH Birth control. Mechanical
0HKDQVNLNRQWUDFHSFLMVNL contraceptives
SULSRPRþNL
oSIST prEN ISO 4074:2009 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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oSIST prEN ISO 4074:2009
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oSIST prEN ISO 4074:2009
EUROPEAN STANDARD
DRAFT
prEN ISO 4074
NORME EUROPÉENNE
EUROPÄISCHE NORM
June 2009
ICS 11.200 Will supersede EN ISO 4074:2002
English Version
Natural rubber latex condoms - Requirements and test methods
(ISO/DIS 4074:2009)
Préservatifs masculins en latex de caoutchouc naturel - Kondome aus Naturkautschuklatex - Anforderungen und
Exigences et méthodes d'essai (ISO/DIS 4074:2009) Prüfverfahren (ISO/DIS 4074:2009)
This draft European Standard is submitted to CEN members for parallel enquiry. It has been drawn up by the Technical Committee
CEN/TC 205.
If this draft becomes a European Standard, CEN members are bound to comply with the CEN/CENELEC Internal Regulations which
stipulate the conditions for giving this European Standard the status of a national standard without any alteration.
This draft European Standard was established by CEN in three official versions (English, French, German). A version in any other language
made by translation under the responsibility of a CEN member into its own language and notified to the CEN Management Centre has the
same status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
Recipients of this draft are invited to submit, with their comments, notification of any relevant patent rights of which they are aware and to
provide supporting documentation.
Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without notice and
shall not be referred to as a European Standard.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2009 CEN All rights of exploitation in any form and by any means reserved Ref. No. prEN ISO 4074:2009: E
worldwide for CEN national Members.
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oSIST prEN ISO 4074:2009
prEN ISO 4074:2009 (E)
Contents Page
Foreword .3
2
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oSIST prEN ISO 4074:2009
prEN ISO 4074:2009 (E)
Foreword
This document (prEN ISO 4074:2009) has been prepared by Technical Committee ISO/TC 157 "Mechanical
contraceptives" in collaboration with Technical Committee CEN/TC 205 “Non-active medical devices” the
secretariat of which is held by DIN.
This document is currently submitted to the parallel Enquiry.
This document will supersede EN ISO 4074:2002.
This document has been prepared under a mandate given to CEN by the European Commission and the
European Free Trade Association, and supports essential requirements of EC Directive(s).
Endorsement notice
The text of ISO/DIS 4074:2009 has been approved by CEN as a prEN ISO 4074:2009 without any
modification.
3
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oSIST prEN ISO 4074:2009
DRAFT INTERNATIONAL STANDARD ISO/DIS 4074
ISO/TC 157 Secretariat: DSM
Voting begins on: Voting terminates on:
2009-06-04 2009-11-04
INTERNATIONAL ORGANIZATION FOR STANDARDIZATION • МЕЖДУНАРОДНАЯ ОРГАНИЗАЦИЯ ПО СТАНДАРТИЗАЦИИ • ORGANISATION INTERNATIONALE DE NORMALISATION
Natural rubber latex condoms — Requirements and test
methods
Préservatifs masculins en latex de caoutchouc naturel — Exigences et méthodes d'essai
(Revision of first edition ISO 4074:2002 and ISO 4074:2002/Cor 1:2003)
ICS 11.200
ISO/CEN PARALLEL PROCESSING
This draft has been developed within the International Organization for Standardization (ISO), and
processed under the ISO-lead mode of collaboration as defined in the Vienna Agreement.
This draft is hereby submitted to the ISO member bodies and to the CEN member bodies for a parallel
five-month enquiry.
Should this draft be accepted, a final draft, established on the basis of comments received, will be
submitted to a parallel two-month approval vote in ISO and formal vote in CEN.
To expedite distribution, this document is circulated as received from the committee secretariat.
ISO Central Secretariat work of editing and text composition will be undertaken at publication
stage.
Pour accélérer la distribution, le présent document est distribué tel qu'il est parvenu du
secrétariat du comité. Le travail de rédaction et de composition de texte sera effectué au
Secrétariat central de l'ISO au stade de publication.
THIS DOCUMENT IS A DRAFT CIRCULATED FOR COMMENT AND APPROVAL. IT IS THEREFORE SUBJECT TO CHANGE AND MAY NOT BE
REFERRED TO AS AN INTERNATIONAL STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS BEING ACCEPTABLE FOR INDUSTRIAL, TECHNOLOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT
INTERNATIONAL STANDARDS MAY ON OCCASION HAVE TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN NATIONAL REGULATIONS.
RECIPIENTS OF THIS DRAFT ARE INVITED TO SUBMIT, WITH THEIR COMMENTS, NOTIFICATION OF ANY RELEVANT PATENT RIGHTS OF WHICH
THEY ARE AWARE AND TO PROVIDE SUPPORTING DOCUMENTATION.
©
International Organization for Standardization, 2009
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oSIST prEN ISO 4074:2009
ISO/DIS 4074
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©
ii ISO 2009 – All rights reserved
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ISO/DIS 4074
Contents Page
Introduction.v
1 Scope.1
2 Normative references.1
3 Terms and definitions .1
4 Quality verification .3
5 Biocompatibility.4
6 Lot size .4
7 Product claims.4
8 Design.4
9 Burst volume and pressure.5
10 Stability and shelf life.5
11 Freedom from holes.6
12 Visible defects .6
13 Package integrity of individual container .7
14 Packaging and labelling.7
15 Test report.9
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 (informative) Sampling plans intended for assessing compliance of isolated lots .13
Annex C (normative) Determination of total lubricant for condoms in individual containers.14
Annex D (normative) Determination of length .16
Annex E (normative) Method for the determination of width.18
Annex F (normative) Determination of thickness.19
Annex G (normative) Determination of bursting volume and pressure.21
Annex H (normative) Oven treatment for condoms .24
Annex I (informative) Determination of force and elongation at break of test pieces of condoms.25
Annex J (normative) Determination of shelf life by real-time stability studies .27
Annex K (informative) Guidance on conducting and analysing accelerated ageing studies .29
Annex L (normative) Testing for holes.31
Annex M (normative) Tests for package integrity .37
Annex N (informative) Calibration of air inflation equipment for determination of burst volume and
pressure .39
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ISO/DIS 4074
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 4074 was prepared by Technical Committee ISO/TC 157, Mechanical Contraceptives.
This second edition cancels and replaces the first edition (ISO 4074:2002), of which has been technically
revised.
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ISO/DIS 4074
Introduction
The intact latex film has been shown to be a barrier to human immunodeficiency virus (HIV), other infectious
agents responsible for the transmission of sexually transmitted infections (STIs) and to spermatozoa. In order
to help ensure that condoms are effective for contraceptive purposes and in assisting in the prevention of
transmission of STIs, it is essential that condoms fit the penis properly, are free from holes, have adequate
physical strength so as not to break during use, are correctly packaged to protect them during storage and are
correctly labelled to facilitate their use. All these issues are addressed in this International Standard.
Condoms are medical devices. Therefore they should be produced under a good quality management system.
Reference should be made, for example, to ISO 13485, the ISO 9000-series and ISO 14971.
Condoms are non-sterile medical devices but manufacturers should take appropriate precautions to minimise
microbiological contamination of the product during manufacture and packaging.
This edition of ISO 4074 requires manufacturers to conduct stability tests to estimate the shelf life of any new
or modified condom before the product is placed on the market and to initiate real time stability studies. These
requirements are described in Clause 10. The real time stability test can be considered as part of the
manufacturers’ requirement to conduct post-marketing surveillance on their products. These requirements are
intended to ensure that manufactures have adequate data to support shelf life claims before products are
placed on the market and that this data is available for review by regulatory authorities, third party test
laboratories and purchasers. They are also intended to limit the need for third parties to conduct long-term
stability studies.
A guideline ISO 16038 for the application of this International Standard has been published by ISO/TC 157.
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oSIST prEN ISO 4074:2009
DRAFT INTERNATIONAL STANDARD ISO/DIS 4074
Natural latex rubber condoms — Requirements and test
methods
1 Scope
This International Standard specifies the minimum requirements and the test methods to be used for male
condoms made from natural rubber latex which are supplied to consumers for contraceptive purposes and 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 10993-1, Biological evaluation of medical devices — Part 1: Evaluation and testing
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 delayed-type
hypersensitivity
ISO 2859-1, Sampling procedures for inspection by attributes — Part 1: Sampling schemes indexed by
acceptance quality limit (AQL) for lot-by-lot inspection
ISO 15223, Medical devices — Symbols to be used with medical device labels, labelling and information to be
supplied
EN 980, Graphical symbols for use in the labelling of medical devices
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
acceptable quality limit
AQL
quality level that is the worst tolerable process average when a continuing series of lots is submitted for
acceptance sampling (according to ISO 2859-1)
3.2
male condom
medical device used by consumers, which is intended to be retained on the penis during sexual activity, for
purposes of contraception and prevention of sexually transmitted infections
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ISO/DIS 4074
NOTE If a consumer could reasonably consider a device to be a condom (due to its shape, packaging, etc.), it is
considered a condom for the purpose of this International Standard.
3.3
consumer package
package, intended for distribution to a consumer, containing one or more individual containers of condoms
3.4
expiry date
date at the end of the shelf life
3.5
identification number
number, or combination of numerals, symbols or letters used by a manufacturer on consumer packages to
identify uniquely the lot numbers of individual condoms contained in that package, and from which it is
possible to trace those lots through all stages of manufacturing, packaging and distribution
NOTE When the consumer package contains only one kind of condoms then the identification number may be the
same as the lot number. But if the consumer package contains several different types of condoms, for instance condoms
of different shapes or colours, then the identification number will be different from the lot numbers.
3.6
individual container
primary package containing a single condom
3.7
inspection level
relationship between lot size and sample size
NOTE For description see ISO 2859-1:1999, 10.1.
3.8
lot
collection of condoms 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
3.9
lot number
number, or combination of numerals, symbols or letters used by the manufacturer to identify a lot of
individually packaged condoms, and from which it is possible to trace that lot through all stages of
manufacture up to packaging
3.10
lot test
test to assess the conformity of a lot
NOTE A lot test may be limited to include only those parameters which may change from lot to lot.
3.11
non-visible hole
hole in a condom that is not visible under normal or corrected vision but is detected by the water leak test or
the electrical test described in this International Standard
3.12
sampling plan
specific plan which 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)
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ISO/DIS 4074
3.13
shelf life
period from date of manufacture, during which condoms are required to conform to the requirements of
Clauses 9, 11 and Clause 13
3.14
visible hole
hole in the condom that is visible under normal or corrected vision before the condom is filled with water or
electrolyte during the freedom from holes test
3.15
date of manufacture
the date of dipping or the date the condoms are packed in their individual containers provided that, in the latter
case, a maximum period of bulk storage is specified and shelf life studies have been conducted on condoms
that have been subjected to the maximum bulk storage period
3.16
visible defects (other than holes and tears)
broken, missing or severely distorted rim and permanent creases with adhesion of the film
4 Quality verification
Condoms are mass produced articles manufactured in very large quantities. Inevitably there will be some
variation between individual condoms, and a small proportion of condoms in each production run might not
meet the requirements in this International Standard. Further, 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.
Basic sampling plans are given in ISO 2859-1. Reference should be made to ISO/TR 8550 for guidance on
the use of acceptance sampling system, scheme or plan for the inspection of discrete items in lots. For testing
purposes, sampling shall be conducted by lot number, not by identification number.
When on-going verification is required of the quality of condoms, it is suggested that, instead of concentrating
solely on evaluation of the final product, the party concerned also directs his attention to the manufacturer's
[10]
quality system. In this connection it should be noted that the ISO 9000 series and, in particular, ISO 13485
cover the provision of an integrated quality system.
Sampling plans shall be selected to provide an acceptable level of consumer protection. Suitable sampling
plans are given in Annexes A and B.
a) 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 their 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 recommended
when five or more lots are being tested.
b) Annex B describes sampling plans, based on ISO 2859-1, that are recommended for the assessment of
isolated lots. The sampling plans in Annex B provide approximately the same level of consumer
protection as those given in Annex A when used with the switching rules. It is recommended that these
sampling plans are 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.
c) Handling and storage conditions are to be documented before drawing the samples.
It is necessary to know the lot size in order to derive from ISO 2859-1 the number of condoms to be tested.
The lot size will vary between manufacturers and is regarded as part of the process and quality controls used
by the manufacturer.
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ISO/DIS 4074
5 Biocompatibility
For any new product or following a significant change to the formulation or manufacturing process
biocompatibility assessments shall be conducted in accordance with ISO 10993-1. Testing for cytotoxicity
according to ISO 10993-5, irritation according to ISO 10993-10 and sensitization (delayed contact
hypersensitivity) according to ISO 10993-10 shall be conducted. The condom together with any lubricant,
additive, dressing material, or powder applied to it shall be tested. Regulatory bodies may also specify
specific local requirements. Accredited laboratories shall be used for the testing. Regulatory bodies may
require the results to be interpreted by a qualified toxicologist. The biological assessment report shall justify
that the product is safe under normal conditions of use.
6 Lot size
The maximum individual lot size for production is 500 000.
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.
7 Product claims
Condoms meeting the requirements of this International Standard can be used for contraceptive purposes and
help protect against sexually transmitted infections. Manufacturers shall justify any additional claims made for
their products. If a manufacturer makes a claim relating to improved efficacy or safety then the claim shall be
substantiated by clinical investigation.
8 Design
8.1 Integral bead
The open end of the condom shall terminate in an integral bead and shall conform to Clause 12.
8.2 Lubrication
If verification is required of the quantity of lubricant in a package, the method given in Annex C shall be used.
The criteria of compliance shall be as agreed between the parties concerned.
The method in Annex C also recovers part of the dressing powder on the condom. An allowance should be
made for this when manufacturers or purchasers specify lubricant levels.
8.3 Dimensions
8.3.1 Length
When tested by the method given in Annex D, taking 13 condoms from each lot, no individual measurement
shall be below 160 mm.
8.3.2 Width
When tested by the method given in Annex E measuring at the narrowest part of the condom in the range of
20 mm to 50 mm from the open end, taking 13 condoms from each lot, no measurement of the width shall
deviate from the nominal width stated by the manufacturer by more than ± 2 mm.
Where the design of the condom is such that this measurement cannot be made reliably or the narrowest
point within the first 50 mm from the open end of the condom is at the bead, the method of measurement shall
be provided by the manufacturer.
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ISO/DIS 4074
8.3.3 Thickness
If verification is required of the thickness of a condom, the thickness, determined in accordance with one of
the methods given in Annex F shall be equal to the claimed thickness, subject to a tolerance of ± 0.01 mm.
9 Burst volume and pressure
When determined in accordance with Annex G, the bursting pressure shall not be less than 1,0 kPa and the
bursting volume shall be not less than:
3
⎯ 16,0 dm for condoms with a mid-body width less than 50,0 mm; or
3
⎯ 18,0 dm for condoms with a mid-body width greater than or equal to 50,0 mm and less than 56,0 mm; or
3
⎯ 22,0 dm for condoms with a mid-body width greater than or equal to 56,0 mm.
For the purpose of this test, take the mid-body width to be the mean flat width of 13 condoms measured in
accordance with Annex E at a point (75 ± 5) mm from the closed end.
The compliance level for each lot shall be an AQL of 1,5 for condoms that fail the requirement for volume, or
pressure or both, or any condom that exhibits obvious leakage.
10 Stability and shelf life
10.1 General
Manufacturers shall verify that the condoms comply with the requirements of Clauses 9, 11 and 13 of this
International Standard 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 compliance with this International Standard may be claimed for a new or modified condom design, the
manufacturer shall provide evidence that the following requirements have been met:
⎯ the condom shall be tested for the minimum stability requirements as described in 10.2;
⎯ a real-time study as described in 10.3 to determine shelf life shall have commenced;
⎯ pending completion of the real-time study manufacturers shall substantiate shelf-life claims as described
in 10.4.
NOTE 1 A modified condom design is one in which there have been significant changes to the formulation,
manufacturing process or individual sealed containers.
NOTE 2 Compliance with the requirements of 10.2 does not imply that the shelf life of the pro
...
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