prEN ISO 4074
(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.
oSIST prEN ISO 4074:2009
oSIST prEN ISO 4074:2009
EUROPEAN STANDARD
DRAFT
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.
oSIST prEN ISO 4074:2009
Contents Page
Foreword .3
oSIST prEN ISO 4074:2009
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.
oSIST prEN ISO 4074:2009
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
oSIST prEN ISO 4074:2009
ISO/DIS 4074
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ii ISO 2009 – All rights reserved
oSIST prEN ISO 4074:2009
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
oSIST prEN ISO 4074:2009
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.
iv © ISO 2009 – All rights reserved
oSIST prEN ISO 4074:2009
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
...
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