FprEN ISO 4074
(Main)Natural rubber latex male condoms - Requirements and test methods (ISO/FDIS 4074:2014)
Natural rubber latex male condoms - Requirements and test methods (ISO/FDIS 4074:2014)
2015-02-25 - CEN/BT C014/2015 - Appeal resolved - WI stopped and to be replaced by // vote on ISO 4074 minor revision (ISO ID 67615).
2014-06-17- Appeal received from AFNOR
2013-09-25 EMA: Draft for // vote received in ISO/CS (see notification of 2013-09-24).
2012-05-04 EMA: Draft for // ENQ received in ISO/CS (see notification of 2012-05-02 in dataservice).
2012-01-04 EMA: Consultant Virefleau replaced by W. Higgins according to e-mail sent to dataservice on 2011-12-01.
Kondome aus Naturkautschuklatex - Anforderungen und Prüfverfahren (ISO/FDIS 4074:2014)
Diese Internationale Norm legt die anzuwendenden Anforderungen und Prüfverfahren für aus Natur-kautschuklatex hergestellte Kondome für Männer fest.
Préservatifs masculins en latex de caoutchouc naturel - Exigences et méthodes d'essai (ISO/FDIS 4074:2014)
Kondomi iz naravnega kavčuka - Zahteve in preskusne metode (ISO/FDIS 4074:2014)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
oSIST prEN ISO 4074:2012
01-julij-2012
.RQGRPLL]QDUDYQHJDNDYþXND=DKWHYHLQSUHVNXVQHPHWRGH ,62',6
Natural latex rubber condoms - Requirements and test methods (ISO/DIS 4074:2012)
Kondome aus Naturkautschuklatex - Anforderungen und Prüfverfahren (ISO/DIS
4074:2012)
Préservatifs masculins en latex de caoutchouc naturel - Exigences et méthodes d'essai
(ISO/DIS 4074:2012)
Ta slovenski standard je istoveten z: prEN ISO 4074
ICS:
11.200 1DþUWRYDQMHGUXåLQH Birth control. Mechanical
0HKDQVNLNRQWUDFHSFLMVNL contraceptives
SULSRPRþNL
oSIST prEN ISO 4074:2012 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
oSIST prEN ISO 4074:2012
oSIST prEN ISO 4074:2012
EUROPEAN STANDARD
DRAFT
prEN ISO 4074
NORME EUROPÉENNE
EUROPÄISCHE NORM
May 2012
ICS 11.200 Will supersede EN ISO 4074:2002
English Version
Natural latex rubber condoms - Requirements and test methods
(ISO/DIS 4074:2012)
Préservatifs masculins en latex de caoutchouc naturel - Kondome aus Naturkautschuklatex - Anforderungen und
Exigences et méthodes d'essai (ISO/DIS 4074:2012) Prüfverfahren (ISO/DIS 4074:2012)
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-CENELEC Management
Centre has the same status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, 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, Turkey 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
© 2012 CEN All rights of exploitation in any form and by any means reserved Ref. No. prEN ISO 4074:2012: E
worldwide for CEN national Members.
oSIST prEN ISO 4074:2012
prEN ISO 4074:2012 (E)
Contents Page
Foreword .3
oSIST prEN ISO 4074:2012
prEN ISO 4074:2012 (E)
Foreword
This document (prEN ISO 4074:2012) has been prepared by Technical Committee ISO/TC 157 "Non-systemic
contraceptives and STI barrier prophylactics" 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 EU Directive(s).
Endorsement notice
The text of ISO/DIS 4074:2012 has been approved by CEN as a prEN ISO 4074:2012 without any
modification.
oSIST prEN ISO 4074:2012
oSIST prEN ISO 4074:2012
DRAFT INTERNATIONAL STANDARD ISO/DIS 4074
ISO/TC 157 Secretariat: DSM
Voting begins on Voting terminates on
2012-05-17 2012-10-17
INTERNATIONAL ORGANIZATION FOR STANDARDIZATION МЕЖДУНАРОДНАЯ ОРГАНИЗАЦИЯ ПО СТАНДАРТИЗАЦИИ ORGANISATION INTERNATIONALE DE NORMALISATION
Natural rubber latex male condoms — Requirements and test
methods
Préservatifs masculins en latex de caoutchouc naturel — Exigences et méthodes d'essai
[Revision of first edition (ISO 4074:2002), ISO 4074:2002/Cor.1:2003 and ISO 4074:2002/Cor.2:2008]
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, 2012
oSIST prEN ISO 4074:2012
ISO/DIS 4074
Copyright notice
This ISO document is a Draft International Standard and is copyright-protected by ISO. Except as permitted
under the applicable laws of the user’s country, neither this ISO draft nor any extract from it may be
reproduced, stored in a retrieval system or transmitted in any form or by any means, electronic,
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ii © ISO 2012 – All rights reserved
oSIST prEN ISO 4074:2012
ISO/DIS 4074
Contents Page
Foreword .v
Introduction.vii
1 Scope.1
2 Normative references.1
2 Terms and definitions .1
3 Quality verification .3
4 Lot size .3
5 Biocompatibility.4
6 Microbial contamination .4
7 Product claims.4
8 Design.4
9 Bursting volume and pressure .5
10 Stability and shelf life.6
11 Freedom from holes.7
12 Visible defects .7
13 Package integrity of individual container .7
14 Packaging and labelling .8
15 Test report.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.12
Annex B (informative) Sampling plans intended for assessing compliance of isolated lots .14
Annex C (normative) Determination of total lubricant for condoms in individual containers.15
Annex D (normative) Determination of length .18
Annex E (normative) Method for the determination of width.20
Annex F (normative) Determination of thickness.21
Annex G (informative) Determination of microbial contamination .24
Annex H (normative) Determination of bursting volume and pressure .28
Annex I (normative) Oven treatment for condoms.31
Annex J (informative) Determination of force and elongation at break of test pieces of condoms.32
Annex K (normative) Determination of shelf life by real-time stability studies.34
Annex L (informative) Guidance on conducting and analysing accelerated ageing studies .36
Annex M (normative) Testing for holes .38
Annex N (normative) Testing for package integrity .48
Annex O (informative) Calibration of air inflation equipment for determination of bursting volume
and pressure .50
oSIST prEN ISO 4074:2012
ISO/DIS 4074
Annex P (informative) Recommendations for testing condoms that fall outside of the size ranges
specified in ISO 4074. 54
Bibliography. 57
Annex ZA (informative) Relationship between this International Standard and the Essential
Requirements of EU Directives 93/42/EEC. 59
iv © ISO 2012 – All rights reserved
oSIST prEN ISO 4074:2012
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, Non-systemic contraceptives and STI barrier
prophylactics.
This second edition cancels and replaces the first edition (ISO 4074:2002, ISO 4074:2002/Cor.1:2003,
ISO 4074:2002/Cor.2:2008), which has
...
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