prEN ISO 4074

SLOVENSKI STANDARD
01-september-2024
Nadomešča:
SIST EN ISO 4074:2016
Kondomi iz naravnega kavčuka - Zahteve in preskusne metode (ISO/DIS
4074:2024)
Natural rubber latex male condoms - Requirements and test methods (ISO/DIS
4074:2024)
Kondome aus Naturkautschuklatex für Männer- Anforderungen und Prüfverfahren
(ISO/DIS 4074:2024)
Préservatifs masculins en latex de caoutchouc naturel - Exigences et méthodes d'essai
(ISO/DIS 4074:2024)
Ta slovenski standard je istoveten z: prEN ISO 4074
ICS:
11.200 Načrtovanje družine. Birth control. Mechanical
Mehanski kontracepcijski contraceptives
pripomočki
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

DRAFT
International
Standard
ISO/DIS 4074
ISO/TC 157
Natural rubber latex male
Secretariat: DSM
condoms — Requirements and test
Voting begins on:
methods
2024-07-23
Préservatifs masculins en latex de caoutchouc naturel —
Voting terminates on:
Exigences et méthodes d'essai
2024-10-15
ICS: 11.200
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
IS THEREFORE SUBJECT TO CHANGE
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NATIONAL REGULATIONS.
RECIPIENTS OF THIS DRAFT ARE INVITED
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NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION.
Reference number
ISO/DIS 4074:2024(en)
DRAFT
ISO/DIS 4074:2024(en)
International
Standard
ISO/DIS 4074
ISO/TC 157
Natural rubber latex male condoms —
Secretariat: DSM
Requirements and test methods
Voting begins on:
Préservatifs masculins en latex de caoutchouc naturel —
Exigences et méthodes d'essai
Voting terminates on:
ICS: 11.200
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
IS THEREFORE SUBJECT TO CHANGE
AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
PUBLISHED AS SUCH.
This document is circulated as received from the committee secretariat.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
© ISO 2024
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
STANDARDS MAY ON OCCASION HAVE TO
ISO/CEN PARALLEL PROCESSING
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
BE CONSIDERED IN THE LIGHT OF THEIR
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NATIONAL REGULATIONS.
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TO SUBMIT, WITH THEIR COMMENTS,
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Website: www.iso.org
Published in Switzerland Reference number
ISO/DIS 4074:2024(en)
ii
ISO/DIS 4074:2024(en)
Contents Page
Foreword .v
Introduction .vii
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Quality verification . 3
5 Lot size . 4
6 Biocompatibility . 4
7 Microbial contamination . 4
8 Product claims . 5
9 Design . 5
9.1 Dimensions .5
9.1.1 Length .5
9.1.2 Nominal width .5
9.1.3 Thickness .5
9.2 Integral bead .5
9.3 Lubrication .5
10 Bursting volume and pressure . 5
11 Stability and shelf life . 6
11.1 General .6
11.2 Minimum stability requirements . .7
11.3 Procedure for determining shelf life by real-time stability studies .7
11.4 Estimating shelf life based upon accelerated stability studies .7
12 Freedom from holes. 8
13 Visible defects . 8
14 Package integrity of individual container . 8
15 Packaging and labelling . 8
15.1 Packaging .8
15.2 Labelling .9
15.2.1 General .9
15.2.2 Symbols.9
15.2.3 Individual container .9
15.2.4 Consumer package .9
15.2.5 Condoms not distributed in consumer packages .11
15.3 Inspection .11
16 Test report .12
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 .13
Annex B (informative) Sampling plans intended for assessing compliance of isolated lots .15
Annex C (normative) Determination of total lubricant for condoms in individual containers .16
Annex D (normative) Determination of length .20
Annex E (normative) Determination of width . .22
Annex F (normative) Determination of thickness .23
Annex G (informative) Determination of microbial contamination .26

iii
ISO/DIS 4074:2024(en)
Annex H (normative) Determination of bursting volume and pressure .31
Annex I (normative) Oven treatment for condoms .38
Annex J (informative) Determination of force and elongation at break of test pieces of condoms .39
Annex K (normative) Determination of shelf life by real-time stability studies .42
Annex L (informative) Guidance on conducting and analysing accelerated ageing studies .45
Annex M (normative) Testing for holes .50
Annex N (normative) Testing for package integrity .62
Annex O (normative) Calibration of air inflation equipment for determination of bursting
volume and pressure .66
Annex P (normative) Requirements for testing condoms that fall outside of the length and
width ranges specified in Clause 9 .72
Annex Q (normative) Verification Procedure for the Freedom from Holes Test . 74
Annex ZA (
...