oSIST prEN ISO 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)

Kondomi iz naravnega kavčuka - Zahteve in preskusne metode (ISO/DIS 4074:2024)

General Information

• Status: Not Published
• Public Enquiry End Date: 29-Sep-2024
• ICS: 11.200 - Birth control. Mechanical contraceptives
• Technical Committee: VAZ - Healthcare
• Current Stage: 4020 - Public enquire (PE) (Adopted Project)
• Start Date: 01-Aug-2024
• Due Date: 19-Dec-2024
• Directive: 2017/745 - Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
• Mandate: M/575 - Medical devices in support of Regulation (EU) 2017/745 and in vitro diagnostic medical devices in support of Regulation (EU) 2017/746
• Ref Project: prEN ISO 4074 - Natural rubber latex male condoms - Requirements and test methods (ISO/DIS 4074:2024)

Relations

• Replaces: SIST EN ISO 4074:2016 - Natural rubber latex male condoms - Requirements and test methods (ISO 4074:2015)
• Effective Date: 15-Dec-2021

Standards Content (Sample)

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
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,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
ISO/CEN PARALLEL PROCESSING
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.
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
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
or ISO’s member body in the country of the requester.
NATIONAL REGULATIONS.
ISO copyright office
RECIPIENTS OF THIS DRAFT ARE INVITED
CP 401 • Ch. de Blandonnet 8
TO SUBMIT, WITH THEIR COMMENTS,
CH-1214 Vernier, Geneva
NOTIFICATION OF ANY RELEVANT PATENT
Phone: [phone]
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION.
Email: [e-mail]
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 (
...