ISO 16038:2017
(Main)Male condoms — Guidance on the use of ISO 4074 and ISO 23409 in the quality management of condoms
Male condoms — Guidance on the use of ISO 4074 and ISO 23409 in the quality management of condoms
ISO 16038:2017 provides guidance on using ISO 4074 and ISO 23409 and addresses quality issues to be considered during the development, manufacture, quality verification and procurement of condoms. It encompasses the aspects of quality management systems in the design, manufacture and delivery of condoms with an emphasis on performance, safety and reliability. Male condoms are either made from essentially natural rubber latex, in which case the requirements of ISO 4074 are applicable, or from synthetic materials and/or blends of synthetic materials and natural rubber latex, in which case the requirements of ISO 23409 are applicable. This document outlines the aspects applicable to both types of condoms with specific clarifications where appropriate.
Préservatifs masculins — Lignes directrices sur l’utilisation de la norme ISO 4074 et ISO 23409 sur le management de la qualité des préservatifs en latex de caoutchouc naturel et en matériau synthétiques
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INTERNATIONAL ISO
STANDARD 16038
Second edition
2017-11
Male condoms — Guidance on the
use of ISO 4074 and ISO 23409 in the
quality management of condoms
Préservatifs masculins — Lignes directrices sur l’utilisation de la
norme ISO 4074 et ISO 23409 sur le management de la qualité
des préservatifs en latex de caoutchouc naturel et en matériau
synthétiques
Reference number
©
ISO 2017
© ISO 2017, Published in Switzerland
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ii © ISO 2017 – All rights reserved
Contents Page
Foreword .iv
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Quality of design . 1
4.1 General . 1
4.2 Clinical investigation . 3
4.3 Risk management . 3
4.3.1 Risk analysis and risk management . 3
4.3.2 Latex allergy . 3
4.3.3 Microbial contamination (bioburden) . 4
4.3.4 Nitrosamines . 4
5 Quality of manufacture . 4
5.1 Quality management . 4
5.2 Lot testing (finished product testing) . 4
5.3 Rounding-off values . 5
6 Quality in procurement . 5
7 Quality in testing . 6
8 Important parameters to consider when using ISO 4074 and ISO 23409 .6
8.1 Application of ISO 4074 and ISO 23409 . 6
8.2 Dimensions . 6
8.3 Visibly open seals . 7
8.4 Justification of additional claims . 7
8.5 Compatibility of materials . 7
8.6 Freedom from holes. 8
8.7 Shelf life and resistance to degradation . 8
8.8 Packaging and labelling . 9
8.9 Type testing .10
8.10 Lubricants .10
9 Sampling .10
Bibliography .11
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.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).
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. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www.iso.org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation on the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO’s adherence to the
World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see the following
URL: www.iso.org/iso/foreword.html.
This document 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 16038:2005), which has been technically
revised, considering the revisions to ISO 4074 and the publication of ISO 23409. The modifications are
as follows.
a) The title and Scope have been expanded to include ISO 23409 and the relevant aspects of synthetic
male condoms have been added in this edition. The major points incorporated are with respect to
design, determination of limits for burst properties, stability studies and clinical trials.
b) The revision to ISO 4074 and points arising out of the publication of ISO 4074:2015 have been
incorporated in the guidance document.
c) An explanation regarding the application of switching rules in sampling in accordance with
ISO 2859-1 has been incorporated.
d) The section on design has been expanded to explain significant changes to condoms, which warrant
validation.
e) The principle of estimating shelf life of natural rubber latex condoms has been revised to reflect
the principles of shelf determination as given in ISO 4074:2015.
f) The section on testing has been revised to include the modifications to test methods for determining
freedom for holes.
g) The section on dimensions has been revised to include the aspects of tolerances for thinner
condoms.
h) The aspects of condoms of smaller and larger sizes than those specified in ISO 4074 have been
incorporated.
iv © ISO 2017 – All rights reserved
i) The impact of new test for visibly open seals as given in ISO 4074 and potential rework has been
addressed.
j) The control of maximum storage period of naked condoms before packing them in individual sealed
containers has been incorporated in accordance with ISO 4074.
Introduction
Condoms are medical devices used for contraception and for prevention of sexually transmitted
infections.
ISO 4074 is a quality standard for natural rubber latex condoms and ISO 23409 for condoms made from
synthetic materials. They are reference documents for standardized end product quality test protocols
and a baseline specification for critical attributes that affect condom safety and effectiveness. They are
applied by manufacturers, procurement agencies, regulatory bodies and testing laboratories.
The use of ISO 4074 and or ISO 23409 does not by itself ensure consistency in quality; consistent high
quality at the lowest possible cost is attained only through a regime termed quality management,
through which, quality is built into the product and ensured at every point in the design, planning,
production and procurement processes. This document should lead to continuous improvement in
manufacturing, procurement and testing processes. The special requirements of buyers and consumers
should also be given due consideration when applying ISO 4074 or ISO 23409, as ISO 4074 and ISO 23409
are general by design, and will not cover all circumstances completely.
This document provides guidance to manufacturers, buyers and third-party test laboratories on
implementing and applying ISO 4074 in the manufacture of condoms, and to purchasers on applying
ISO 4074 or ISO 23409 and verifying that the condoms delivered conform to the specification, as
appropriate.
Acceptable condoms meet or exceed the minimum requirements specified in ISO 4074 or ISO 23409, as
applicable.
It is not possible, nor is it required, to subject condoms to user trials on a batch-by-batch basis. For this
reason, certain evaluations are carried out only in the case of a pre-market validation; for example for
new or significantly modified designs.
Design validation requirements normally include all the good manufacturing practice (GMP) validation
requirements and the validation requirements of ISO 9001 and ISO 13485; these are not currently
covered by ISO 4074 and ISO 23409, but are generally included by regulatory authorities as prerequisites
for registering new designs of medical devices. Design considerations such as stability testing, etc., are,
however, covered in ISO 4074 and evaluation of barrier properties by clinical trials and determination
of burst properties are covered in ISO 23409.
ISO 4074 and ISO 23409 are mainly concerned with finished product testing carried out to monitor or
to verify that the condoms have been manufactured with an adequate level of consistency in quality.
For this purpose, tests have been designed that can be carried out rapidly and economically. The
requirements in ISO 4074 and ISO 23409 are based on those properties which, based upon current
knowledge, are believed to be relevant to the performance of condoms in normal use.
Some important properties of condoms are nevertheless difficult to define in quantitative terms
because of a lack of controlled studies, the absence of practical and economical tests, and the need for
different specifications to suit different users. ISO 4074 and ISO 23409 are, therefore, focused on the
essential properties where limits can be clearly defined. Other properties are addressed only in general
terms and are meant to be augmen
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