National foreword

This British Standard is the UK implementation of EN ISO 4074:2015. It supersedes BS EN ISO 4074:2002 which will be withdrawn on 11 November 2017.

The UK participation in its preparation was entrusted to Technical Committee CH/157, Mechanical contraceptives.

A list of organizations represented on this committee can be obtained on request to its secretary.

This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application.

Compliance with a British Standard cannot confer immunity from legal obligations.

This British Standard was published under the authority of the Standards Policy and Strategy Committee on 30 November 2015.

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 meaning of ISO specific terms and expressions related to conformity assessment, as well as information about ISO's adherence to the WTO principles in the Technical Barriers to Trade (TBT) see the following URL: Foreword - Supplementary information

The committee responsible for this document is ISO/TC 157, Non-systemic contraceptives and STI barrier prophylactics.

This third edition cancels and replaces the second edition (ISO 4074:2014), which has been technically revised. The modifications are as follows:

The maximum lot size has been limited to 500 000.
Specific requirements for biocompatibility assessments, as defined in ISO 10993‑1, have been added.
It is recommended that manufacturers establish procedures for the periodic monitoring of microbial contamination (bioburden) as part of their quality management system including requirements for the absence of specific pathogens and limits for total viable counts on finished condoms; methods of determining bioburden levels on condoms are given in Annex G.
Specific requirements for extra strength condoms have been deleted but there is now a general requirement for manufacturers to justify any additional claims made for their products; claims relating to improved efficacy or safety have to be substantiated by clinical investigation.
A minimum airburst volume of 28,0 dm³ has been introduced for condoms with mid-body widths that are greater than or equal to 65,0 mm and not more than 75,0 mm.
The radius of the inner edge of the clamping collar wherever it contacts the inflated condom has to be a minimum of 2 mm (Annex H).
The volumes of electrolyte used in the electrical test for determining freedom from holes described in Annex M have been brought into line with the volumes used for the water leak test.
The volumes of water or electrolyte specified in the freedom from holes test have been increased for condoms that have mid-body widths greater than or equal to 56 mm and/or are longer that 210 mm.
When conducting the electrical test for freedom from holes, the voltage is now measured from the time that the condom is first immersed and for up to 10 s after full immersion.
The method of testing for freedom from holes specified in ASTM D3492^[⁸^] has been included by reference.
A limit has been introduced for the number of individual containers with visibly open seals, to be evaluated when the containers are inspected during the freedom from holes test described in Annex M.
Recommended requirements for minimum airburst properties and freedom from holes testing for condoms narrower than 45 mm and/or shorter than 160 mm have been introduced in informative Annex P to provide guidance to regulatory authorities, notified bodies and other interested parties when assessing condoms that fall outside of the normative size range specified in this International Standard.
Amendments have been made to the methods for determining the shelf life of condoms including a simplified procedure for determining the shelf life by accelerated stability studies based on fixed ageing periods at 50 °C.
Testing for freedom from holes, airburst properties, and package integrity are required when conducting stability studies to establish that condoms meet the minimum stability requirements specified in this International Standard and when determining condom shelf lives.
The procedure for determining the thickness of a condom by the micrometer method is described in detail.
An alternative method of removing the lubricant from the condom using an aqueous surfactant solution has been introduced into the method for determining the amount of lubricant on the condom.
Revisions have been made to labelling requirements including the additional information supplied with the condom.

Regulatory agencies, notified bodies, and purchasers should consider the need for a transition period when implementing the requirements of this International Standard to allow manufacturers to make the changes required to maintain compliance. This applies particularly to the changes in packaging and labelling specified in Clause 15.

Introduction

Condoms made from intact latex film have 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. Numerous clinical studies have confirmed that male latex condoms are effective in helping to prevent pregnancy and reduce the risk of transmission of most STIs including HIV.

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 properly, are free from holes, have adequate physical strength so as not to break during use, are correctly packaged to protect them during storage, and are correctly labelled to facilitate their use. All these issues are addressed in this International Standard.

Condoms are medical devices. To ensure high quality product, it is essential that condoms are produced under a good quality management system. See ISO 13485^[⁴^] for quality management requirements and ISO 14971^[⁵^] for risk management requirements.

Condoms are non-sterile medical devices but manufacturers are advised to take appropriate precautions to minimize microbiological contamination of the product throughout the manufacturing and packaging processes. Recommendations for manufacturers to periodically monitor microbial contamination during production are included in this International Standard. Methods that can be used to determine bioburden levels are included in Annex G.

This International Standard requires manufacturers to conduct stability tests to estimate the shelf life of any new or modified condom before the product is placed on the market and to initiate real-time stability studies. These requirements are described in Clause 11. The real-time stability test can be considered as part of the manufacturers’ requirement to conduct post-marketing surveillance on their products. These requirements are intended to ensure that manufacturers have adequate data to support shelf life claims before products are placed on the market and that these data are available for review by regulatory authorities, third party test laboratories, and purchasers. They are also intended to limit the need for third parties to conduct long-term stability studies.

Condoms might be subject to specific local requirements as required by national regulatory bodies in addition to those specified in this International Standard.

ISO 16038^[⁶^] provides guidance for the application of this International Standard. It includes additional information on the test methods and requirements specified in this International Standard.

This European Standard was approved by CEN on 16 July 2015.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving thisEuropean Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical referencesconcerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CENmember.

This European Standard exists in three official versions (English, French, German). A version in any other language made bytranslation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC ManagementCentre 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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey andUnited Kingdom.

European foreword

This document (EN ISO 4074:2015) 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 European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by May 2016, and conflicting national standards shall be withdrawn at the latest by November 2017.

Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.

This document supersedes 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).

For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this document.

The following referenced documents are indispensable for the application of this document. For undated references, the latest edition of the referenced document (including any amendments) applies. For dated references, only the edition cited applies. However, for any use of this standard ‘within the meaning of Annex ZA’, the user should always check that any referenced document has not been superseded and that its relevant contents can still be considered the generally acknowledged state-of-art.

When an IEC or ISO standard is referred to in the ISO standard text, this shall be understood as a normative reference to the corresponding EN standard, if available, and otherwise to the dated version of the ISO or IEC standard, as listed below.

NOTE The way in which these referenced documents are cited in normative requirements determines the extent (in whole or in part) to which they apply.

According to the CEN-CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.

Endorsement notice

The text of ISO 4074:2015 has been approved by CEN as EN ISO 4074:2015 without any modification.

1 Scope

This International Standard specifies requirements and test methods for male condoms made from natural rubber latex.

2 Normative references

3 Terms and definitions

4 Quality verification

5 Lot size

6 Biocompatibility

7 Microbial contamination

8 Product claims

9 Design

9.1 Integral bead

9.2 Lubrication

9.3 Dimensions

10 Bursting volume and pressure

11 Stability and shelf life

11.1 General

11.2 Minimum stability requirements

11.3 Procedure for determining shelf life by real-time stability studies

11.4 Estimating shelf life based upon accelerated stability studies

12 Freedom from holes

13 Visible defects

14 Package integrity of individual container

15 Packaging and labelling

15.1 Packaging

15.2 Labelling

15.3 Inspection

16 Test report

Bibliography

BS EN ISO 4074:2015

Natural rubber latex male condoms. Requirements and test methods

Current, Under Review

Published:

30 Nov 2015