ISO/TC 157 - Non-systemic contraceptives and STI barrier prophylactics

This document specifies the minimum requirements and test methods for fallopian rings used for tubal occlusion in women for permanent contraception. This document does not address the applicator or other accessories used to place the fallopian rings.

This document specifies a method of assessing the effect or compatibility of an additional or personal lubricant with lubricated male natural rubber latex condoms. It also applies to topical medicines and any other substances that come into contact with such condoms. It describes the measurement of changes in physical properties of the condoms after exposure to the test substance (i.e. lubricant, topical medicine, etc.) and specifies the pass/fail criteria for such changes. This document is not applicable to the assessment of the compatibility of lubricants applied to a condom at the time of manufacture. It is not directly applicable to the assessment of the compatibility of a particular condom with lubricants or other substances. It is not directly applicable to tests using female condoms, although similar principles can apply. The test methods are applicable to condoms made from natural rubber latex and from synthetic materials, but a pass/fail criterion is only stipulated for natural rubber latex.

This document gives guidance on the procedures for sample preparation for determining bursting volume and pressure and testing male condoms for freedom from holes.

ISO 11249:2018 provides guidance on the design and conduct of clinical studies to determine the performance characteristics of new intrauterine devices. It also provides advice on the analysis of data when the study is completed, as well as interpretation of these results by manufacturers, researchers and regulatory bodies. ISO 11249:2018 is intended to ensure the scientific conduct of the clinical investigation and the credibility of the clinical investigation results, and to assist sponsors, monitors, investigators, ethics committees, regulatory authorities and other bodies involved in the conformity assessment of medical devices. Certain clinical trial concerns are not addressed in this document, including subject compensation, confidentiality of subjects and their records, use of local ethics committees, etc. These and many other clinical trial design issues are covered in great detail in ISO 14155.

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.

ISO 25841:2017 specifies the minimum requirements and test methods for female condoms that are supplied to consumers for contraceptive purposes and for assisting in the prevention of sexually transmitted infections (STIs).

ISO 29943-2:2017 is intended to help in the design, execution, analysis, and interpretation of clinical function studies conducted in accordance with the requirements of ISO 25841 for female condoms. These clinical studies compare the performance of a new female condom to an established female condom during vaginal intercourse (not anal intercourse). In particular, these studies are designed to assess acute failure events during use. ISO 29943-2:2017 also provides direction on the analysis of data when the study is completed, as well as interpretation of these results by manufacturers and regulatory bodies. Certain clinical trial elements are not addressed in this document, including compensation, confidentiality of individuals and their records, use of local ethics committees, etc. These and many other clinical trial design issues are covered in greater detail in ISO 14155.

ISO 29943-1:2017 is intended to help in the design, execution, analysis and interpretation of clinical function studies conducted in accordance with the requirements of ISO 23409 for male synthetic condoms. These clinical studies compare the performance of a new male condom to an established male condom during vaginal intercourse (not anal intercourse). In particular, these studies are designed to assess acute failure events during use (i.e. clinical slippage and clinical breakage). ISO 29943-1:2017 also provides direction on the analysis of data when the study is completed, as well as interpretation of these results by manufacturers and regulatory bodies. Certain clinical trial elements are not addressed in this document, including compensation, confidentiality of individuals and their records, use of local ethics committees, etc. These and many other clinical trial design issues are covered in greater detail in ISO 14155.

ISO 4074:2015 specifies requirements and test methods for male condoms made from natural rubber latex.

ISO 7439:2015 specifies requirements and tests for single-use, copper-bearing contraceptive intrauterine devices (IUDs) and their insertion instruments. It is not applicable to IUDs consisting only of a plastics body or whose primary purpose is to release progestogens.

ISO 8009:2014 specifies the minimum requirements and test methods to be used for reusable diaphragms made from natural rubber and silicone rubber. These diaphragms are intended for contraceptive use.

ISO 29942:2011 specifies the minimum requirements and test methods for prophylactic dams used to assist in the prevention of sexually transmitted infections.

ISO 23409:2011 specifies the minimum requirements and the test methods applicable to male condoms produced from synthetic materials or blends of synthetic materials and natural rubber latex which are used for contraceptive purposes and to aid in the prevention of sexually transmitted infections.

ISO 29941:2010 specifies a test method to determine the release of N-nitrosamines from condoms made from natural rubber latex. The method can also be used for other products such as probe covers, prophylactic dams, female condoms and condoms made from synthetic materials, although there was no experience of testing such products at the time of publication.

This International Standard is intended as a guideline for clinical researchers working with condoms. It suggests a series of laboratory tests to be conducted on the products to be used in any clinical investigation, so that it will be easier to relate the clinical results to the design and quality of the condoms used. This International Standard is not applicable to the design of clinical investigations.

ISO 4074:2014 specifies requirements and test methods for male condoms made from natural rubber latex.

ISO 25841:2014 specifies the minimum requirements and test methods for female condoms, which are supplied to consumers for contraceptive purposes, assisting in the prevention of sexually transmitted infections.

ISO 25841:2011 specifies the minimum requirements and test methods for female condoms, which are supplied to consumers for contraceptive purposes assisting in the prevention of sexually transmitted infections.

ISO 7439:2010 specifies requirements and tests for single-use, copper-bearing contraceptive intrauterine devices (IUDs) and their insertion instruments. (Some aspects can be applicable to medicated intrauterine devices and IUDs not containing copper.) It is not applicable to IUDs consisting only of a plastics body or whose primary purpose is to release progestogens.

ISO 16038:2005 provides guidance on using ISO 4074 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 design, manufacture and delivery of condoms with emphasis on performance, safety and reliability of condoms.

ISO 8009:2004 specifies the minimum requirements and test methods to be used for reusable diaphragms made from natural rubber and silicone rubber. These diaphragms are intended for contraceptive use. ISO 8009:2004 is not applicable to other vaginal contraceptive barriers, such as those known as cervical caps, vaginal sponges and vaginal sheaths.

ISO 7439:2002 is applicable to single-use copper-bearing intra-uterine contraceptive devices and their insertion instruments. ISO 7439:2002 is not applicable to intra-uterine contraceptive devices consisting only of a plastics body and intra-uterine contraceptive devices whose primary purpose is to release progestogens. Some aspects of ISO 7439:2002 are applicable to medicated intra-uterine devices and intra-uterine devices that do not contain copper.

Describes a method for determining the tensile properties of the dome of reusable rubber contraceptive diaphragms. Replaces the first edition.

Specifies two alternative methods for determining visible defects in reusable rubber contraceptive diaphragms, the inspection over a lamp and inspection by inflation. The methods are of equal validity. Replaces the first edition.

Describes requirements for condoms made from natural rubber latex, provided for contraceptive purposes an to assist in the prevention of sexually transmitted diseases.

Describes a method for the determination of the resistance of packaged condoms to deterioration during storage. Replaces the first edition.

Specifies the method of determining the tensile properties of rubber condoms. Replaces the first edition.

Describes the method of determining the bursting volume and pressure of rubber condoms. Replaces the second edition.

Describes a method of testing a rubber condom for holes by observing any leakage from the condom after it has been filled with water. Replaces the second edition.

Cancels and replaces the first edition (1980). Specifies a method of determining the length of rubber condoms by free hanging of the unrolled condom over a graduated mandrel and measurement of its length, the reservoir excluded.

Cancels and replaces the first edition (1980). Specifies a method of determining the width of rubber condoms by free hanging of the unrolled condom over the edge of a ruler and measurement of its width.

Gives requirements. The articles are to be packed in an individual sealed container in hygienically satisfactory conditions.Several individual containers may be packed together in a consumer package. They have to carry some important information.

Lays down recommendations on storage conditions to be considered by manufacturers and distributors.

Gives requirements. Each article shall be individually packaged in a container designed to protect it from contamination and mechanical damage during normal handlung, transport and storage. Articles and containers shall be legibly marked with some important information.

Gives a method for measurement by means of a specified dial gauge which is graduated in divisions of not more than 0,01 mm.

Specifies a measuring method. This method is not applicable to diaphragms with springs designed to form an arc when compressed. Compression of the rim of the article across its diameter using a suitable apparatus. Determination of the deviation of the rim from the horizontal plane.

Includes a measuring method consisting in the measurement of the external diameter by a measuring device the scale of which is graduated in millimeters.

Specifies a measuring method. This method is not applicable to diaphragms with springs designed to form an arc when compressed. Compression of the article across its diameter with a mass of 280 g using a suitable apparatus. Determination of the change in diameter after 15 s.

Includes methods for determining the resistance to deterioration. Conditioning of the test pieces at an elevated temperature for a specified time. Examination of the test pieces followed by measuring of the tensile strength and elongation at break in accordance with ISO 8009-5.