11.200 - Birth control. Mechanical contraceptives
ICS 11.200 Details
Birth control. Mechanical contraceptives
Geburtenkontrolle. Mechanische Verhutungsmittel
Contrôle des naissances. Contraceptifs mécaniques
Načrtovanje družine. Mehanski kontracepcijski pripomočki
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This document provides guidance on assessing the effect or compatibility of an additional or personal lubricant with synthetic male condoms (excluding synthetic polyisoprene 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 intended to be used for evaluating the compatibility of chosen additional lubricants or topical medicines with chosen synthetic condoms. Each lubricant type is evaluated specifically against each condom material for which compatibility is claimed. 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 female condoms, although similar principles can apply.
- Technical specification16 pagesEnglish languagesale 15% off
This document 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 or other medicinal products.
NOTE Some aspects of this document can be applicable to medicated intrauterine devices and IUDs not containing copper.
- Standard25 pagesEnglish languagesale 10% offe-Library read for1 day
This document 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 or other medicinal products.
NOTE Some aspects of this document can be applicable to medicated intrauterine devices and IUDs not containing copper.
- Standard25 pagesEnglish languagesale 10% offe-Library read for1 day
This document 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 or other medicinal products. NOTE Some aspects of this document can be applicable to medicated intrauterine devices and IUDs not containing copper.
- Standard16 pagesEnglish languagesale 15% off
- Standard17 pagesFrench languagesale 15% off
This document gives the essential principles in the application of ISO 25841. It outlines the details of elements applicable in quality management of female condoms as required by related normative standards, as referred in ISO 25841 and other relevant concepts. This document supplements the use of ISO 25841 and addresses quality management aspects to be considered during the development, manufacture, quality verification and procurement of female condoms. It encompasses the principles of quality management systems in design, manufacture, and delivery of female condoms with emphasis on their performance, safety and reliability. This document is applicable to female condoms made of natural rubber or synthetic rubber or synthetic polymers and the retention devices which form the integral components of female condoms. NOTE Female condoms made from either natural rubber latex or synthetic rubber or other synthetic polymeric materials are addressed in ISO 25841.
- Technical report13 pagesEnglish languagesale 15% off
- Standard1 pageEnglish languagesale 15% off
- Standard1 pageEnglish languagesale 15% off
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.
- Standard27 pagesEnglish languagesale 15% off
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.
- Standard15 pagesEnglish languagesale 15% off
- Standard15 pagesEnglish languagesale 15% off
This document gives guidance on the procedures for sample preparation for determining bursting volume and pressure and testing male condoms for freedom from holes.
- Technical report9 pagesEnglish languagesale 15% off
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.
- Standard23 pagesEnglish languagesale 15% off
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.
- Standard12 pagesEnglish languagesale 15% off
ISO 4074:2015 specifies requirements and test methods for male condoms made from natural rubber latex.
- Standard69 pagesEnglish languagesale 10% offe-Library read for1 day
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).
- Standard54 pagesEnglish languagesale 15% off
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.
- Standard42 pagesEnglish languagesale 15% off
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.
- Standard40 pagesEnglish languagesale 15% off
This International Standard specifies requirements and test methods for male condoms made from
natural rubber latex.
- Standard69 pagesEnglish languagesale 10% offe-Library read for1 day
ISO 4074:2015 specifies requirements and test methods for male condoms made from natural rubber latex.
- Standard56 pagesEnglish languagesale 15% off
- Standard59 pagesFrench languagesale 15% off
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.
- Standard26 pagesEnglish languagesale 15% off
ISO 29942:2011 specifies the minimum requirements and test methods for prophylactic dams used to assist in the prevention of sexually transmitted infections.
- Standard29 pagesEnglish languagesale 15% off
- Standard1 pageEnglish languagesale 15% off
- Standard1 pageFrench languagesale 15% off
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.
- Standard44 pagesEnglish languagesale 15% off
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.
- Standard10 pagesEnglish languagesale 15% off
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.
- Standard5 pagesEnglish languagesale 15% off
- Standard5 pagesFrench languagesale 15% off
2015-02-25 - CEN/BT C014/2015 - Appeal resolved - WI stopped and to be replaced by // vote on ISO 4074 minor revision (ISO ID 67615).
2014-06-17- Appeal received from AFNOR
2013-09-25 EMA: Draft for // vote received in ISO/CS (see notification of 2013-09-24).
2012-05-04 EMA: Draft for // ENQ received in ISO/CS (see notification of 2012-05-02 in dataservice).
2012-01-04 EMA: Consultant Virefleau replaced by W. Higgins according to e-mail sent to dataservice on 2011-12-01.
- Draft69 pagesEnglish languagesale 10% offe-Library read for1 day
2012-05-04 EMA: Draft for // ENQ received in ISO/CS (see notification of 2012-05-02 in dataservice).
2012-01-04 EMA: Consultant Virefleau replaced by W. Higgins according to e-mail sent to dataservice on 2011-12-01.
- Draft69 pagesEnglish languagesale 10% offe-Library read for1 day
2011-03-18 EMA: WI deleted as equivalent ISO Project cancelled in January 2011.
- Draft53 pagesEnglish languagesale 10% offe-Library read for1 day
2011-03-18 EMA: WI deleted as equivalent ISO Project cancelled in January 2011.
- Draft53 pagesEnglish languagesale 10% offe-Library read for1 day
This International Standard 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.
NOTE Some aspects of this International Standard can be applicable to medicated intrauterine devices and
IUDs not containing copper.
- Standard20 pagesEnglish languagesale 10% offe-Library read for1 day
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.
- Standard20 pagesEnglish languagesale 10% offe-Library read for1 day
ISO - Taking over of a second ISO Technical Corrigendum
- Corrigendum3 pagesEnglish languagesale 10% offe-Library read for1 day
ISO - Taking over of an Technical Corrigendum
- Corrigendum7 pagesEnglish languagesale 10% offe-Library read for1 day
This International Standard specifies the minimum requirements and the test methods to be used for condoms made
from natural rubber latex which are supplied to consumers for contraceptive purposes and to assist in the prevention
of sexually transmitted infections.
- Standard49 pagesEnglish languagesale 10% offe-Library read for1 day
ISO - Taking over of a second ISO Technical Corrigendum
- Corrigendum3 pagesEnglish languagesale 10% offe-Library read for1 day
To align EN and ISO standards for natural rubber latex male condoms
- Standard49 pagesEnglish languagesale 10% offe-Library read for1 day
This International Standard 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.
- Standard21 pagesEnglish languagesale 10% offe-Library read for1 day
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.
- Standard21 pagesEnglish languagesale 10% offe-Library read for1 day
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.
- Standard11 pagesEnglish languagesale 15% off
- Standard11 pagesFrench languagesale 15% off
ISO 4074:2014 specifies requirements and test methods for male condoms made from natural rubber latex.
- Standard57 pagesEnglish languagesale 15% off
- Standard58 pagesFrench languagesale 15% off
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.
- Standard42 pagesEnglish languagesale 15% off
- Standard1 pageEnglish languagesale 15% off
This European Standard applies to single-use copper-containing contraceptive intrauterine devices and their insertion instruments. Contraceptive intrauterine devices consisting only of a plastics body and contraceptive intrauterine devices whose primary purpose is to release progestogens are not included in the scope of this standard.
- Standard22 pagesEnglish languagesale 10% offe-Library read for1 day
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.
- Standard40 pagesEnglish languagesale 15% off
This European Standard applies to single-use copper-containing contraceptive intrauterine devices and their insertion instruments. Contraceptive intrauterine devices consisting only of a plastics body and contraceptive intrauterine devices whose primary purpose is to release progestogens are not included in the scope of this standard.
- Standard22 pagesEnglish languagesale 10% offe-Library read for1 day
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.
- Standard11 pagesEnglish languagesale 15% off
- Standard11 pagesFrench languagesale 15% off
This European Standard applies to single-use copper-containing contraceptive intrauterine devices and their insertion instruments. Contraceptive intrauterine devices consisting only of a plastics body and contraceptive intrauterine devices whose primary purpose is to release progestogens are not included in the scope of this standard.
- Standard15 pagesEnglish languagesale 10% offe-Library read for1 day
This European Standard applies to single-use copper-containing contraceptive intrauterine devices and their insertion instruments. Contraceptive intrauterine devices consisting only of a plastics body and contraceptive intrauterine devices whose primary purpose is to release progestogens are not included in the scope of this standard.
- Standard15 pagesEnglish languagesale 10% offe-Library read for1 day
- Draft4 pagesEnglish languagesale 15% off
- Draft5 pagesFrench languagesale 15% off
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.
- Standard11 pagesEnglish languagesale 15% off
- Standard12 pagesFrench languagesale 15% off
- Standard12 pagesRussian languagesale 15% off
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.
- Standard26 pagesEnglish languagesale 15% off
ISO - Taking over of an Technical Corrigendum
- Corrigendum7 pagesEnglish languagesale 10% offe-Library read for1 day