11.200 人口控制、避孕器具 标准查询与下载

KS M ISO 8009-2018(2023) 机械避孕药具.可重复使用的天然和硅橡胶避孕膜.要求和试验

Mechanical contraceptives — Reusable natural and silicone rubber contraceptive diaphragms — Requirements and tests

KS M ISO 16037:2018 用于临床试验的橡胶避孕套 - 物理性能的测量

Rubber condoms for clinical trials — Measurement of physical properties

ISO 19671:2018 安全套附加润滑剂 - 对避孕套强度的影响

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.

Additional lubricants for male natural rubber latex condoms — Effect on condom strength

ISO/TR 19969:2018 男用避孕套破裂体积和压力的测定以及无孔性试验的样品处理指南

Guidance on sample handling for determination of bursting volume and pressure, and testing for freedom from holes for male condom

ASTM D6976-13(2018) 橡胶避孕药标准规范&x2014；阴道横膈膜

1.1 This specification covers requirements for contraceptive vaginal diaphragms, hereafter called diaphragms. 1.2 Vaginal barrier devices known as cervical caps, vaginal sponges and female condoms are not included in this specification. 1.3 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

Standard Specification for Rubber Contraceptives—Vaginal Diaphragms

ASTM D7661-18 测定个人润滑剂与天然橡胶乳胶避孕套相容性的标准试验方法

1.1 This test method covers procedures used to detect a shift in physical properties of natural rubber latex (NRL) condoms after immersion in a personal lubricant. “Personal lubricants” are lubricants such as liquids or gels that are applied by the consumer at the time of condom use. 1.2 This test method does not attempt to address compatibility of lubricants applied to a condom at the time of manufacture (“manufacturer lubricants”). It shall be the responsibility of the condom manufacturer to verify the longterm stability (shelf life) of any manufacturer lubricant that is packaged within the individual condom wrapper. Other regulatory requirements may apply. 1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use. 1.5 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms

DB32/T 3395-2018 鸡孵化厂菌落总数检测与评判

Detection and evaluation of total bacterial colony in chicken hatchery

BS ISO 11249:2018 含铜宫内避孕器 临床研究的设计、执行、分析和解释指南

1   Scope This document 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. It 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.

Copper-bearing intrauterine contraceptive devices. Guidance on the design, execution, analysis and interpretation of clinical studies

ISO 11249:2018 含铜宫内节育器.临床研究的设计、实施、分析和解释指南

This document 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. It 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.

Copper-bearing intrauterine contraceptive devices - Guidance on the design, execution, analysis and interpretation of clinical studies

BS ISO 16038:2017 男用避孕套 关于在安全套质量管理中使用 ISO 4074 和 ISO 23409 的指南

Male condoms. Guidance on the use of ISO 4074 and ISO 23409 in the quality management of condoms

ISO 16038:2017 橡胶避孕套.关于天然橡胶胶乳避孕套质量管理的ISO 4047的使用指南

This document 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 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.

Male condoms - Guidance on the use of ISO 4074 and ISO 23409 in the quality management of condoms

BS ISO 25841:2017 女性用安全套. 要求和试验方法

Female condoms. Requirements and test methods

ISO 25841:2017 女用避孕套 - 要求和测试方法

This document 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).

Female condoms — Requirements and test methods

BS ISO 29943-2:2017 避孕套 临床研究指南 女性避孕套，基于自我报告的临床功能研究

Condoms. Guidance on clinical studies. Female condoms, clinical function studies based on self-reports

BS ISO 29943-1:2017 避孕套 临床研究指南 男用避孕套，基于自我报告的临床功能研究

Condoms. Guidance on clinical studies. Male condoms, clinical function studies based on self-reports

ISO 29943-2:2017 避孕套. 临床研究指南. 第2部分：女性避孕套，基于自我报告的临床功能研究

This document 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. This document 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.

Condoms - Guidance on clinical studies - Part 2: Female condoms, clinical function studies based on self-reports

ISO 29943-1:2017 避孕套. 临床研究指南. 第1部分：男用安全套，基于自我报告的临床功能研究

This document 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). This document 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.

Condoms - Guidance on clinical studies - Part 1: Male condoms, clinical function studies based on self-reports

GSO ISO 7439:2016 含铜宫内节育器 要求和测试

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.

Copper-bearing contraceptive intrauterine devices -- Requirements and tests

GSO ISO 8009:2016 机械避孕药可重复使用的天然和硅橡胶避孕隔膜要求和测试

This International Standard 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. This International Standard is not applicable to other vaginal contraceptive barriers, such as those known as cervical caps, vaginal sponges, and vaginal sheaths.

Mechanical contraceptives -- Reusable natural and silicone rubber contraceptive diaphragms -- Requirements and tests

HG/T 5056-2016 GB 7544在天然橡胶胶乳避孕套质量管理中的使用指南

本标准是GB 7544的使用指南，规定了避孕套在开发、生产、质量认证以及采购时涉及的质量问题。 本标准以避孕套在设计、生产以及流通环节的质量管理体系为中心，强调避孕套的性能、安全和可靠性。

Rubber condoms.Guidance on the use of GB 7544 in the quality management of natural rubber latex condoms