11.200 人口控制、避孕器具 标准查询与下载
共找到 243 条与 人口控制、避孕器具 相关的标准，共 17 页
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.
Copper-bearing contraceptive intrauterine devices - Requirements and tests (ISO 7439:2023)
- ICS
- 11.200
- CCS
- 发布
- 2023-04-19
- 实施
- 2023-07-31
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.
Copper-bearing contraceptive intrauterine devices — Requirements and tests
- ICS
- 11.200
- CCS
- 发布
- 2023-04-04
- 实施
- 2023-04
1 Scope 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.
Female condoms. Use of ISO 25841 and the quality management of female condoms
- ICS
- 11.200
- CCS
- 发布
- 2023-03-31
- 实施
- 2023-03-31
本文件规定了由聚氨酯胶乳制造，提供给消费者用于避孕和有助于防止性传播疾病的男用避孕套的最低技术要求和试验方法。本文件适用于100%的聚氨酯男用避孕套以及聚氨酯胶乳为主体材料的其他复合型男用避孕套。
Technical requirements and test methods for male condoms polyurethane condoms
- ICS
- 11.200
- CCS
- C36
- 发布
- 2023-01-13
- 实施
- 2024-01-15
Female condoms — Use of ISO 25841 and the quality management of female condoms
- ICS
- 11.200
- CCS
- 发布
- 2023-01-10
- 实施
- 2023-01
Additional lubricants for male natural rubber latex condoms — Effect on condom strengt
- ICS
- 11.200
- CCS
- 发布
- 2022-12-28
- 实施
This document gives guidance on the procedures for sample preparation for determining bursting volume and pressure and testing male condoms for freedom from holes.
Guidance on sample handling for determination of bursting volume and pressure, and testing for freedom from holes for male condom
- ICS
- 11.200
- CCS
- 发布
- 2022-05-12
- 实施
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.
Copper-bearing intrauterine contraceptive devices — Guidance on the design, execution, analysis and interpretation of clinical studies
- ICS
- 11.200
- CCS
- 发布
- 2022-05-12
- 实施
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.
Male condoms — Guidance on the use of ISO 4074 and ISO 23409 in the quality management of condoms
- ICS
- 11.200
- CCS
- 发布
- 2022-05-12
- 实施
Technical requirements and test methods for male condoms made of synthetic materials
- ICS
- 11.200
- CCS
- C36
- 发布
- 2021-09-06
- 实施
- 2022-09-01
Guidelines for the use of GB/T 7544 and YY/T 1777 in condom quality management for male condoms
- ICS
- 11.200
- CCS
- C36
- 发布
- 2021-09-06
- 实施
- 2022-09-01
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).
Female condoms — Requirements and test methods
- ICS
- 11.200
- CCS
- 发布
- 2021-07-01
- 实施
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.
Condoms — Guidance on clinical studies — Part 2: Female condoms, clinical function studies based on self-reports
- ICS
- 11.200
- CCS
- 发布
- 2021-07-01
- 实施
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
- ICS
- 11.200
- CCS
- 发布
- 2021-07-01
- 实施
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.
Fallopian rings — Requirements and test methods
- ICS
- 11.200
- CCS
- 发布
- 2021-07-01
- 实施
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.
Condoms — Guidance on clinical studies — Part 1: Male condoms, clinical function studies based on self-reports
- ICS
- 11.200
- CCS
- 发布
- 2021-07-01
- 实施
Natural rubber latex male condoms —Requirements and test methods
- ICS
- 11.200
- CCS
- 发布
- 2021-06-28
- 实施
Natural rubber latex male condoms —Requirements and test methods
- ICS
- 11.200
- CCS
- 发布
- 2021-06-28
- 实施
本文件规定了人体润滑剂的术语和定义、分类、要求、试验方法、检验规则、标志、包装、运输与储存。 本文件适用于主要用于性生活的人体润滑剂。
Personal Lubricant - Requirements and test methods
- ICS
- 11.200
- CCS
- O8290
- 发布
- 2020-12-11
- 实施
- 2021-01-31
本文件给出了生殖健康用品生产企业的厂区环境与布局、生产区卫生要求、设备要求、物料和仓储要求、卫生质量管理、人员要求等。 本文件适用于生殖健康用品生产（含分装）企业的生产管理。
Production management standard of reproductive health products enterprises
- ICS
- 11.200
- CCS
- O8290
- 发布
- 2020-12-11
- 实施
- 2021-01-31
