GB/T 42168.2-2026
UpcomingCondoms—Guidance on clinical studies—Part 2:Female condoms, clinical function studies based on self-reports
避孕套 临床研究指南 第2部分：女用避孕套基于自我报告的临床功能研究
Application Summary AI generated
This standard provides guidelines for conducting clinical function studies of female condoms using self-reported data from users. It is applied in the medical device and healthcare industry, specifically for evaluating the performance, safety, and user acceptability of female condoms during clinical trials. The standard ensures consistent methodology for collecting and analyzing subjective user feedback on condom functionality.
Related Standards
GB/T 7544-2009
Natural latex rubber condoms - Requirements and test methods
GB/T 30917-2014
Determination of nitrosamines migrating from natrual rubber latex condoms
GB/T 7544-2019
Natural rubber latex male condoms—Requirements and test methods
GB/T 42168.1-2022
Condoms—Guidance on clinical studies—Part 1: Male condoms, clinical function studies based on self reports
GB/T 44875-2024
Fallopian rings—Requirements and test methods
GB/T 47200-2026
Copper-bearing intrauterine contraceptive devices—Guidance on the design, execution, analysis and interpretation of clinical studies
GB 7544.1-1999
Rubber condoms--Part 1: Requirements
GB 11236-1995
TCu intra-uterine device
Transparency note: The application summary and key sentences on this page were automatically generated by AI from the standard's original text. This content has not been human-verified and should not be used for compliance or regulatory purposes. Always refer to the official standard document from the issuing authority.