GB/T 42168.1-2022
Condoms—Guidance on clinical studies—Part 1: Male condoms, clinical function studies based on self reports (English Version)
- Standard No.
- GB/T 42168.1-2022
- Language
- Chinese, Available in English version
- Release Date
- 2022
- Published By
- General Administration of Quality Supervision, Inspection and Quarantine of the People‘s Republic of China
- Latest
- GB/T 42168.1-2022
- Scope
- This document is provided to aid in the design, execution, analysis and interpretation of clinical functional studies according to the requirements of ISO23409. This document is applicable to compare the performance of the new male condom and the marketed male condom during vaginal intercourse (non-anal intercourse). The primary objective of the study was to assess acute failure events (i.e., clinical slippage and clinical breakage) during use. This document also provides an analysis of the data at the completion of the study, as well as an interpretation of the results by the manufacturer and regulatory agencies, etc. Certain clinical trial elements are not specified in this document, including compensation, confidentiality of personal information and records, participation of local ethics committees, etc. These and other clinical trial design issues are detailed in ISO 14155.
GB/T 42168.1-2022 history
- 2022 GB/T 42168.1-2022 Condoms—Guidance on clinical studies—Part 1: Male condoms, clinical function studies based on self reports
