GB/T 42168.1-2022 Active National standards

GB/T 42168.1-2022 Condoms—Guidance on clinical studies—Part 1:Male condoms,clinical function studies based on self reports

Publish Date: 2022-12-30 Implement Date: 2024-01-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: GB/T 42168.1-2022

Standard Type: National standards

Standard Status: Active

is_force_gb: no

CCS Name: Other specialized equipment

ICS Name: Population control, contraceptive devices

Publish Date: 2022-12-30

Implement Date: 2024-01-01

Pages: 40 pages

Scope

This document provides guidance for the design, implementation, analysis, and interpretation of clinical function studies conducted in accordance with the requirements of ISO 23409. This document is applicable to comparing the performance of new male condoms with those already on the market during vaginal intercourse (not anal intercourse). The main purpose of the study is to evaluate acute failure events during use (i.e., clinical slippage and clinical breakage). This document also provides data analysis upon completion of the study, as well as interpretation of the results by manufacturers and regulatory authorities. This document does not specify certain elements of clinical trials, including compensation, confidentiality of personal information and records, and involvement of local ethics committees. For more details on these and other issues related to clinical trial design, please refer to ISO 14155.