GB/T 42168.2-2026 Pending National standards

GB/T 42168.2-2026 Condoms—Guidance on clinical studies—Part 2:Female condoms,clinical function studies based on self-reports

Publish Date: 2026-03-31 Implement Date: 2027-04-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Price: $ 93.00

Out of stock

Basic Information

Standard Code: GB/T 42168.2-2026

Standard Type: National standards

Standard Status: Pending

is_force_gb: no

CCS Name: Other specialized equipment

ICS Name: Population control, contraceptive devices

Publish Date: 2026-03-31

Implement Date: 2027-04-01

Pages: 44 pages

Scope

This document provides guidance on the design, implementation, analysis, and interpretation of clinical trials of female condoms conducted in accordance with the requirements of YY/T 1567.
This document is applicable to comparing the performance of new female condoms with those already on the market during sexual intercourse (not anal intercourse) through clinical trials. The study aims to evaluate acute failure events that occur during use.
This document also provides guidance on data analysis after the completion of the trial, as well as the interpretation of the results by manufacturers and regulatory authorities.
This document does not cover certain issues related to clinical trials, including subject compensation, confidentiality of subjects and their records, and the operation of local ethics committees. Such issues and more detailed guidelines for clinical trial design can be found in YY/T 0297.