GB/T 47200-2026 Pending National standards

GB/T 47200-2026 Copper-bearing intrauterine contraceptive devices—Guidance on the design,execution,analysis and interpretation of clinical studies

Publish Date: 2026-02-27 Implement Date: 2027-03-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

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Basic Information

Standard Code: GB/T 47200-2026

Standard Type: National standards

Standard Status: Pending

is_force_gb: no

CCS Name: Other specialized equipment

ICS Name: Population control, contraceptive devices

Publish Date: 2026-02-27

Implement Date: 2027-03-01

Pages: 24 pages

Scope

This document provides guidance on the design and implementation of clinical trials aimed at determining the performance characteristics of new copper-containing intrauterine devices, as well as data analysis after the completion of the study, and recommendations for the interpretation of the results by manufacturers, researchers, and regulatory authorities.
This document is intended to provide support to sponsors, monitors, researchers, ethics committees, regulatory authorities, and other institutions involved in the compliance assessment of medical devices.
This document does not address certain issues related to clinical trials, including subject compensation, confidentiality of subjects and their records, and the operation of ethics committees. Such issues and more detailed clinical trial design guidelines can be found in YY/T 0297.