YY/T 1956-2025 Active Industry standards-Medicine

YY/T 1956-2025 Clinical investigation of in vitro diagnostic reagents—Terms and definitions

Publish Date: 2025-02-26 Implement Date: 2026-03-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY/T 1956-2025

Standard Type: Industry standards

Standard Status: Active

is_force_gb: no

CCS Name: Medical devices

ICS Name: -

Publish Date: 2025-02-26

Implement Date: 2026-03-01

Pages: 16 pages

Scope

This document defines the terms and definitions related to the clinical trials of in vitro diagnostic reagents, including those used in the design, implementation, recording, and reporting of in vitro diagnostic reagent clinical trials. The in vitro diagnostic reagents referred to in this document are those subject to the management of medical devices as in vitro diagnostic reagents.
This document is applicable to the clinical trials of in vitro diagnostic reagents.