YY/T 1997-2026 Pending Industry standards-Medicine

YY/T 1997-2026 Management requirements for specimen in clinical studies of IVD reagents

Publish Date: 2026-03-09 Implement Date: 2027-03-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY/T 1997-2026

Standard Type: Industry standards

Standard Status: Pending

is_force_gb: no

CCS Name: Medical devices

ICS Name: Medical equipment

Publish Date: 2026-03-09

Implement Date: 2027-03-01

Publisher: 国家药品监督管理局

Technical Committee: 全国医疗器械临床评价标准化技术归口单位

Pages: 12 pages

Scope

本文件规定了体外诊断（IVD）试剂临床试验过程中人体生物样本管理的总体要求、保密性要求、伦理要求和样本采集、收集、运送及接收、保存、前处理、检测、处置、生物安全文件和记录的要求。
本文件适用于以注册为目的的体外诊断试剂临床试验。

Development Information

Drafting Units:

国家药品监督管理局医疗器械技术审评中心

Drafting Persons:

何静云、郑生伟、李晓丽

Word Count: 13 Thousand words Pages: 12 pages

Referenced Standards

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

Related Standards

GB 9706.8-1995 Replaced

GB 9706.8-1995 Medical electrical equipment—Part 2:Particular requirements for the safety of cardiac defibrillators and cardiac defibrillator-monitors

Publish Date: 1995-06-02

GB 11235-1997 Replaced

GB 11235-1997 VCu intra-uterine device

Publish Date: 1997-07-24

GB/T 17257.1-1998 Replaced

GB/T 17257.1-1998 Urine collection bags—Part 1:Vocabulary

Publish Date: 1998-03-18

GB/T 17257.2-1998 Replaced

GB/T 17257.2-1998 Urine collection bags—Part 2:Determination of dimensions

Publish Date: 1998-03-18

GB/T 17257.3-1998 Replaced

GB/T 17257.3-1998 Urine collection bags—Part 3:Verification of rated volume

Publish Date: 1998-03-18

GB/T 17257.4-1998 Replaced

GB/T 17257.4-1998 Urine collection bags—Part 4:Determination of freedom form leakage

Publish Date: 1998-03-18