YY/T 2000-2026 Pending Industry standards-Medicine

YY/T 2000-2026 Medical device real world data—Terms and definitions

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 2000-2026

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: 16 pages

Scope

本文件界定了医疗器械真实世界数据涉及的术语和定义，包括医疗器械真实世界研究过程中使用的术语和定义。
本文件适用于医疗器械临床评价。

Development Information

Drafting Units:

国家药品监督管理局医疗器械技术审评中心、海南乐城真实世界研究院、新型生物材料与高端医疗器械广东研究所、国家药品监督管理局医疗器械技术审评检查大湾区分中心

Drafting Persons:

崔馨月、卢红、滕颖影、程玮璐、刘露、刘英慧、贾健雄、袁玮鸿、庄小洁、张译丹、蔡霜霜

Word Count: 19 Thousand words Pages: 16 pages

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