YY/T 1942-2024 Active Industry standards-Medicine

YY/T 1942-2024 Form and content of the unique device identifier

Publish Date: 2024-07-08 Implement Date: 2025-07-20 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY/T 1942-2024

Standard Type: Industry standards

Standard Status: Active

is_force_gb: no

CCS Name: Medical devices

ICS Name: Medical equipment

Publish Date: 2024-07-08

Implement Date: 2025-07-20

Publisher: 国家药品监督管理局

Technical Committee: 国家药品监督管理局医疗器械标准管理中心

Pages: 20 pages

Scope

本文件规定了医疗器械唯一标识的形式和内容、数据分隔符和唯一标识的解析。
本文件适用于各相关方实施和应用医疗器械唯一标识。

Development Information

Drafting Units:

国家药品监督管理局医疗器械标准管理中心、通用电气医疗系统贸易发展(上海)有限公司、深圳迈瑞生物医疗电子股份有限公司、天津市药品监督管理局、中国人民解放军总医院、山东省医疗器械和药品包装检验研究院、北京大学第三医院、中国医疗器械有限公司

Drafting Persons:

易力、崔骏、汪新兵、杜茗勋、何昆仑、刘斌、徐超楠、赵宇、吕原原、赵燕、周娟

Word Count: 23 Thousand words Pages: 20 pages

Referenced Standards

YY/T 1681-2019 Basic terms of unique device identification system YY/T 1943-2024 UDI implementation and application in medical device package levels

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