YY/T 1943-2024 Active Industry standards-Medicine

YY/T 1943-2024 UDI implementation and application in medical device package levels

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 1943-2024

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的各产品包装级别包装的唯一标识实施和在供应链中的解析。
本文件适用于多级包装医疗器械产品唯一标识的实施和应用。

Development Information

Drafting Units:

国家药品监督管理局医疗器械标准管理中心、中国人民解放军总医院、通用电气医疗系统贸易发展(上海)有限公司、中国医疗器械有限公司、北京大学第三医院、上海中医药大学附属龙华医院、山东省医疗器械和药品包装检验研究院、上药医疗器械(上海)有限公司、威海威博医疗科技有限公司

Drafting Persons:

易力、汤京龙、何昆仑、姜洁、赵宇、薛昕昀、沈磊、张丽梅、张颎、李君、吕原原、曹德森

Word Count: 18 Thousand words Pages: 20 pages

Referenced Standards

YY/T 1681-2019 Basic terms of unique device identification system YY/T 1752-2020 Basic data set of unique device identification database YY/T 1753-2020 Reporting guide of unique device identification database YY/T 1942-2024 Form and content of the unique device identifier

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