YY/T 1681-2019 English PDF (YYT1681-2019)

This Standard defines the basic terms and definitions of unique device identification system.

YY/T 1681-2019
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.01; 35.040
C 30
Basic terms of unique device identification system
ISSUED ON: JULY 24, 2019
IMPLEMENTED ON: AUGUST 01, 2020
Issued by: National Medical Products Administration
Table of Contents
Foreword ... 3
1 Scope ... 4
2 General terms ... 4
3 Unique device identifier ... 5
4 Unique device identifier data carrier ... 6
5 Unique device identification database ... 6
Bibliography ... 7
Foreword
This Standard is drafted in accordance with the rules given in GB/T 1.1-2009. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. The issuing authority of this document shall not be held responsible for identifying any or all such patent rights.
This Standard was proposed by National Medical Products Administration. This Standard shall be under the jurisdiction of National Institutes for Food and Drug Control.
Drafting organizations of this Standard: National Institutes for Food and Drug Control, Chinese PLA General Hospital, Shanghai MicroPort Medical (Group) Co., Ltd., Abbott Trading (Shanghai) Co., Ltd.
Main drafters of this Standard: Yi Li, Yu Xinhua, He Kunlun, Mu Ruihong, Zheng Jia, Li Yong, Qu Lei, Wang Jian.
Basic terms of unique device identification system
1 Scope
This Standard defines the basic terms and definitions of unique device
identification system.
2 General terms
2.1 Unique device identification system; UDI system
The unified medical device identification system which consists of unique device identifier, unique device identifier data carrier, and unique device identification database.
2.2 Label
The text descriptions, graphics, and symbols, attached to medical devices or their packaging, which are used to identify product characteristics and indicate information such as safety warnings.
2.3 Labelling
Labels, instructions for use, and any other information related to the
identification, technical description, intended use, and correct use of medical devices, but not including shipping documents.
[YY/T 0287-2017, definition 3.8]
2.4 Direct marking
A method of permanently attaching a unique device identifier to the body of a medical device.
2.5 Shipping container
The packaging by which logistics system process controls product traceability. 2.6 Packaging level
Different levels of medical device packaging, which contains a fixed number of medical devices.
Note: It does not include shipping container.