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YY/T 1681-2019

Chinese Standard: 'YY/T 1681-2019'
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BASIC DATA
Standard ID YY/T 1681-2019 (YY/T1681-2019)
Description (Translated English) Basic terms of unique device identification system
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C30
Classification of International Standard 11.040.01; 35.040
Word Count Estimation 6,683
Date of Issue 2019-07-24
Date of Implementation 2020-08-01
Drafting Organization China Food and Drug Administration Institute, People's Liberation Army General Hospital, Shanghai MicroPort Medical Devices (Group) Co., Ltd., Abbott Trade (Shanghai) Co., Ltd.
Administrative Organization China Institute of Food and Drug test
Proposing organization State Drug Administration
Issuing agency(ies) State Drug Administration

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
医疗器械唯一标识系统基础术语
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.

YY/T 1681-2019
Basic terms of unique device identification system
ICS 11.040.01; 35.040
C30
People's Republic of China Pharmaceutical Industry Standard
Basic terminology of medical device unique identification system
2019-07-24 release
2020-08-01 implementation
Issued by the State Drug Administration
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
Please note that some content of this document may involve patents. Publication of this document
The institution does not assume responsibility for identifying these patents.
This standard was proposed by the State Drug Administration.
This standard is under the jurisdiction of the China Food and Drug Administration.
This standard was drafted by. China Food and Drug Administration, Chinese People's Liberation Army General Hospital, Shanghai Minimally Invasive Medical Devices (Group)
Limited company, Abbott Trading (Shanghai) Co., Ltd.
The main drafters of this standard. Yi Li, Yu Xinhua, He Kunlun, Mu Ruihong, Zheng Jia, Li Yong, Qu Lei, Wang Jian.
Basic terminology of medical device unique identification system
1 Scope
This standard defines the basic terms and definitions of the unique identification system for medical devices.
2 General terms
2.1
Unique device identification system for medical devices; UDIsystem
A medical device system consisting of a unique medical device identification, a medical device unique identification data carrier, and a medical device unique identification database
One identification system.
2.2
Label
Text descriptions and graphics for identifying product features and indicating safety warnings and other information attached to medical devices or their packaging,
symbol.
2.3
Labeling
Labels, instructions and any other information related to the identification, technical description, intended use and proper use of medical devices, but not
Include shipping documents.
[YY/T 0287-2017, definition 3.8]
2.4
Ontology direct marking
A method of permanently attaching a unique identification of a medical device to the body of a medical device.
2.5
Shipping packaging shippingcontainer
The packaging of product traceability is controlled by the logistics system process.
2.6
Product packaging level
Different levels of medical device packaging, which contains a fixed number of medical devices.
Note. Transport packaging is not included.
3 Unique identification of medical devices
3.1
Unique device identifier for medical devices; UDI
A series of codes composed of numbers, letters and/or symbols created based on standards, including product identification and production identification, used for medical treatment
The device is uniquely identified.
Note 1.The word "unique" does not mean serial management of individual products.
Note 2.Can be used for the management and traceability of medical device products.
3.2
Product identifier deviceidentifier; UDI-DI
A unique code specific to a specific model and packaged medical device.
Note. The product identification can be used as an "access keyword" for information stored in the database of the unique identification of medical devices, associated with medical device product information, manufacturer information,
Registration information, etc.
3.3
Production identifier; UDI-PI
A code to identify data related to the medical device manufacturing process.
Note. According to the actual application requirements, the production label may include the serial number of the medical device, the production batch number, the production date, the expiration date, etc.
3.4
Data delimiter
In the unique identification of medical devices, define the character or character set of specific data elements.
Note. Examples of data separators are application identifier (AI), object identifier (OID), etc.
3.5
Use unit product identification unitofusedeviceidentifier; UoUUDI-DI
When there is no unique medical device identification on the medical device use unit, the product identification assigned to a single medical device product, its
The purpose is to associate patients with medical devices.
Note. For example, a package of N blood collection tubes (N>1). If a single blood collection tube does not have a unique medical device identification, the product identification assigned to a single blood collection tube.
4 Medical device unique identification data carrier
4.1
Uniquedeviceidentifierdatacarrier
A data medium that stores or transmits the unique identification of medical devices.
4.2
One-dimensional barcode
Barcode symbols that represent information only in one dimension.
[GB/T 12905-2000, definition 2.53]
4.3
Two-dimensional barcode
Barcode symbols representing information in both directions.
[GB/T 12905-2000, definition 2.54]
4.4
Radio Frequency Identification; RFID
In the radio frequency part of the spectrum, electromagnetic coupling or inductive coupling is used to communicate with the radio frequency tag through various modulation and coding schemes.
A technology to read the identity of the radio frequency tag.
[GB/T 29261.3-2012, definition 05.01.01]
4.5
RF tag
Used for object or item identification, with information stora......
Related standard: YY/T 1686-2020
Related PDF sample: YY/T 1630-2018    YY/T 1512-2017