YY/T 1681-2019Basic terms of unique device identification system (English PDF)

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.

Different levels of medical device packaging, which contains a fixed number of medical devices.

Note. It does not include shipping container.

3.1 Unique device identifier; UDI

A series of codes composed of numbers, letters and/or symbols created based on standards, including device identifier and production identifier, which are used to uniquely identify medical devices.

3.2 Device identifier; UDI-DI

A unique code specific to a certain specification model and packaged medical device.

3.4 Data delimiter

Characters or character sets which define specific data elements in the unique device identifier.

Note. Examples of data delimiters are application identifier (AI), object identifier (OID), etc.

3.5 Unit of use device identifier; UoU UDI-DI

The device identifier assigned to a single medical device product when there is no unique device identifier on the medical device use unit, the purpose of which is to associate patients with medical devices.

4.1 Unique device identifier data carrier

The data medium which stores or transmits the unique device identifier.

4.2 One-dimensional bar code

The bar code symbol which represents information only in one-dimensional direction.

4.3 Two-dimensional bar code

The bar code symbol which represents information in two-dimensional direction.

4.4 Radio frequency identification; RFID

The technique to communicate with the radio frequency tag interactively and to uniquely read the identity of radio frequency tag, through various modulation and coding schemes, using electromagnetic coupling or inductive coupling in the radio frequency part of the spectrum. [GB/T 29261.3-2012, definition 05.01.01]

5.1 Unique device identification database; UDID

The database which stores UDI-DI and associated information.