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This standard is developed in accordance with the rules given in GB/T 1.1-2009.
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This standard was proposed by the National Medical Products Administration.
This standard is under the jurisdiction of the National Medical Products Administration.
Basic data set of unique device identification database
1 Scope
This standard specifies the categories, data subsets and other related contents of basic data sets involved in the unique device identification database.
This standard is applicable to the construction of unique device identification database.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
GB/T 2260 Codes for the administrative divisions of the People’s Republic of China
GB/T 7408 Data elements and interchange formats - Information interchange - Representation of dates and times
YY/T 1681 Basic terms of unique device identification system
3 Terms and definitions
For the purposes of this standard, the terms and definitions established in YY/T 1681 as well as the followings apply.
3.1
direct marking UDI-DI
marking that the medical device body is directly applied with the unique device identifier.
4 Abbreviations
For the purposes of this document, the following abbreviations apply.
UDI: Unique Device Identifier
UDI-DI: Device Identifier
MR: Magnetic Resonance
5 Basic data subset categories of the unique device identification database
The basic data set of the unique device identification database mainly includes the basic information of the unique device identification database, contact information of medical device registrant/filer, and data subset of the information of the UDI coding institution. See Table 1 for specific categories.
Table 1 Basic data subset categories of the unique device identification database
S.N. Data subset category Data subset
1 Data subset related to basic information of the unique device identification database Data subset of basic information of the unique device identification database
Data subset of contact information of medical device registrant/filer
2 Data subset related to the information of the unique device identifier coding institution Data subset of the information of the unique device identifier coding institution
6 Description of data item
6.1 Short name of data item
Initials of Chinese phonetic alphabets of Chinese names (ignoring symbols) of data items are used as field names in the construction of the unique device identification database. If there is a data item with the same short name in a data subset, the following treatment principle shall be followed: start with the first repeated short name, add two sequence numbers after the short name, and the sequence numbers will increase from 01.
6.2 Description of data source
The definition or purpose of the data item shall be described.
6.3 Data type
See Table 2 for symbols, characters or other types of data items.
Foreword i
1 Scope
2 Normative references
3 Terms and definitions
4 Abbreviations
5 Basic data subset categories of the unique device identification database
6 Description of data item
7 Data subset related to basic information of the unique device identification database
8 Data subset related to information of the unique device identifier coding institution
Annex A (Normative) Value range code table
Annex B (Normative) Description of location values
Bibliography
