YY/T 1752-2020Basic data set of unique device identification database (English PDF)
医疗器械唯一标识数据库基本数据集
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
June 30, 2020
Implementation date
October 1, 2020
Scope
YY/T 1752-2020 is the English-translated version of 医疗器械唯一标识数据库基本数据集.
YY/T 1752-2020 is the Chinese pharmaceutical industry standard that defines the basic data set of the unique device identification database: the categories of data it holds, the subsets within them and the content of each field, that is what a manufacturer must record about a device model and its production data so that the identifier can be resolved.
It is used in building and maintaining such a database. Issued on 30 June 2020, it has applied since 1 October 2020.
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Document preview — YY/T 1752-2020
National Standard of the People's Republic of China
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Foreword3
- 1 Scope4
- 2 Normative References4
- 3 Terms and Definitions4
- 4 Abbreviations4
- 5 Category of Basic Data Subset of Unique Device Identification Database5
- 6 Description Data Item5
- 7 Relevant Data Subset of the Basic Information of the Unique Device Identification Database7
- 8 Relevant Data Subset of the Unique Device Identification Coding Institution Information8
- Appendix A (Normative) Range Code List24
- Appendix B (Normative) Instructions of Location Values25
- Bibliography26
Foreword
This Standard was drafted as per the rules specified in GB/T 1.1-2009.
Please note some contents of this document may involve patents. The issuing agency of this document shall not assume the responsibility to identify these patents.
1 Scope
This Standard specifies the categories and data subsets and the like contents of the basic data sets of unique device identification database.
This Standard is applicable to the construction of a unique device identification database.
2 Normative References
The following documents are essential to the application of this document. For the dated documents, only the versions with the dates indicated are applicable to this document; for the undated documents, only the latest version (including all the amendments) is applicable to this document.
GB/T 2260 Codes for the Administrative Divisions of the Peoples Republic of China
GB/T 7408 Data Elements and Interchange Formats - Information Interchange - Representation of Dates and Times
YY/T 1681 Basic Terms pf Unique Device Identification System
3 Terms and Definitions
For the purposes of this document, the following terms and definitions given in YY/T 1681 apply.
3.1 Direct marking UDI-DI
The medical device body is directly attached with the product identification in the unique device identification.
4 Abbreviations
The following abbreviations are applicable to this document.
5 Category of Basic Data Subset of 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, the contact information of the device registrant/filer, and the data subset of the unique device identification coding institution information. The specific categories are shown in Table 1.
6 Description Data Item
6.1 Short name of data item
The Chinese Pinyin acronym of the Chinese name of the data item (ignoring the symbol) is used as the field name in the construction of the unique device identification database.
6.2 Description of data item
Describe the definition or purpose of the data item.
6.3 Data type
It represents the symbols, characters or other types of data items, see Table 2.
7 Relevant Data Subset of the Basic Information of the Unique Device Identification Database 7.1 Data subset of the basic information of the unique device identification database The data subset of the basic information of the unique device identification database mainly includes. basic information of product identification, basic information of product, packaging product identification and its packaging level association information, basic information of clinical use, etc., see Table 4 for details, of which.
8 Relevant Data Subset of the Unique Device
Identification Coding Institution Information The data subset of the unique device identification coding institution information mainly includes. the basic information of the issuing agency, and the basic information of the relevant contact person.
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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 26 pages — is available in the English PDF.
Referenced standards
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Related Standards
GB/T 2260-2007 — Codes for the administrative divisions of the People's Republic of China
GB/T 7408.1-2023 — Date and time - Representations for information interchange - Part 1: Basic rules
GB/T 7408.2-2025 — Date and time - Representation for information interchange - Part 2: Extensions
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