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YY/T 1752-2020 PDF English

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YY/T 1752-2020: Basic Data Set of Unique Device Identification Database
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YY/T 1752-2020: Basic Data Set of Unique Device Identification Database

---This is an excerpt. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.), auto-downloaded/delivered in 9 seconds, can be purchased online: https://www.ChineseStandard.net/PDF.aspx/YYT1752-2020
YY PHARMACEUTICAL INDUSTRY STANDARD ICS 11.040; 35.240.01 C 30 Basic Data Set of Unique Device Identification Database Issued on. JUNE 30, 2020 Implemented on. OCTOBER 01, 2020 Issued by. National Medical Products Administration

Table of Contents

Foreword... 3 1 Scope... 4 2 Normative References... 4 3 Terms and Definitions... 4 4 Abbreviations... 4 5 Category of Basic Data Subset of Unique Device Identification Database... 5 6 Description Data Item... 5 7 Relevant Data Subset of the Basic Information of the Unique Device Identification Database... 7 8 Relevant Data Subset of the Unique Device Identification Coding Institution Information... 8 Appendix A (Normative) Range Code List... 24 Appendix B (Normative) Instructions of Location Values... 25 Bibliography... 26

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. This Standard was proposed by National Medical Products Administration. This Standard shall be under the jurisdiction of Information Centre of National Medical Products Administration. Drafting organizations of this Standard. Information Centre of National Medical Products Administration; China National Institute of Standardization; and Chinese PLA General Hospital. Chief drafting staffs of this Standard. Chen Feng, Guo Yuanyuan, Zhang Yuan, He Kunlun, Liu Liang, Zhang Wensi, Li Dandan, Liu Peng, and Li Qiang. Basic Data Set of Unique Device Identification Database

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. ......

Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.
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