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YY/T 1753-2020 PDF English

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YY/T 1753-2020: Reporting Guide of Unique Device Identification Database
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YY/T 1752   YY/T 1754.1   YY/T 1754.2   YY/T 1754.4   

YY/T 1753-2020: Reporting Guide 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/YYT1753-2020
YY PHARMACEUTICAL INDUSTRY STANDARD ICS 11.040; 35.240.01 C 30 Reporting Guide 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 Reporting Mode of Data... 5 6 Requirements for Data Interface Exchange Format... 5 7 Content of Data Reporting... 12 8 Security Requirements for Data Reporting... 12 Appendix A (Informative) Reporting Example Instructions of the Basic Information of Unique Device Identification Database... 13 Appendix B (Informative) Example of Interface Format for Data Reporting of Unique Device Identification Database... 17 Bibliography... 19

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, Li Qiang, and Liu Peng. Reporting Guide of Unique Device Identification Database

1 Scope

This Standard specifies the basic requirements for reporting the product identification and related information to the unique device identification database (referred to database for short). This Standard is applicable to the reporting of the 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. YY/T 1752-2020 Basic Data Set of Unique Device Identification Database

3 Terms and Definitions

For the purposes of this document, the following terms and definitions given in YY/T 1752-2020 apply.

4 Abbreviations

The following abbreviations are applicable to this document.

5 Reporting Mode of Data

It may be reported by three modes. webpage reporting, data template import and data interface exchange.

6 Requirements for Data Interface Exchange Format

6.1 XML format When using the XML format to transmit the data records corresponding to the database basic information data subset, the data records shall be described as the udid element. The XML format rules of the udid element are shown in Figure 1, and the specific description can refer to B.1, where.

7 Content of Data Reporting

The content of data reporting for the unique device identification database shall include the content of 7.1 in YY/T 1752-2020.

8 Security Requirements for Data Reporting

8.1 Access authentication During data transmission, the database shall authenticate the applicant and verify the corresponding request authority. 8.3 Transmission security Data transmission shall use a secure transmission protocol. 8.4 Message status receipt During data exchange, the database shall return a message status receipt containing the processing result to the applicant. ......
Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.


      

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