YY/T 1942-2024 English PDF (YYT1942-2024)

Delivery: 3 seconds. Download true-PDF + Invoice.
Get Quotation: Click YY/T 1942-2024 (Self-service in 1-minute)
Historical versions (Master-website): YY/T 1942-2024
Preview True-PDF (Reload/Scroll-down if blank)

YY/T 1942-2024: Form and content of the unique device identifier
YY/T 1942-2024
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.040
CCS C 30
Form and Content of Unique Device Identifier
ISSUED ON: JULY 8, 2024
IMPLEMENTED ON: JULY 20, 2025
Issued by: National Medical Products Administration
Table of Contents
Foreword ... 3
Introduction ... 4
1 Scope ... 5
2 Normative References ... 5
3 Terms, Definitions and Abbreviations ... 5
4 Form of UDI ... 6
5 Content of UDI ... 7
6 Data Separator ... 7
7 UDI Parsing ... 8
Appendix A (Informative) Comparison of 1D Code, 2D Code and RFID ... 16
Appendix B (Informative) Considerations for Selecting AIDC Readers in IMDRF
UDI Application Guide ... 17
Bibliography ... 18
Form and Content of Unique Device Identifier
1 Scope
This Document specifies the form and content of the unique device identifier, data separators
and the parsing of unique identifier.
This Document is applicable to the implementation and application of unique device identifier
by all relevant parties.
2 Normative References
The provisions in following documents become the essential provisions of this Document
through reference in 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 1681 Basic terms of unique device identification system
YY/T 1943 UDI implementation and application in medical device package levels
3 Terms, Definitions and Abbreviations
3.1 Terms and definitions
For the purposes of this Document, the terms and definitions given in YY/T 1681 apply.
3.2 Abbreviations
The following abbreviations are applicable to this Document.
AIDC: Automatic Identification and Data Capture
HRI: Human Readable Information
RFID: Radio Frequency Identification
UDI: Unique Device Identifier
UDID: Unique Device Identification Database
4.2.4 Manufacturers should consider guiding the AIDC carrier containing the UDI in an
appropriate manner, such as using the UDI graphic symbol in Clause 5 d) of YY/T 1879-2022.
4.2.5 A comparison of the three common AIDC forms, 1D code, 2D code and RFID, is shown
in Appendix A. For the selection of AIDC readers, please refer to the considerations for
selecting AIDC readers in the IMDRF UDI application guide, see Appendix B.
4.3 HRI
4.3.1 HRI enables medical staff, patients, regulatory agencies and other users of the UDI system
to read UDIs without technical assistance and enter them into data systems (such as medical
records or reports submitted to regulatory agencies). It should serve as an additional mechanism
for collecting UDIs when the AIDC carrier form cannot be read.
4.3.2 HRI shall contain UDI-DI and UDI-PI parts, as well as corresponding data separators.
4.3.3 HRI can be displayed as single-line or multi-line text. Single data fields (data separators
and their defined information fields) shall not wrap and shall be displayed below or near the
AIDC.
4.3.4 The form of HRI shall meet the coding rules of the code-issuing agency.
5 Content of UDI
5.1 The content of UDI in this Document refers to the data information contained in UDI and
its corresponding HRI and AIDC forms.
5.2 UDI includes UDI-DI and UDI-PI, among which the production batch number, serial
number, production date, expiration date, and version number of independent software belong
to UDI-PI. If otherwise specified by national laws and regulations and standards, they shall
prevail.
5.3 It is not recommended that manufacturers add other content other than UDI information
(UDI-DI and UDI-PI), such as quantity, to the UDI data carrier. If it is necessary to add, it shall
comply with relevant laws and regulations and the relevant rules and requirements of the code-
issuing agency; and its data separator shall be distinguished from the data separators of UDI-
DI and UDI-PI.
5.4 The order of data in the data carrier shall follow the rule that UDI-DI is placed before UDI-
PI and UDI-PI is placed before other content.
6 Data Separator
6.1 Data separators are characters or character sets that define specific data information and are
used to identify specific data information content in the encoded data string.
A – product identifier;
B – product name;
C – specification and model;
D – registration certificate No.;
E – registered/recorded by;
F – production batch number;
G – production date;
H – expiration date;
I – unit;
J – quantity;
K – syringe;
L – GXZZ.
NOTE 1: In this method, it needs to manually enter the UDI-PI field and complete UDI information.
NOTE 2: Other required content shall be filled in the corresponding link according to the needs.
Figure 4 – A diagram of using HRI method to obtain relevant information in UDID by
searching and selecting UDI-DI
d) According to the rules and formats of the involved code-issuing agencies, parse the UDI into
UDI-DI and the corresponding UDI-PI; and fill in the corresponding fields of the system,
respectively.
NOTE 3: For other contents in the data carrier (if any), parse and record them according to the
definitions provided in 6.3 as needed.
e) Perform necessary information correctness checks according to the rules of the code-issuing
agency, and prompt any found errors.
f) Perform UDID association search and data information extraction through UDI-DI online or
local storage. If through local storage, consider docking with UDID to obtain version update
information.
g) According to YY/T 1943, establish the conversion relationship of UDI-DI identification
quantity for different product packaging levels.
Appendix B
(Informative)
Considerations for Selecting AIDC Readers in IMDRF UDI
Application Guide
AIDC readers include barcode readers and other reading devices, such as RFID readers.
Barcode readers are designed and manufactured in a variety of forms (e.g., fixed, handheld,
wired, wireless, wearable, mobile phones, etc.); and like many electronic devices, they are
available from a variety of manufacturers; and users can choose their own features and functions.
Barcode readers include laser readers that can only read 1D codes (such as 128 barcodes) and
imaging readers that can read 1D and 2D codes simultaneously (such as 128 barcodes and data
matrix codes).
It is recommended that users use imaging readers in UDI applications to scan 1D and 2D codes
simultaneously. Any evaluation of readers or reader technologies shall take into account the
range of barcode formats, sizes, and depth of field that are scanned at the point of care. It is
recommended that readers be able to read 2D codes printed on traditional labels and 2D codes
marked directly on implants or other medical devices.
No additional technical knowledge is required to use a 2D/matrix code reader compared with a
1D code reader. The omnidirectional reading capabilities of 2D/matrix code image readers, as
well as their inherent ability to read both 2D/matrix and 1D codes, make them easier to use and
more cost-effective in the long run. The only technical consideration is that each reader shall
be properly set up/configured for its intended use, which is usually easily accomplished by the
manufacturer providing the reader.
Readers for UDI applications support barcode symbology that complies with relevant
international standards, including ISO/IEC 16022, ISO/IEC 18004, ISO/IEC 15417, ISO/IEC
15420.
Standardized barcode symbology has symbol identifiers registered in ISO/IEC 15424. Barcode
readers send symbol identifiers to distinguish data carriers for each code-issuing agency.
Other examples of reading devices are RFID readers. Some current RFID readers can also read
1D and 2D codes. However, barcode readers usually cannot read RFID tags without the addition
of an RFID reader.