YY/T 1942-2024 Form and content of the unique device identifier
1 Scope
This document specifies the form and content of the unique device identifier, the data delimiter and the resolution of the unique identifier.
This document is applicable to all interested parties to implement and apply the unique device identifier.
2 Normative references
The following documents contain provisions which, through reference in this text, constitute provisions 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.
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
For the purposes of this document, the following abbreviations apply.
AIDC: Automatic Identification and Data Capture
HRI: Human Readable Information
RFID: Radio Frequency Identification
UDI: Unique Device Identifier
UDID: Unique Device Identification Database
UDI-DI: Unique Device Identifier-Device Identifier
UDI-PI: Unique Device Identifier-Production Identifier
4 Form of the UDI
4.1 General
4.1.1 The form of the UDI in this document refers to the way in which the UDI is presented as a data carrier on medical device labels, packaging, or products.
4.1.2 The AIDC and HRI parts of the data carrier shall not be replaced with other label information. The relationship between the form of UDI data carrier including AIDC and HRI and other label information is shown in Figure 1.
Foreword i
Introduction ii
1 Scope
2 Normative references
3 Terms, definitions and abbreviations
4 Form of the UDI
5 Content of the UDI
6 Data delimiters
7 Resolution of the UDI
Annex A (Informative) Comparison of one-dimensional bar code, two-dimensional bar code and RFID
Annex B (Informative) Considerations for selecting an AIDC reader in the IMDRF UDI Application Guide
Bibliography
