YY/T 1630-2018 English PDF (YYT1630-2018)

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YY/T 1630-2018: Fundamental requirements for unique device identifier
YY/T 1630-2018
(Basic requirements for unique identification of medical devices)
ICS 11.040.01; 35.040
C30
People's Republic of China Pharmaceutical Industry Standard
Basic requirements for unique identification of medical devices
Published on.2018-12-20
2020-01-01 implementation
State Drug Administration issued
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
Please note that some of the contents of this document may involve patents. Publication of this document
The organization does not assume responsibility for identifying these patents.
This standard was proposed by the State Drug Administration.
This standard is under the jurisdiction of the former Medical Device Standards Management Center of the State Food and Drug Administration.
This standard was drafted. former Medical Device Standards Management Center of the State Food and Drug Administration and the People's Liberation Army General Hospital.
The main drafters of this standard. Yi Li, Yu Xinhua, He Kunlun, Ma Ruihong, Zheng Jia, Xu Huiwen, Wang Jian.
Basic requirements for unique identification of medical devices
1 Scope
This standard specifies the relevant terms and definitions, basic principles, product identification requirements and production identification of the unique identification of medical devices.
Claim.
This standard applies to the management of the unique identification of medical devices.
2 Normative references
The following documents are indispensable for the application of this document. For dated references, only the dated version applies to this article.
Pieces. For undated references, the latest edition (including all amendments) applies to this document.
GB/T 1988 Seven-digit coded character set for information technology information exchange
YY/T 0287 Medical Device Quality Management System for Regulatory Requirements
3 Terms and definitions
The following terms and definitions as defined by YY/T 0287 apply to this document.
3.1
Medical device unique identifier uniquedeviceidentifier
A series of codes, numbers, and/or symbols created based on standards, including product identification and production identification, for medical use
The device is uniquely identified.
Note 1. The term “unique” does not imply serialization of a single product.
Note 2. It can be used for the management and traceability of medical device products.
Note 3. Currently UDI is commonly used internationally to represent uniquedeviceidentifier.
3.2
Product identification deviceidentifier
A unique code that is specific to a particular model and packaged medical device.
Note 1. The product identification can be used as an “access keyword” for information stored in the unique identification database of the medical device, associated medical device product information, manufacturer information,
Registration information, etc.
Note 2. UDI-DI is currently used internationally to represent deviceidentifier.
3.3
Production identifier productionidentifier
A code that identifies data related to the manufacturing process of a medical device.
Note 1. According to the actual application requirements, the production identification may include the medical device serial number, production batch number, production date, expiration date, and the like.
Note 2. UDI-PI is currently used internationally to indicate productionidentifier.
3.4
Data separator datadelimiter
In a medical device unique identifier, a character or character set that defines a particular data element.
Note. Examples of data separators are Application Identifier (AI), Object Identifier (OID), and so on.