Codeofchina.com is in charge of this English translation. In case of any doubt about the English translation, the Chinese original shall be considered authoritative.
This standard is developed in accordance with the rules given in GB/T 1.1-2009.
Attention is drawn to the possibility that some of the elements of this standard may be the subject of patent rights. The issuing body of this document shall not be held responsible for identifying any or all such patent rights.
This standard was proposed by the National Medical Products Administration of the People’s Republic of China (NMPA).
This standard is under the jurisdiction of the NMPA, Center for Medical Devices Standardization Administration.
Fundamental requirements for unique
device identifier
1 Scope
This standard specifies the terms and definitions, basic principles, device identifier requirements and production identifier requirements for unique device identifier.
This standard is applicable to the management of unique device identifier.
2 Normative references
The following referenced documents are indispensable for the application 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.
GB/T 1988 Information technology — 7-bit Coded character set for information interchange
YY/T 0287 Medical devices — Quality management systems — Requirements for regulatory purposes
3 Terms and definitions
For the purposes of this standard, the terms and definitions given in YY/T 0287 and the followings apply.
3.1
unique device identifier
a series of codes consisting of numbers, letters and/or symbols created based on standards for uniquely identifying medical devices, including device identifier and production identifier
Note 1: The word "unique" does not indicate serialization management to a single product.
Note 2: It may be used for the management and traceability of medical device products.
Note 3: UDI is now used internationally to indicate “unique device identifier”.
3.2
device identifier
unique code specific to a certain specification, model and packaged medical device
Note 1: The device identifier may be used as the "access key" for the information stored in the unique identifier database of medical devices, which is associated with the product information, manufacturer information and registration information of medical devices.
Note 2: UDI-DI is now used internationally to indicate “device identifier”.
3.3
production identifier
code for identifying data in the medical device production process
Note 1: According to the actual application requirements, the production identifier may include the serial number, production batch number, production date and expiration date of medical devices.
Note 2: UDI-PI is now used internationally to indicate “production identifier”.
3.4
data delimiter
characters or character sets that define specific data elements in the unique device identifier
Note: Examples of data delimiter are application identifier (AD), object identifier (OID), etc.
4 Basic principles of unique device identifier
Basic principles of unique device identifier are:
a) The characters used shall conform to GB/T 1988 or relevant international standards;
Note: An example of such relevant international standards is ISO/IEC 646.
b) The unique device identifier shall be unique at the level of specifications, models, batches or individual products of medical devices. For medical devices with same characteristics, the uniqueness of the unique device identifier shall refer to a single specification and model product. For medical devices controlled by batch production, the uniqueness of the unique device identifier shall refer to the same batch of products. For medical devices controlled by serial number production, the uniqueness of the unique device identifier shall refer to a single product. This may be achieved by complying with international standards, such as ISO/IEC 15459-4 and ISO/IEC 15459-6, or by other appropriate means;
c) According to the specific using conditions, there shall be a corresponding verification mechanism, which is obtained by the standard algorithm, to verify the correctness of the whole or component of the unique device identifier;
d) The unique device identifier shall be as short as possible;
e) Data delimiter shall be included to ensure that all components of device identifier and production identifier can be correctly read and interpreted.
See Annex A for the structural schematic diagram of the unique device identifier.
5 Device identifier requirements
Specific requirements for device identifier are as follows:
a) It shall be able to identify the information of medical device manufacturers and the devices;
b) It shall be unique on all levels of device packaging (see Annex B).
6 Production identifier requirements
Production identification shall be used in combination with device identification, and its composition shall be determined according to device identification requirements;
a) If the medical device batch needs to be identified, the production batch number shall be included;
b) If the individual products of medical devices need to be identified, the serial number shall be included;
c) if the production date of medical devices needs to be identified, the production date shall be included;
d) If the expiration date of medical devices needs to be identified, the expiration date shall be included.
Foreword i 1 Scope 2 Normative references 3 Terms and definitions 4 Basic principles of unique device identifier 5 Device identifier requirements 6 Production identifier requirements Annex A (Informative) Structural schematic diagram of the unique device identifier Annex B (Informative) Packaging schematic of device identifier and medical device Bibliography
Codeofchina.com is in charge of this English translation. In case of any doubt about the English translation, the Chinese original shall be considered authoritative.
This standard is developed in accordance with the rules given in GB/T 1.1-2009.
Attention is drawn to the possibility that some of the elements of this standard may be the subject of patent rights. The issuing body of this document shall not be held responsible for identifying any or all such patent rights.
This standard was proposed by the National Medical Products Administration of the People’s Republic of China (NMPA).
This standard is under the jurisdiction of the NMPA, Center for Medical Devices Standardization Administration.
Fundamental requirements for unique
device identifier
1 Scope
This standard specifies the terms and definitions, basic principles, device identifier requirements and production identifier requirements for unique device identifier.
This standard is applicable to the management of unique device identifier.
2 Normative references
The following referenced documents are indispensable for the application 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.
GB/T 1988 Information technology — 7-bit Coded character set for information interchange
YY/T 0287 Medical devices — Quality management systems — Requirements for regulatory purposes
3 Terms and definitions
For the purposes of this standard, the terms and definitions given in YY/T 0287 and the followings apply.
3.1
unique device identifier
a series of codes consisting of numbers, letters and/or symbols created based on standards for uniquely identifying medical devices, including device identifier and production identifier
Note 1: The word "unique" does not indicate serialization management to a single product.
Note 2: It may be used for the management and traceability of medical device products.
Note 3: UDI is now used internationally to indicate “unique device identifier”.
3.2
device identifier
unique code specific to a certain specification, model and packaged medical device
Note 1: The device identifier may be used as the "access key" for the information stored in the unique identifier database of medical devices, which is associated with the product information, manufacturer information and registration information of medical devices.
Note 2: UDI-DI is now used internationally to indicate “device identifier”.
3.3
production identifier
code for identifying data in the medical device production process
Note 1: According to the actual application requirements, the production identifier may include the serial number, production batch number, production date and expiration date of medical devices.
Note 2: UDI-PI is now used internationally to indicate “production identifier”.
3.4
data delimiter
characters or character sets that define specific data elements in the unique device identifier
Note: Examples of data delimiter are application identifier (AD), object identifier (OID), etc.
4 Basic principles of unique device identifier
Basic principles of unique device identifier are:
a) The characters used shall conform to GB/T 1988 or relevant international standards;
Note: An example of such relevant international standards is ISO/IEC 646.
b) The unique device identifier shall be unique at the level of specifications, models, batches or individual products of medical devices. For medical devices with same characteristics, the uniqueness of the unique device identifier shall refer to a single specification and model product. For medical devices controlled by batch production, the uniqueness of the unique device identifier shall refer to the same batch of products. For medical devices controlled by serial number production, the uniqueness of the unique device identifier shall refer to a single product. This may be achieved by complying with international standards, such as ISO/IEC 15459-4 and ISO/IEC 15459-6, or by other appropriate means;
c) According to the specific using conditions, there shall be a corresponding verification mechanism, which is obtained by the standard algorithm, to verify the correctness of the whole or component of the unique device identifier;
d) The unique device identifier shall be as short as possible;
e) Data delimiter shall be included to ensure that all components of device identifier and production identifier can be correctly read and interpreted.
See Annex A for the structural schematic diagram of the unique device identifier.
5 Device identifier requirements
Specific requirements for device identifier are as follows:
a) It shall be able to identify the information of medical device manufacturers and the devices;
b) It shall be unique on all levels of device packaging (see Annex B).
6 Production identifier requirements
Production identification shall be used in combination with device identification, and its composition shall be determined according to device identification requirements;
a) If the medical device batch needs to be identified, the production batch number shall be included;
b) If the individual products of medical devices need to be identified, the serial number shall be included;
c) if the production date of medical devices needs to be identified, the production date shall be included;
d) If the expiration date of medical devices needs to be identified, the expiration date shall be included.
Contents of YY/T 1630-2018
Foreword i
1 Scope
2 Normative references
3 Terms and definitions
4 Basic principles of unique device identifier
5 Device identifier requirements
6 Production identifier requirements
Annex A (Informative) Structural schematic diagram of the unique device identifier
Annex B (Informative) Packaging schematic of device identifier and medical device
Bibliography
