GB/T 19626-2005 General technical requirements for DNA anti-counterfeiting technology products
other information
Release date:2005-01-13
drafter:Wang Xiaoping, Gao Lisheng, Zhao Gang, Zeng Yi, Xu Junjie, Liang Minghua, Zhan Chunsheng, Xu Junlong
Drafting unit:Ministry of Public Security Anti-counterfeiting Product Quality Supervision and Inspection Center, Lubo Biotechnology (Suzhou) Co., Ltd.
Focal point unit:National Anti-Counterfeiting Standardization Technical Committee (SAC/TC 218)
Proposing unit:General Administration of Quality Supervision, Inspection and Quarantine
Publishing department:General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China Standardization Administration of China
competent authority:National Standardization Administration
Some standard content:
ICS 13.310
National Standard of the People's Republic of China
CB/T196262005
General technical requirements of DNA Anti-counterfeit lechnical products2005-01-13 Issued
General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China Standardization Administration of China
2005-06-01 Implementation
GB/T19626—2005
This standard describes the anti-counterfeiting characteristics of DNA anti-counterfeiting products. Other characteristics have relevant national standards and testing methods. This standard was proposed by the General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China and approved by the General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China and the Standardization Administration of the People's Republic of China. This standard is interpreted by the National Technical Committee for Anti-counterfeiting Standardization (SAC/TC218). Drafting units: Anti-counterfeiting Product Quality Supervision and Inspection Center of the Ministry of Public Security, Lubo Biotechnology (Zhou) Co., Ltd. The main drafters of this standard: Wang Xiaoping, Shang Lisheng, Zhao Gang, Zeng Yi, Xu Junjie, Liang Minghua, Zhan Chunsheng, Xu Junlong, this standard is released for the first time,
1 Scope
General technical requirements for DNA anti-counterfeiting technology products
GE/T19626--2005
This standard specifies the general technical requirements for DNA anti-counterfeiting technology products, relevant terms, definitions, abbreviations and unit symbols, product classification, technical requirements, testing, evaluation methods, acceptance rules, labeling, packaging, transportation and storage. This standard applies to all kinds of DNA anti-counterfeiting technology products. 2 Normative references
The clauses in the following documents become the clauses recommended by this standard through reference in this standard. For all dated references, all subsequent amendments (excluding errata) or revisions are not applicable to this standard. However, all parties who reach an agreement based on this standard are encouraged to study whether the latest versions of these documents can be used. For all undated references, the latest versions apply to this standard. GB15193.3-2003 Acute toxicity test
GB15193.12-2003 In vitro mammalian cell (V7)/H (PRT) gene mutation test GB/119425-2003 General technical conditions for anti-counterfeiting technology products GA/T383-2002 Forensic science IDNA laboratory inspection specifications 3 Terms, definitions, abbreviations and unit symbols The following terms, definitions, abbreviations and unit symbols apply to this standard. 3. 1
Deoxyribonucleobase deoxyribonucleobase DNA, is the abbreviation of deoxyribonucleobase, is the transfer material that stores biological genetic information. 3.2
Genome
refers to all the DNA in the cells of a species.
Gene
refers to a specific base fragment.
Sequence
refers to a fixed sequence DAA fragment.
Polymerase chain reaction (PCR) is a fast and economical technology to copy countless DNA fragments. 3.6
Acute toxicity
refers to the toxic effects that occur in the short term after the body (human or experimental animal) is exposed to exogenous chemicals once or multiple times within 24 hours, including the death effect.
Genetic toxicity
Due to the interaction between chemicals and other environmental factors and toxicity, the specific changes in the molecular structure of the gene in the cells of the animal are caused. This harmful action leads to genetic toxicity.
GB/T 19626—2005
Infectious
The property of being contagious and causing disease.
Primer
Primer is a short segment of TNA that interacts with the amplified template TVA sequence and can bind to the denatured NA to provide a starting position for the polymerase to synthesize a new VA molecule chain, that is, a short INA sequence segment used in polymerase chain reaction. 3.10
Basematerial
Basematerial is a carrier used to mix with IA, such as oil, plastic, paint, paper, etc. 3. 11
Testing sample
refers to the product of nanoDNA Lu Che technology.
Standard sample
refers to the standard of known DNA
DNA sequence uniguensesLNA anti-counterfeiting technology product DAA Uniqueness is based on the uniqueness of the DNA sequence. The identity of the anti-counterfeiting technology product is constructed by selecting and combining different DXA sequences (including the innovation of anti-counterfeiting measures). 3.14 Stability refers to the degree to which the base pair arrangement in the DNA remains intact and the structure is not broken or damaged under various test environments. 3.15 Base pair (bp) A pair of bases that form a horizontal bar in the shape of DNA. A nucleotide is composed of one molecule of carbon, one molecule of phosphate and one molecule of nitrogenous base. The base is the "mother" of the DNA code. In DNA, the code letters are A, T and C, which represent the chemical substances adenine, thymine, guanine and cytosine respectively. In the base pair, adenine always pairs with thymine, guanine always pairs with cytosine, and DNA always pairs with cytosine. DNA anti-counterfeit technical products are anti-counterfeit technical products made using the unique 1DNA genetic code of animals: 4 Product classification
DNA anti-counterfeit technical products can be divided into a large category according to the logo, material and others. 4. 1DNA anti-counterfeiting logo
DNA logo made by printing or coating technology, including: A) TDNA label;
b) DVA ticket;
()DNA securities;
d) other DNA printed products.
4.2I3DNA anti-counterfeiting materials
Anti-counterfeiting materials made by mixing eight and different materials, 4. 2. 1E)DNA anti-counterfeiting safety paper
Paper with DNA anti-counterfeiting function used for printing securities and certificates. 4.2.2 DNA anti-counterfeiting holographic film
Anti-counterfeiting material made by combining DA with anti-counterfeiting holographic film. 4.2.3 DNA anti-counterfeiting ink
Anti-counterfeiting material made by combining A with printing oil. 4.2.4 DNA anti-counterfeiting printing ink
a) DNA ultraviolet excitation fluorescence anti-counterfeiting diagnostic printing ink; b) DNA other printing ink
4.2.5 DNA special material anti-counterfeiting technology products are products or packaging made by combining non-transferable or difficult-to-copy materials with NA. 4.3 Other DNA anti-counterfeiting technology products
refers to DNA anti-counterfeiting technology products other than the above-mentioned logos and materials. 5 Technical requirements
5.1 Anti-counterfeiting strength of DNA anti-counterfeiting technology products GB/T 19626—2005
The anti-counterfeiting strength value of DNA anti-counterfeiting technology products should be greater than 60. The anti-counterfeiting strength value is composed of four factors: the number of anti-counterfeiting technologies implemented, the number of anti-counterfeiting technology exclusivities, the difficulty of deciphering, and the cost of imitation. The conditions that each factor should meet and the anti-counterfeiting strength values of each level should comply with the provisions of Table 1.
Table 1 Components of anti-counterfeiting strength value, conditions that should be met, and anti-counterfeiting strength values
Components
The obtained DNA
Does not belong to the sequence
Type of DXA
Imitation difficulty
Imitation difficulty
Types of wood
Exceeding
Urap--he
Seeds and above
The comprehensive judgment of anti-counterfeiting strength is accumulated according to items 1-4 of Table 1, and is divided into: Grade A 97-~103
90-~96
75-~89
D level 60~74
5.2 Anti-counterfeiting technology products should have unique identityC level
lt\bp~-19'hp
More than 5 types
.l0\hp
More than 3 types
D:A anti-counterfeiting technology products should have identity uniqueness not lower than level D. The inspection items and grading indicators of identity uniqueness are shown in Table 2. The higher the grading indicator, the better the identity chain. IN: A anti-counterfeiting technology products should meet the identity uniqueness requirements in Table 2. GB/T19626--2005
Product category
DNA anti-counterfeiting carbon identification
DNA anti-counterfeiting materials
Table 2 Requirements for uniqueness of identity of DNA anti-counterfeiting technology products Inspection items
Sequence non-transmittance/%
Ratio of damage immediately after opening
INA Biological characteristic sequence
DNA identification means
Number of using enterprises/unit
Information uniqueness?Listen
5.3 Stability period of anti-counterfeiting characteristics of DNA anti-counterfeiting technology products 100
Grading index
The anti-counterfeiting identification characteristics of DNA anti-counterfeiting technology products should have a stability period of not less than Grade T). The specific requirements are shown in Table 3. Table 3 Requirements for the stability period of anti-counterfeiting characteristics of DNA anti-counterfeiting technology products Category DNA anti-counterfeiting label Anti-counterfeiting mouse Anti-counterfeiting ink and printing oil NA biometric sequence DNA identification means 5.4 Recognition performance of DNA anti-counterfeiting technology products Requirements for the stability period of anti-counterfeiting performance (months, not less than) Class B Anti-counterfeiting technology products should have an identification performance not lower than Class D. When the anti-counterfeiting technology products are inspected by appearance, simple tools or special instruments, the specific requirements for the genuine pass rate, fake pass rate, authenticity uncertainty rate and judgment time are shown in Table 4. Table 4 Identification performance requirements for DNA anti-counterfeiting technology products Order
Authentic product selection rate/
Fake product selection rate/%
Uncertainty between authenticity and fakeness/%
Prohibition time
5. 5 DNA anti-counterfeiting technology product use adaptability Class AbZxz.net
Identification performance requirements
Specified in product standards
DNA anti-counterfeiting technology product use adaptability should be able to meet the requirements of various products or subject matter. Specific requirements shall be implemented in accordance with GB/T191252303 General technical conditions for anti-counterfeiting technology products 5. 6 DNA anti-counterfeiting technology product use environment requirements The anti-counterfeiting performance of DNA anti-counterfeiting technology products should be able to meet the requirements of the subject matter: normal use environment. Specific requirements shall be implemented in accordance with the relevant provisions of (GB/119.125--2003 "General Technical Conditions for Anti-Counterfeiting Technology Products". 5.7 Technical security and confidentiality of DNA anti-counterfeiting technology products GB/T 19626-2005
DNA anti-counterfeiting technology products have strict security and confidentiality measures in the process of research, production and transportation. Specific requirements shall be implemented in accordance with the relevant regulations of GB/I19425-2003 "General Technical Conditions for Anti-Counterfeiting Technology Products". 5.8 Safe use period of DNA anti-counterfeiting technology products. Manufacturers should promise the safe use period of D>A anti-counterfeiting technology products. The specific requirements for the safe use period are shown in Table 5. Table 5 Safe use period of DNA products promised by manufacturers (pieces, not less than) Class A
5. 9 DNA contained in DNA anti-counterfeiting technology products Testing requirements Class C
DNA in DNA anti-counterfeiting technology products should be able to meet the following DNA testing requirements. 5.9.1 DNA amplification test
DNA After amplification, the length of each fragment of the sample to be tested is consistent with the provided standard product. 5.9.2 DNA typing test
DNA After typing phase separation, the sample to be tested is consistent with the provided standard product type. 5.9.3 DNA sequencing test
DNA After sequence analysis, the sample to be tested is consistent with the provided standard product sequence: 5.10 DNA safety requirements for DNA contained in DNA anti-counterfeiting technology products The safety of DNA in DNA anti-counterfeiting technology products should be consistent with the relevant national DNA safety regulations. 5.0.1 Biological genetic toxicity requirements
The DNA in DNA anti-counterfeiting technology products has biological genetic toxicity, 5. 10.2 Biological acute toxicity requirements
DNA in DNA anti-counterfeiting technology products does not have biological acute toxicity. 5.10.3 Infectivity requirements
DNA in DNA anti-counterfeiting technology products does not have infectious properties. 5.10.4 Concentration requirements
DNA concentration in DNA anti-counterfeiting technology products must meet the requirements: when DNA is mixed with matrix, the ratio of NA to matrix should be less than 1/10,000.
5.10.5 Environmental requirements
DNA anti-counterfeiting technology products must pass environmental testing requirements. 6 Test, verification and evaluation methods
6.1 Method for checking anti-counterfeiting strength
The anti-counterfeiting strength of DNA anti-counterfeiting technology products (see 5.1) is determined by the sum of the values obtained from the first and second inspections in Table 1. 6.1.1 The length of DNA fragment I shall be verified item by item according to the actual length of DNA in DNA anti-counterfeiting technology products. 6.1.2 The types of DNA with different sequences shall be verified according to DV.1 The actual TNA and types in the anti-counterfeiting technology products shall be verified and stored item by item. 6.1.3 Method for determining the difficulty of DNA anti-counterfeiting technology imitation The difficulty of DNA anti-counterfeiting technology imitation shall be determined by evaluating the number of disciplines involved in DNA anti-counterfeiting technology, the professional level of researchers, the advanced level of technical equipment and means required for the manufacture, the impact of public sources on reducing the difficulty of manufacture and the ease of replication.
6.t.4: Method for determining the cost of imitation
The cost of imitation shall be determined by 5 registered anti-counterfeiting experts based on the cost of manufacturing equipment and site, labor and material costs. 6.2 Method for checking uniqueness (see 5.2) The identity of TNA anti-counterfeiting technology products shall be checked by the following method: GB/T 19626-2005
6.2.1 The sequence of LNA anti-counterfeiting mark shall not be renatured and shall be checked by sequence comparison. During the inspection, the probability of sequence non-repetition shall comply with the provisions of Table 2.
6.2.2 The identity uniqueness of DNA anti-counterfeiting materials shall be checked manually. When the normal anti-counterfeiting materials are opened during the inspection, their anti-counterfeiting structure shall be damaged and their anti-counterfeiting function shall be lost and cannot be restored: 6.2.3 The number of enterprises using the DNA biometric sequence shall be verified and checked according to the number of enterprises using it. 6.2.4 The uniqueness of the DNA identification method must be unique and non-repetitive, complying with the provisions of Table 2. 6.3 Inspection method for the stability period
The stability period of the anti-counterfeiting characteristics of DNA anti-counterfeiting technology products (see 5.3) shall be checked according to the relevant provisions of GB/T19125-2003 General Technical Conditions for Anti-Counterfeiting Technology Products.
6.4 Inspection method for identification performance
The identification performance (see 5.4) is inspected by the following method. When 10,000 test samples mixed with 1,000 counterfeit products are identified by simple appearance tools or special instruments, the pass rate of genuine products, the miss rate of counterfeit products, and the uncertainty rate of authenticity should meet the requirements of Table 4, and the judgment time should meet the requirements of the standard for counterfeit technology products. 6.5 Inspection method for use adaptability
The use adaptability of DNA anti-counterfeiting technology products (see 5.5) shall be inspected in accordance with the relevant provisions of GB3/T19425-2003 General Technical Conditions for Anti-Counterfeiting Technology Products.
6.6 Inspection method for use environment performance
[NA]The use environment requirements for anti-counterfeiting technology products (see 5.6) shall be inspected in accordance with the use environment test method specified for the subject matter. The specific requirements shall be in accordance with (GB/\T19425-2003 "General Technical Conditions for Anti-Counterfeiting Technology Products" 6.7 Inspection method for technical safety and confidentiality
Technical safety and confidentiality (see 5.7) is inspected by observation method, and each item is inspected according to the requirements of Article 5.7. If all requirements are met, the item is qualified.
6.8 Inspection method for safe use period
Safe use period (see 5, 8) is inspected by complaint method. If there is no user complaint from the manufacturer during the commitment period, the requirement is qualified. If the complaint is not verified, it is unqualified. 6.9 DNA testing method
6.9.1 DNA amplification test
6.9.1.1 National
Used to detect whether the DNA fragment and length in the DNA anti-counterfeiting technology product are correct. 6.9.1.2 Principle
First, design a primer pair that complements the DNA you want to amplify, and use the change in humidity to denature the primers, bind them, and extend the new DNA molecules under the action of the enzyme. Repeat the temperature change cycle to obtain a large number of replicated DNA: 6.9.1.3 Materials and Equipment
) Materials: polymerase, primers, nucleotides, magnesium ions, buffer and DNA to be tested. h) Equipment: DNA amplification instrument capillary electrophoresis instrument. 6.9.1.4 Experimental steps
Put the reaction solution (see b.9.1.3) After sufficient mixing, perform LNA amplification. The products obtained after the reaction can be separated by electrophoresis, fluorescent staining, or other appropriate methods to test whether they are the same as the standard product. 6.9.1.5 Primers
The manufacturer shall provide the required primers to the testing unit. 6.9.1.6 Control test
When the testing unit performs the anti-damage performance test of the LNA anti-counterfeiting technology product, it shall also set up a "control test" to test the function and purity of the primers.
6.9.2DNA type analysis test
6.9.2.1 Purpose
To detect whether the DNA type in the DNA anti-counterfeiting technology product is consistent and correct. 6.9.2.2 Principle
GB/T 19626--2005
First, design a primer pair complementary to the DNA to be amplified, use temperature changes to denature the primers and DNA, and bond them. Under the action of DNA synthase, the new DNA molecules are extended. Repeat the temperature change cycle to obtain a large number of replicated DNA fragments. Several fragments are synthesized into a specific DNA type.
6.9.2.3 Materials and equipment
The materials and equipment are the same as 6.9.1.3.
6.9, 2.4 Test steps
After thoroughly mixing the primer solution (see 6.9.2.3), perform 1A amplification. The products obtained after reaction can be separated by electrophoresis, fluorescent staining, or other appropriate methods to test and compare with the standard product to obtain products of different types. 6.9.2.5 Primers
The manufacturer shall provide the required primers to the testing unit. 6.9.2.6 Control test
The control test is the same as 6.5.1.6.
6.9.3 DNA sequencing test
6.9.3.1 Purpose
To detect whether the DNA sequence in the AA anti-counterfeiting technology product is consistent and correct. 6.9.3.2 Principle
Refer to GA/T 3832002 implementation
6.9.3.3 Materials and equipment
a) Materials: sequencing kit.
b) Equipment: DNA sequencing analyzer.
6. 9. 3. 4 Test steps
The test steps shall be carried out in accordance with the instructions of the sequencing reagent basin. 6.10 DNA safety test
6.10.1 Biological genetic toxicity test
Perform in accordance with GB1=193.12
6.10.2 Biological acute toxicity test
Perform in accordance with GB 15193.3.
6.10.3 Infectivity test
Perform in accordance with relevant regulations.
6.10.41) NA concentration test
6.10.4.1 Principle
The standard substance and the sample to be tested have the same dilution rate. 6.10.4.2 Materials and equipment
Materials and equipment are the same as those in 6.9.1.3.
6.10.4.3 Test steps
a) DNA contained in the test sample and the standard sample was diluted 10 times, 100 times, 1000 times and 10000 times after extraction. b) The diluted sample was tested by the test method in Article 6.9 and the results were the same. GB/T 19626--2005
6.10.5 Environmental test
6. 10.5.1 Principle
DNA anti-counterfeiting technology products can still keep the DNA sequence intact after environmental testing. 6. 10.5.2 Equipment
Ultraviolet light box, ? Lay line irradiator, constant temperature 6.10.5.3 Test steps
DNA anti-counterfeiting technology products can still pass the test in Article 6.9 after being treated according to the environmental test items in Table 6. Table 6 Environmental test items
Ultraviolet light
Acidity
Acceptance rules
Test content
5 ≤ Acceptable within 2.36 3/cm or 30 large within 260 J1/cm equivalent to 30Gy radiation energy accumulation
121℃ for 48h
-8℃ for 48h
pH 1--11 aqueous solution for 1h
According to the relevant provisions of (GB/T19425-2003 "General Technical Conditions for Anti-Counterfeiting Products", marking, packaging, transportation and recommendation
According to the relevant provisions of GB/T19425:2003 "General Technical Conditions for Anti-Counterfeiting Products".36 3/cm or 30 large internal changes to 260 J1/cm equivalent to 30Gy radiation energy accumulation
121℃ Celsius for 48h
Celsius -8℃ for 48h
pH 1--11 aqueous solution for 1h
According to the relevant provisions of (13/T19425-2003 "General Technical Conditions for Anti-Counterfeiting Products", marking, packaging, transportation and recommendation
according to the relevant provisions of GB/T19425:2003 "General Technical Conditions for Anti-Counterfeiting Products".36 3/cm or 30 large internal changes to 260 J1/cm equivalent to 30Gy radiation energy accumulation
121℃ Celsius for 48h
Celsius -8℃ for 48h
pH 1--11 aqueous solution for 1h
According to the relevant provisions of (13/T19425-2003 "General Technical Conditions for Anti-Counterfeiting Products", marking, packaging, transportation and recommendation
according to the relevant provisions of GB/T19425:2003 "General Technical Conditions for Anti-Counterfeiting Products".
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