JJF 1718-2018The Production of Genetically Modified Plant Nucleic Acid Reference Materials (English PDF)
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Issued by
State Administration for Market Regulation
Level / Type
National · Mandatory
Issue date
June 25, 2018
Implementation date
September 25, 2018
Scope
JJF 1718-2018 (The Production of Genetically Modified Plant Nucleic Acid Reference Materials) is available as an English-translated PDF.
JJF 1718-2018 — This standard specifies the requirements for the development planning, preparation, homogeneity assessment, stability assessment, interchangeability assessment, valuation, uncertainty assessment, development report and certificate, packaging and preservation of genetically modified plant nucleic acid reference materials, and is applicable to the guidance of genetic modification.
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Document preview — JJF 1718-2018
National Standard of the People's Republic of China
- ICS
- 17.020
- Classification
- A 50
Issued by: State Administration for Market Regulation
Contents
- Introduction (II)
- 1 Scope (1)
- 2 References (1)
- 3 Terms and definitions (1)
- 4 General principles (2)
- 5 Development Planning (3)
- 6 Preparation (3)
- 6.1 Candidate Requirements (3)
- 6.2 Preparation and Packaging (3)
- 7 Uniformity assessment (3)
- 8 Stability Assessment (4)
- 9 Interchangeability assessment (4)
- 9.1 Evaluation Principles (4)
- 9.2 Evaluation plan (4)
- 10 Fixed value (4)
- 10.1 Determination of the reference substance of the transgenic plant matrix (4)
- 10.2 Determination of genetically modified plasmid reference materials and genetically modified plant genome standards (5)
- 10.3 Quality Control (5)
- 10.4 Data Evaluation (5)
- 10.5 Fixed value results and uncertainty of reference materials (5)
- 11 Development Report and Certificate (5)
- 11.1 Development Report (5)
- 11.2 Certificates and Labels (6)
- 12 Save (6)
- Appendix A Example of Interchangeability Evaluation of Genetically Modified Maize NK603 Plasmid Standard Material (GB W10086) (7)
1 Scope (1)
2 References (1)
3 Terms and definitions (1)
4 General principles (2)
5 Development Planning (3)
6 Preparation (3)
6.1 Candidate Requirements (3)
6.2 Preparation and Packaging (3)
7 Uniformity assessment (3)
8 Stability Assessment (4)
9 Interchangeability assessment (4)
9.1 Evaluation Principles (4)
9.2 Evaluation plan (4)
10 Fixed value (4)
10.1 Determination of the reference substance of the transgenic plant matrix (4)
10.2 Determination of genetically modified plasmid reference materials and genetically modified plant genome standards (5)
10.3 Quality Control (5)
10.4 Data Evaluation (5)
10.5 Fixed value results and uncertainty of reference materials (5)
11 Development Report and Certificate (5)
11.1 Development Report (5)
11.2 Certificates and Labels (6)
12 Save (6)
Appendix A Example of Interchangeability Evaluation of Genetically Modified Maize NK603 Plasmid Standard Material (GB W10086) (7)
Introduction
Transgenic plant nucleic acid reference material is used as a carrier for measuring the value traceability and transmission, and is widely used in transgenic plants.
In the testing activities of its products, the quality of reference materials ensures the effectiveness of the above activities and solves the transgenic plants.
The consistency of the test results of its products is of great significance. The purpose of this specification is to regulate the genetic material of genetically modified plants.
The development process provides standard substances that meet the quality requirements for activities such as the detection of genetically modified plants and their products.
This specification is JJF 1342 "General Requirements for Standard Substance Development (Production) Organizations" and JJF 1343 "Standard Substances" the general principle of valuation and the principle of statistics are the guiding principles, refer to GB/T 3543.5 "Crop seed test the contents of technical documents such as the authenticity of the procedure and the identification of the purity of the variety.
This specification is the first release.
Development of nucleic acid reference materials for transgenic plants
1 Scope
This specification specifies the development planning, preparation, uniformity evaluation and stability evaluation of genetically modified plant nucleic acid reference materials.
Requirements for assessment, interchangeability assessment, valuation, uncertainty assessment, development reports and certificates, packaging and storage, etc.
Guide the development of nucleic acid reference materials for transgenic plants.
2 reference files
This specification refers to the following documents.
JJF 1006 Primary Standard Material Technical Specification JJF 1059.1 Measurement Uncertainty Evaluation and Representation JJF 1186 Standard Substance Certification Certificate and Label Content Writing Rules JJF 1218 Standard Substance Development Report Writing Rules JJF 1265 Biometric Terms and Definitions JJF 1342 Standard material development (production) organization general requirements General Principles and Statistical Principles of JJF 1343 Standard Substances GB/T 3543.5 Authenticity and variety purity identification of crop seed test procedures GB 8170 Numerical Rounding Rules and Representation and Determination of Limit Values General requirements for the detection of NY/T 672 transgenic plants and their products NY/T 1101 Guidelines for the Evaluation of Edible Safety of Genetically Modified Plants and Their Products Regulations on the Safety Management of Agricultural Genetically Modified Organisms (Order No. 304 of the State Council of the People's Republic of China) National Science and Technology Terminology Committee. Genetic term for dated references, only dated versions apply to this specification; undated quotations the latest version (including all amendments) applies to this specification.
3 Terms and definitions 3.1 genetically modified plant geneticymodifiedplant Genetically engineered plants that alter the genome.
[NY/T 672, 3.1.2]
3.2 Receptor plant recipientplant Refers to a plant into which a recombinant DNA molecule has been introduced.
[NY/T 1101, 2.3]
3.3 transgenic plant nucleic acid standard substance geneticymodifiedplantnucleicacidreferencematerial Has sufficient uniformity and stability for calibration, validation and quality of nucleic acid component measurement procedures in transgenic plants a substance that is controlled.
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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 11 pages — is available in the English PDF.
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