GB/T 37875-2019Technical specification for quality evaluation of nucleic acid extraction and purification kits (English PDF)
核酸提取纯化试剂盒质量评价技术规范
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Issued by
SAMR; SAC
Level / Type
National · Recommended
Issue date
August 30, 2019
Implementation date
August 30, 2019
Scope
GB/T 37875-2019 is the English-translated version of 核酸提取纯化试剂盒质量评价技术规范.
GB/T 37875-2019 is the Chinese standard "Technical specification for quality evaluation of nucleic acid extraction and purification kits".
Its scope clause reads: This standard specifies the terms and definitions of quality evaluation of nucleic acid extraction and purification kits, technical indicators for quality evaluation and evaluation methods.
This standard applies to the production and service of DNA and RNA extraction and purification kits for bacteria, plasmids, eukaryotic cells, etc. Its clauses include terms and definitions, abbreviations.
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Document preview — GB/T 37875-2019
National Standard of the People's Republic of China
- ICS
- 07.080
- Classification
- G 00
Issued by: State Administration for Market Regulation; Standardization Administration of the PRC
Contents
- Foreword
- 1 Scope
- 2 Normative references
- 3 Terms and definitions, abbreviations
- 3.1 Terms and Definitions
- 3.2 Abbreviations
- 4 Evaluation Indicator
- 4.1 Production
- 4.2 Purity
- 4.3 Completeness
- 4.4 Repeatability
- 4.5 Reproducibility
- 4.6 Inter-batch variation
- 4.7 Bacterial endotoxin residues
- 5 Evaluation method
- 5.1 General
- 5.2 Production
- 5.3 Purity
- 5.4 Integrity
- 5.5 Repeatability
- 5.6 Reproducibility
- 5.7 Inter-batch differences
- 5.8 Bacterial endotoxin residues
- 6 Quality Evaluation Report
1 Scope
This standard specifies the terms and definitions of quality evaluation of nucleic acid extraction and purification kits, technical indicators for quality evaluation and evaluation methods.
This standard applies to the production and service of DNA and RNA extraction and purification kits for bacteria, plasmids, eukaryotic cells, etc.
2 Normative references
The following documents are indispensable for the application of this document. For dated references, only dated versions apply to this article.
Pieces. For undated references, the latest edition (including all amendments) applies to this document.
GB/T 20001.4-2015 Standard Writing Rules Part 4. Test Method Standards
JJF1001-2011 General Measurement Terms and Definitions
JJF1265-2010 Biometric Terms and Definitions
3 terms and definitions, abbreviations
3.1 Terms and definitions
The following terms and definitions defined in GB/T 20001.4-2015, JJF1001-2011 and JJF1265-2010 apply to this paper.
Pieces. For ease of use, the following lists one of GB/T 20001.4-2015, JJF1001-2011 and JJF1265-2010.
These terms and definitions.
3.1.1 Nucleic acid primary structure
The order of nucleotides (or base order) in a polynucleotide chain.
3.1.2 Reference material
A substance with a sufficiently uniform and stable specific characteristic whose characteristics have been proven to be suitable for use in measurement or in the investigation of nominal characteristics use.
[JJF1001-2011, definition 8.14]
3.1.3 Precision
The degree of agreement between the independent test/measurement results obtained under specified conditions.
Note 1. Precision depends only on the distribution of random errors, independent of true or specified values.
Note 2. The measure of precision is usually expressed in terms of “not precise”, and its value is expressed by the standard deviation of the test result or measurement result. Standard deviation
Large, the lower the precision.
Note 3. The quantitative measure of precision is strictly dependent on the specified conditions, and the repetitive conditions and reproducibility conditions are two extreme cases.
[GB/T 20001.4-2015, definition 3.3] […]
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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 15 pages — is available in the English PDF.
Referenced standards
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