GB/T 29889-2013DNA microarray for disease susceptibility DNA polymorphisms (English PDF)
人体疾病易感DNA多态性检测基因芯片
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Issued by
SAMR; SAC
Level / Type
National · Recommended
Issue date
November 12, 2013
Implementation date
April 11, 2014
Scope
GB/T 29889-2013 is the English-translated version of 人体疾病易感DNA多态性检测基因芯片.
GB/T 29889-2013 is the Chinese standard "DNA microarray for disease susceptibility DNA polymorphisms".
Its scope clause reads: This standard specifies the relevant terms and definitions used in human disease susceptibility gene DNA polymorphism detection chip packages, and human disease Test sample DNA polymorphism detection disease susceptibility gene chips, testing sites, chip requirements, evaluation model, evaluation reports, testing service Service requirements for approval.
This standard applies to human disease susceptibility gene DNA polymorphism detection chip products. Its clauses include terms and definitions; abbreviations; test sample.
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Document preview — GB/T 29889-2013
National Standard of the People's Republic of China
- ICS
- 11.040.55
- Classification
- C 30
Issued by: State Administration for Market Regulation; Standardization Administration of the PRC
Contents
- 1 Scope
- 2 Normative references
- 3 Terms and Definitions
- 4 Abbreviations
- 5 test sample
1 Scope
This standard specifies the relevant terms and definitions used in human disease susceptibility gene DNA polymorphism detection chip packages, and human disease
Test sample DNA polymorphism detection disease susceptibility gene chips, testing sites, chip requirements, evaluation model, evaluation reports, testing service
Service requirements for approval.
This standard applies to human disease susceptibility gene DNA polymorphism detection chip products.
2 Normative references
The following documents for the application of this document is essential. For dated references, only the dated version suitable for use herein
Member. For undated references, the latest edition (including any amendments) applies to this document.
GB/T 27990 biochip basic terms
ISO 15189 requirements for quality and competence of medical laboratories (Medicallaboratories-Particularrequirements forqualityandcompetence)
ISO /IEC 17025 General requirements for testing and calibration laboratories (Generalrequirementforthecompetenceof testandcalibrationlab)
3 Terms and Definitions
GB/T 27990 and defined by the following terms and definitions apply to this document.
3.1 Disease susceptibility DNA polymorphism diseasesusceptibilityDNApolymorphisms
In order to carry out research projects and have selected certain features of the crowd, and the occurrence and development of diseases associated with DNA more clearly
Normality.
4 Abbreviations
The following abbreviations apply to this document.
CAP. College of American Pathologists (ColegeofAmericanPathologists)
CLIA. Clinical Laboratory Improvement Act (ClinicalLaboratoryImprovementAmendments)
5 test sample
5.1 types of samples
Kind of test samples may include. blood, saliva, oral mucosa, tissue.
Samples collected 5.2
Establish standard sampling procedures for each sample to be tested collection provisions in the specified place in accordance with the formal process of collection to meet the standard sampling
Sample quality requirements.
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 15 pages — is available in the English PDF.
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