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GB/T 37868-2019 PDF English

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GB/T 37868-2019: Technical specification for traceability of nucleic acid test kit
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Standard IDUSDBUY PDFDeliveryStandard Title (Description)Status
GB/T 37868-2019199 Add to Cart 3 days Technical specification for traceability of nucleic acid test kit Valid

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GB/T 37868-2019: Technical specification for traceability of nucleic acid test kit

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(Nucleic acid detection kit traceability technical specification) ICS 07.080 G00 National Standards of People's Republic of China Nucleic acid detection kit traceability technical specification Technicalspecificationfortraceabilityofnucleicacidtestkit Published on.2019-08-30 2019-08-30 implementation State market supervision and administration China National Standardization Administration issued Content Foreword I Introduction II 1 Scope 1 2 Normative references 1 3 Terms and Definitions 1 4 traceability technical requirements 2 4.1 General 2 4.2 Specific requirements 2 5 traceability establishment 3 5.1 General 3 5.2 Establishment of traceability 3 5.3 Traceability Level Figure 4

Foreword

This standard was drafted in accordance with the rules given in GB/T 1.1-2009. This standard is proposed and managed by the National Standards Research Center. This standard was drafted. China Institute of Metrology. The main drafters of this standard. Gao Yunhua, Wang Jing, Niu Chunyan, Dong Lianhua, Fu Boqiang.

introduction

Nucleic acid detection kits are used in polymerase chain reaction (PCR, Polymerase Chain Reaction), molecular hybridization, and sequencing. Techniques such as column determination, using nucleic acid as a target for detection, widely used in forensic DNA identification, genetically modified nucleic acid testing, viruses and bacteria Such as pathogenic microbial nucleic acid testing, genetic diseases and tumor gene detection and other fields. This standard specifies the traceability of the nominal characteristic values and magnitudes of reagent components in nucleic acid detection kits. Nucleic acid detection kit traceability technical specification

1 Scope

This standard specifies the terms and definitions, technical requirements, and traceability of the traceability of nucleic acid detection kits. This standard applies to the traceability of the nominal characteristic values and magnitudes of reagent components indicated in the nucleic acid detection kit during research and development, production and application. Sexual establishment.

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. JJF1001-2011 General Measurement Terms and Definitions JJF1265-2010 Biometric Terms and Definitions

3 Terms and definitions

The terms and definitions defined by JJF1001-2011 and JJF1265-2010 apply to this document. For ease of use, the following repeating columns Some terms and definitions in JJF1001-2011 and JJF1265-2010 are presented. 3.1 Tracing traceability The value of the measurement result or measurement standard can be compared with the specified reference mark through an uninterrupted comparison chain with a specified uncertainty Standard, usually a characteristic associated with national or international measurement standards. Note 1. This concept is often used to describe the adjective “traceable”. Note 2. This uninterrupted comparison chain is called the traceability chain. [JJF1265-2010, Definition 3.3] 3.2 Nominal property nominalproperty A phenomenon, an object, or a substance that is not distinguished by size. Example 1. The gender of a person. Example 2. Color of the paint sample. Example 3. Color of spot test in chemistry. Example 4. ISO two-letter country code. Example 5. Sequence of amino acids in a polypeptide. Note 1. The nominal characteristic has a value, which can be represented by text, letter code or other means. Note 2. “Nominal characteristic value” should not be confused with “quantity value”. [JJF1001-2011, definition 3.32] 3.3 Quantitative value The value of the full weighing (valueofaquantity), referred to as the value (value). The size of the quantity represented by the number and the reference object. GB/T 37868-2019 (Nucleic acid detection kit traceability technical specification) ICS 07.080 G00 National Standards of People's Republic of China Nucleic acid detection kit traceability technical specification Technicalspecificationfortraceabilityofnucleicacidtestkit Published on.2019-08-30 2019-08-30 implementation State market supervision and administration China National Standardization Administration issued Content Foreword I Introduction II 1 Scope 1 2 Normative references 1 3 Terms and Definitions 1 4 traceability technical requirements 2 4.1 General 2 4.2 Specific requirements 2 5 traceability establishment 3 5.1 General 3 5.2 Establishment of traceability 3 5.3 Traceability Level Figure 4

Foreword

This standard was drafted in accordance with the rules given in GB/T 1.1-2009. This standard is proposed and managed by the National Standards Research Center. This standard was drafted. China Institute of Metrology. The main drafters of this standard. Gao Yunhua, Wang Jing, Niu Chunyan, Dong Lianhua, Fu Boqiang.

introduction

Nucleic acid detection kits are used in polymerase chain reaction (PCR, Polymerase Chain Reaction), molecular hybridization, and sequencing. Techniques such as column determination, using nucleic acid as a target for detection, widely used in forensic DNA identification, genetically modified nucleic acid testing, viruses and bacteria Such as pathogenic microbial nucleic acid testing, genetic diseases and tumor gene detection and other fields. This standard specifies the traceability of the nominal characteristic values and magnitudes of reagent components in nucleic acid detection kits. Nucleic acid detection kit traceability technical specification

1 Scope

This standard specifies the terms and definitions, technical requirements, and traceability of the traceability of nucleic acid detection kits. This standard applies to the traceability of the nominal characteristic values and magnitudes of reagent components indicated in the nucleic acid detection kit during research and development, production and application. Sexual establishment.

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. JJF1001-2011 General Measurement Terms and Definitions JJF1265-2010 Biometric Terms and Definitions

3 Terms and definitions

The terms and definitions defined by JJF1001-2011 and JJF1265-2010 apply to this document. For ease of use, the following repeating columns Some terms and definitions in JJF1001-2011 and JJF1265-2010 are presented. 3.1 Tracing traceability The value of the measurement result or measurement standard can be compared with the specified reference mark through an uninterrupted comparison chain with a specified uncertainty Standard, usually a characteristic associated with national or international measurement standards. Note 1. This concept is often used to describe the adjective “traceable”. Note 2. This uninterrupted comparison chain is called the traceability chain. [JJF1265-2010, Definition 3.3] 3.2 Nominal property nominalproperty A phenomenon, an object, or a substance that is not distinguished by size. Example 1. The gender of a person. Example 2. Color of the paint sample. Example 3. Color of spot test in chemistry. Example 4. ISO two-letter country code. Example 5. Sequence of amino acids in a polypeptide. Note 1. The nominal characteristic has a value, which can be represented by text, letter code or other means. Note 2. “Nominal characteristic value” should not be confused with “quantity value”. [JJF1001-2011, definition 3.32] 3.3 Quantitative value The value of the full weighing (valueofaquantity), referred to as the value (value). The size of the quantity represented by the number and the reference object. ......

Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.

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