GB/T 37868-2019Technical specification for traceability of nucleic acid test kit (English PDF)
核酸检测试剂盒溯源性技术规范
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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 37868-2019 is the English-translated version of 核酸检测试剂盒溯源性技术规范.
GB/T 37868-2019 is the Chinese standard "Technical specification for traceability of nucleic acid test kit". Its scope clause reads: 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. Its clauses include terms and definitions.
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Document preview — GB/T 37868-2019
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
- Introduction
- 1 Scope
- 2 Normative references
- 3 Terms and Definitions
- 4 traceability technical requirements
- 4.1 General
- 4.2 Specific requirements
- 5 traceability establishment
- 5.1 General
- 5.2 Establishment of traceability
- 5.3 Traceability Level Figure
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
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.
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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.
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