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YY/T 1725-2020: Multiplex nucleic acid detection kit for infection of microorganisms
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| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY/T 1725-2020 | English | 189 |
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Multiplex nucleic acid detection kit for infection of microorganisms
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YY/T 1725-2020
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Basic data | Standard ID | YY/T 1725-2020 (YY/T1725-2020) | | Description (Translated English) | Multiplex nucleic acid detection kit for infection of microorganisms | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C30 | | Classification of International Standard | 11.040.30 | | Word Count Estimation | 10,186 | | Date of Issue | 2020-06-30 | | Date of Implementation | 2021-12-01 | | Issuing agency(ies) | State Drug Administration | YY/T 1725-2020: Multiplex nucleic acid detection kit for infection of microorganisms---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
Multiplex nucleic acid detection kit for infection of microorganisms
ICS 11.040.30
C30
People's Republic of China Pharmaceutical Industry Standard
Bacterial and fungal infection multiple nucleic acid detection kit
2020-06-30 released
2021-12-01 implementation
Issued by the State Drug Administration
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
Please note that certain contents of this document may involve patents. Publication of this document
The agency is not responsible for identifying these patents.
This standard was proposed by the State Drug Administration.
This standard is under the jurisdiction of the National Medical Clinical Laboratory and In Vitro Diagnostic System Standardization Technical Committee (SAC/TC136).
Drafting organizations of this standard. China Institute for Food and Drug Control, Boao Biological Group Co., Ltd., Beijing Institute of Medical Device Inspection, Tianjin
Huada Medical Laboratory Co., Ltd., Hunan Shengxiang Biotechnology Co., Ltd., Mérieux Diagnostic Products (Shanghai) Co., Ltd., Saipei (Shanghai)
Trading Co., Ltd., Guangzhou Wanfu Biotechnology Co., Ltd., Shanghai Fosun Long March Medical Science Co., Ltd., Luminex Trading (Part 1
Sea) Co., Ltd.
The main drafters of this standard. Liu Donglai, Zhang Chuntao, Zhou Haiwei, Shi Dawei, Shen Shu, Tian Yabin, Zhang Yan, Dai Leiying, Gong Yanping, Deng Zhongping,
Ma Lingli, Li Chaorui, Cai Lei, Xia Yi, Su Hongbo.
Bacterial and fungal infection multiple nucleic acid detection kit
1 Scope
This standard specifies the terms, definitions, requirements, and tests of multiple nucleic acid detection kits for bacterial and fungal infections (hereinafter referred to as "kits")
Methods, labels and instructions for use, packaging, transportation and storage, etc.
This standard applies to human samples (including blood, cerebrospinal fluid, feces, etc.) or their cultures for a single test, which can report 3 types and more.
Quality control of kits for bacteria and fungi (hereinafter referred to as "pathogenic bacteria", excluding mycoplasma and chlamydia). Suitable for detection principles
Kits for polymerase chain reaction isothermal amplification and second-generation sequencing technologies.
This standard does not apply to kits that can report 1 or 2 pathogens in a single test. Not applicable to a single test can report 1 or
Kits for different genes of two pathogens. Not applicable to a single test that can report different types of 1 or 2 pathogens (genotype or
Serotype) kit.
2 Normative references
The following documents are indispensable for the application of this document. For dated reference documents, only the dated version applies to this article
Pieces. For undated references, the latest version (including all amendments) applies to this document.
GB/T 191 Packaging, storage and transportation pictorial signs
GB/T 29791.2 Information provided by manufacturers of in vitro diagnostic medical devices (labeling) Part 2.Professional in vitro diagnostic reagents
3 Terms and definitions
The following terms and definitions apply to this document.
3.1
Nucleic acid
A class of biological macromolecules connected by nucleotides or deoxynucleotides through 3',5'-phosphodiester bonds.
Note. It has very important biological functions, mainly storing genetic information and transmitting genetic information. Includes ribonucleic acid (RNA) and deoxyribonucleic acid
(DNA) Two types.
4 requirements
4.1 Appearance
The appearance should meet but not limited to the following requirements.
a) Each component of the kit should be complete and complete, with no liquid leakage;
b) Chinese packaging labels should be clear and free from wear.
4.2 Nucleic acid extraction function
The nucleic acid extraction function should meet the following requirements.
a) For kits containing nucleic acid extraction components, the manufacturer shall make appropriate requirements for nucleic acid extraction and verify the nucleic acid extraction function;
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