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YY/T 1918-2023: Digital polymerase chain reaction analysis system
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| YY/T 1918-2023 | English | 219 |
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Digital polymerase chain reaction analysis system
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YY/T 1918-2023
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Basic data | Standard ID | YY/T 1918-2023 (YY/T1918-2023) | | Description (Translated English) | Digital polymerase chain reaction analysis system | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C44 | | Classification of International Standard | 11.100.10 | | Word Count Estimation | 11,111 | | Date of Issue | 2023-09-05 | | Date of Implementation | 2024-09-15 | | Issuing agency(ies) | State Drug Administration | | Summary | This standard specifies the classification, requirements, test methods, labels, identification and instructions for use, packaging, transportation and storage of digital polymerase chain reaction analysis systems. This standard applies to equipment that generates hundreds to millions of independent reaction units for nucleic acid samples in the form of single droplets or single nucleic acid molecules. The analysis system includes microdroplet generation modules, polymerase chain reaction modules and microdroplet detection modules. wait. | YY/T 1918-2023: Digital polymerase chain reaction analysis system---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.
ICS 11.100.10
CCSC44
Pharmaceutical Industry Standards of the People's Republic of China
Digital polymerase chain reaction analysis system
Published on 2023-09-05
Implemented on 2024-09-15
Released by the State Drug Administration
Foreword
This document complies with the provisions of GB/T 1.1-2020 "Standardization Work Guidelines Part 1.Structure and Drafting Rules of Standardization Documents"
Drafting.
Please note that some content in this document may be subject to patents. Release of this document
The Agency assumes no responsibility for identifying patents.
This document is proposed by the National Medical Products Administration.
This document is under the jurisdiction of the National Standardization Technical Committee for Medical Clinical Laboratory and In Vitro Diagnostic Systems (SAC/TC136).
This document was drafted by. Beijing Institute of Medical Device Inspection (Beijing Medical Biological Protection Equipment Inspection and Research Center), China Food
Institute for Drug Control, Beijing Medical Device Evaluation and Inspection Center, Beijing Xinyi Biotechnology Co., Ltd., Guangdong Yongnuo Medical Technology Co., Ltd.
Company, Bole Life Medical Products (Shanghai) Co., Ltd., Beijing Da Microbiology Technology Co., Ltd., Suzhou Sinafu Medical Technology Co., Ltd.,
Chongqing Geneshengzi Biotechnology Co., Ltd.
The main drafters of this document. Li Da, Huang Jie, Zhou Haiwei, Sun Rong, Su Shisheng, Xu Shaofei, Wang Ruixia, Liu Jingwen, Fu Jun, Wu Kun, Yuan Chengbin.
Digital polymerase chain reaction analysis system
1 Scope
This document specifies the classification, requirements, test methods, labels, and labeling of digital polymerase chain reaction analysis systems (hereinafter referred to as digital PCR).
Instructions for use, packaging, transportation and storage, etc.
This document is applicable to devices that generate hundreds to millions of independent reaction units for nucleic acid samples in a single droplet or single nucleic acid molecule.
The equipment and analysis system include micro droplet generation module, polymerase chain reaction module and micro droplet detection module.
2 Normative reference documents
The contents of the following documents constitute essential provisions of this document through normative references in the text. Among them, the dated quotations
For undated referenced documents, only the version corresponding to that date applies to this document; for undated referenced documents, the latest version (including all amendments) applies to
this document.
GB/T 191 Packaging, storage and transportation pictorial mark
GB 4793.1 Safety requirements for electrical equipment for measurement, control and laboratory use Part 1.General requirements
GB 4793.6 Safety requirements for electrical equipment for measurement, control and laboratory use Part 6.Characteristics of laboratory material heating equipment
Special requirements
GB 4793.9 Safety requirements for electrical equipment for measurement, control and laboratory use Part 9.Laboratory use for analysis and other purposes
Special requirements for automatic and semi-automatic equipment
GB/T 14710 Environmental requirements and test methods for medical electrical appliances
GB/T 18268.1 Electromagnetic compatibility requirements for electrical equipment for measurement, control and laboratory use Part 1.General requirements
GB/T 18268.26 Electromagnetic compatibility requirements for electrical equipment for measurement, control and laboratory use Part 26.Special requirements
In vitro diagnostic (IVD) medical equipment
GB/T 29791.3 Information provided by manufacturers of in vitro diagnostic medical devices (labeling) Part 3.Professional in vitro diagnostic instruments
YY 0648 Safety requirements for electrical equipment for measurement, control and laboratory use Part 2-101.In vitro diagnostic (IVD) medical equipment
special requirements
3 Terms and definitions
The following terms and definitions apply to this document.
3.1
Disperse nucleic acid samples into thousands of equal-volume reaction units, which contain 0, 1, or multiple nucleic acid molecules.
polymerase chain reaction.
Note. An absolute quantification technology for nucleic acid molecules that does not require a standard curve, which can directly give the copy number of DNA or RNA molecules, which is the concentration of the starting nucleic acid sample.
absolute quantification.
3.2
Instruments and equipment that implement digital polymerase chain reaction and data analysis processes. Specific steps include the generation of reaction units, polymerase chain reaction
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