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YY/T 1893-2023: Y chromosome microdeletions detection kit
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| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY/T 1893-2023 | English | 139 |
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Y chromosome microdeletions detection kit
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YY/T 1893-2023
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Basic data | Standard ID | YY/T 1893-2023 (YY/T1893-2023) | | Description (Translated English) | Y chromosome microdeletions detection kit | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C44 | | Classification of International Standard | 11.100.10 | | Word Count Estimation | 7,767 | | Date of Issue | 2023-09-05 | | Date of Implementation | 2024-09-15 | | Issuing agency(ies) | State Drug Administration | | Summary | This standard specifies the requirements, test methods, labels and instructions for use, packaging, transportation and storage of Y chromosome microdeletion detection kits. This standard applies to Y chromosome microdeletion detection kits such as PCR-fluorescent probe method, PCR-capillary electrophoresis method, and biochip method. This document does not apply to detection kits based on next-generation sequencing methods. | YY/T 1893-2023: Y chromosome microdeletions detection kit---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
Y chromosome microdeletion detection kit
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 contents of this document may involve patents, and the issuing organization of this document does not assume the 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. China Institute of Food and Drug Control, Henan Institute of Drug and Medical Device Inspection, Beijing Institute of Medical Device Inspection
Research Institute (Beijing Medical Biological Protective Equipment Inspection and Research Center), Peking Union Medical College Hospital of the Chinese Academy of Medical Sciences, and Yuer Gene Technology (Suzhou) have
Co., Ltd., Yaneng Biotechnology (Shenzhen) Co., Ltd., Guangzhou Daan Gene Co., Ltd., and Shanghai Toujing Life Technology Co., Ltd.
The main drafters of this document. Yu Ting, Zhang Juanli, Sun Li, Yang Zhuo, Luo Junfeng, Han Jingyan, Lei Shuying, Liu Nansong, Jiang Xiwen, He Lirong,
Guo Anliang, Qu Shoufang, Sun Nan, Hu Zebin.
Y chromosome microdeletion detection kit
1 Scope
This document specifies the requirements, test methods, labeling and instructions for use, packaging, transportation and storage of Y chromosome microdeletion detection kits.
This document is applicable to Y chromosome microdeletion detection kits such as PCR-fluorescent probe method, PCR-capillary electrophoresis method, and biochip method.
(hereinafter referred to as "test kit").
This document does not apply to detection kits based on next-generation sequencing methods.
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/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
There are no terms or definitions to be defined in this document.
4 requirements
4.1 Appearance
Manufacturers should specify appropriate appearance requirements based on the packaging characteristics of the product. Generally, the kit should include the composition, properties, inner and outer packaging of each component.
requirements for packaging and clear labeling.
4.2 Detection limit
Test the national reference products or enterprise detection limit reference products whose total DNA content is not higher than 15ng/reaction or 3000 white blood cells/reaction.
The results should be consistent with the expected results.
4.3 Compliance rate of positive reference products
When testing national positive reference products or corporate positive reference products, the results should be consistent with the corresponding Y chromosome microdeletion type.
4.4 Compliance rate of negative reference products
When testing national negative reference materials or corporate negative reference materials, the result should be that no Y chromosome is detected or no Y chromosome is detected within the detection range of the kit.
Chromosomal microdeletion type.
4.5 Repeatability
Test the enterprise's repetitive reference products 10 times each. The results of the same repetitive reference product should be consistent, and the requirements are.
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