YY/T 1800-2021 English PDF

US$199.00 · In stock
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YY/T 1800-2021: (Deafness gene mutation detection kit)
Status: Valid

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
YY/T 1800-2021	199	Add to Cart	3 days	(Deafness gene mutation detection kit)	Valid

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Basic data

Standard ID: YY/T 1800-2021 (YY/T1800-2021)
Description (Translated English): (Deafness gene mutation detection kit)
Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard: C40
Word Count Estimation: 9,936
Issuing agency(ies): State Drug Administration

YY/T 1800-2021: (Deafness gene mutation 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.
(Deafness gene mutation detection kit) ICS 11.100.10 C40 People's Republic of China Pharmaceutical Industry Standard Deafness gene mutation detection kit Published on 2021-09-06 2023-03-01 Implementation Released 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 some content of this document may be patented. Publication of this document Institutions do not assume responsibility for identifying these patents. This standard is proposed by the State Drug Administration. This standard is under the jurisdiction of the National Standardization Technical Committee of Medical Clinical Laboratory and In Vitro Diagnostic System (SAC/TC136). This standard was drafted by. China National Institute for Food and Drug Control, Henan Medical Device Inspection Institute, Shenzhen Huada Zhizao Technology Co., Ltd., Guangzhou Darui Biotechnology Co., Ltd., Shandong Yingsheng Biotechnology Co., Ltd., Guangzhou Kaipu Pharmaceutical Technology Co., Ltd., Zhongsheng North Control Biotechnology Co., Ltd., Guangzhou Jinqirui Biotechnology Co., Ltd., Beijing Bohui Innovation Biotechnology Co., Ltd. company. The main drafters of this standard. Yu Ting, Zhang Juanli, Zou Jing, Wu Yingsong, Feng Zhen, Zheng Yan, Huang Qian, Chen Jiachang, Liu Chunxia, Huang Jie, Qu Shoufang, Jia Zheng. Deafness gene mutation detection kit

1 Scope

This standard specifies the requirements, test methods, labels and instructions for use, packaging, transportation and storage of deafness gene mutation detection kits. This standard applies to chip method, mass spectrometry, PCR method (such as fluorescent PCR method, PCR-fluorescent probe method, fluorescent PCR melting curve method etc.) and other deafness gene mutation detection kits, which are not suitable for deafness gene mutation detection kits based on the sequencing method.

2 Normative references

The following documents are essential for the application of this document. For dated references, only the dated version applies to this article pieces. For undated references, the latest edition (including all amendments) applies to this document. GB/T 191 Graphical signs of packaging, storage and transportation GB/T 29791.2 Information provided by manufacturers of in vitro diagnostic medical devices (labeling) Part 2.In vitro diagnostic reagents for professional use

3 Requirements

3.1 Appearance Manufacturers should specify appropriate appearance requirements according to the packaging characteristics of their products. Generally, the composition and properties of each component of the kit should be Requirements for packaging, clear labels, etc. 3.2 Detection limit The following requirements should be met. a) For the chip method, the detection limit should be no higher than 20ng/reaction or 2ng/μL; for mass spectrometry, the detection limit should be no higher than 5ng/reaction or 1ng/μL; for fluorescent PCR methods (such as fluorescent PCR method, PCR-fluorescent probe method, fluorescent PCR melting curve method, etc.), The detection limit should not be higher than 10ng/reaction or 2ng/μL. The detection limit should not be higher than 15ng/reaction or 1ng/μL; b) The results of detecting the national positive reference substance or the enterprise detection limit reference substance within the detection range of the kit diluted to the detection limit concentration shall be match the corresponding genotype. Note 1.The detection limit of other principle kits can be set by referring to a) in 3.2. Note 2.The test results can only meet one of the two indicators of total reaction volume or concentration. Note 3.There is no requirement for the detection limit of mtDNA12SrRNA mutation percentage for the time being. release, and self-confirm the detection limit of mutation percentage of the kit. Note 4.For the description of the national reference products involved in this standard, please refer to Appendix A, the same below. 3.3 Accuracy The results of national positive reference products or enterprise positive reference products within the detection range of the detection kit should conform to the corresponding genotype. 3.4 Specificity When testing national negative reference materials and national positive reference materials outside the detection range of the kit, or testing enterprise negative reference materials, the results should be ......

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