HOME   Cart(0)   Quotation   About-Us Policy PDFs Standard-List
www.ChineseStandard.net Database: 189760 (25 Oct 2025)

YY/T 1586-2018 English PDF

US$119.00 ยท In stock
Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email.
YY/T 1586-2018: Individualized treatment tumor related gene mutation detection kit(Fluorescent PCR)
Status: Valid
Standard IDContents [version]USDSTEP2[PDF] delivered inStandard Title (Description)StatusPDF
YY/T 1586-2018English119 Add to Cart 3 days [Need to translate] Individualized treatment tumor related gene mutation detection kit(Fluorescent PCR) Valid YY/T 1586-2018

PDF similar to YY/T 1586-2018


Standard similar to YY/T 1586-2018

YY/T 1579   YY/T 1578   YY/T 1581   YY/T 1585   

Basic data

Standard ID YY/T 1586-2018 (YY/T1586-2018)
Description (Translated English) Individualized treatment tumor related gene mutation detection kit(Fluorescent PCR)
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C44
Classification of International Standard 11.100
Word Count Estimation 6,652
Date of Issue 2018-02-24
Date of Implementation 2019-03-01
Quoted Standard GB/T 29791.2
Regulation (derived from) China Food and Drug Administration announced No. 27 of 2018
Issuing agency(ies) State Food and Drug Administration
Summary The current standard specifies the requirements, test methods, labels, instructions for use, packaging, transportation, and storage of the individual gene therapy-related gene mutation detection kits for tumors. This standard applies to nucleic acid detection techniques for real-time fluorescent PCR methods for individualized mutation-related gene therapy in tumors. The types of gene mutations referred to in this standard include base substitutions, transversions, insertions, deletions, and the like.

YY/T 1586-2018: Individualized treatment tumor related gene mutation detection kit(Fluorescent PCR)


---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.
Individualized treatment tumor related gene mutation detection kit(Fluorescent PCR) ICS 11.100 C44 People's Republic of China Pharmaceutical Industry Standard Tumor individualized treatment related gene mutation detection kit (fluorescence PCR method) (FluorescentPCR) Published on.2018-02-24 2019-03-01 implementation State Food and Drug Administration issued

Foreword

This standard was drafted in accordance with the rules given in GB/T 1.1-2009. Please note that some of the contents of this document may involve patents. The issuing organization of this document is not responsible for identifying these patents. This standard was proposed by the State Food and Drug Administration. This standard is under the jurisdiction of the National Medical Clinical Laboratory and the In vitro Diagnostic System Standardization Technical Committee (SAC/TC136). This standard was drafted. Beijing Medical Device Inspection Institute, Zhongshan University Daan Gene Co., Ltd., Roche Diagnostics (Shanghai) Co., Ltd., Hunan Shengxiang Biotechnology Co., Ltd. The main drafters of this standard. Zhang Ligang, Wang Ruixia, Gao Xunian, Cai Xiaorong, Deng Zhongping. Tumor individualized treatment related gene mutation detection kit (fluorescence PCR method)

1 Scope

This standard specifies the requirements, test methods, labels, instructions for use, and kits for the detection of gene mutation detection kits for individualized treatment of tumors. Loading, transport and storage. This standard applies to the nucleic acid detection technology of real-time fluorescent PCR method for gene mutation related to tumor individualized treatment. The types of gene mutations referred to in this standard include base substitution, transversion, insertion, deletion, and the like.

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. GB/T 29791.2 Information provided by in vitro diagnostic medical device manufacturers (labeling) Part 2. Professional in vitro diagnostic reagents

3 requirements

3.1 Appearance The components of the kit should be complete and complete, and the liquid should be free of leakage. 3.2 Positive coincidence rate Positive national reference products and/or standardized enterprise reference products within the scope of the test kit, the test results should be positive and consistent with the corresponding Variable type. The setting of positive reference products should follow the following principles. a) all types of mutations detectable within the scope of the kit; b) 3 mutation percentage gradients for each mutation site, weak positive reference. no more than 3 times the detection limit mutation rate; medium positive Reference product. mutation rate is not higher than 40%; strong positive reference product. mutation rate is not less than 70%; c) In the positive reference composition used, the matrix of the common mutation site reference should be the same or similar to the actual test sample matrix. 3.3 Negative compliance rate Test negative national reference products and/or standardized enterprise reference products, the test results should be negative or wild type. The setting of the negative reference should follow the following principles. a) should contain a certain number of non-human genome samples. common microbial samples; b) wild-type samples without corresponding target mutant sequences; c) Genotype or gene mutation samples outside the scope of the kit design. 3.4 Detection limit National reference products and/or standardized enterprise reference products within the scope of the test kit, the test results should be positive and consistent with the corresponding mutation

Tips & Frequently Asked Questions:

Question 1: How long will the true-PDF of YY/T 1586-2018_English be delivered?

Answer: Upon your order, we will start to translate YY/T 1586-2018_English as soon as possible, and keep you informed of the progress. The lead time is typically 1 ~ 3 working days. The lengthier the document the longer the lead time.

Question 2: Can I share the purchased PDF of YY/T 1586-2018_English with my colleagues?

Answer: Yes. The purchased PDF of YY/T 1586-2018_English will be deemed to be sold to your employer/organization who actually pays for it, including your colleagues and your employer's intranet.

Question 3: Does the price include tax/VAT?

Answer: Yes. Our tax invoice, downloaded/delivered in 9 seconds, includes all tax/VAT and complies with 100+ countries' tax regulations (tax exempted in 100+ countries) -- See Avoidance of Double Taxation Agreements (DTAs): List of DTAs signed between Singapore and 100+ countries

Question 4: Do you accept my currency other than USD?

Answer: Yes. If you need your currency to be printed on the invoice, please write an email to [email protected]. In 2 working-hours, we will create a special link for you to pay in any currencies. Otherwise, follow the normal steps: Add to Cart -- Checkout -- Select your currency to pay.