YY/T 1893-2023 English PDF

US$139.00 · In stock
Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email.
YY/T 1893-2023: Y chromosome microdeletions detection kit
Status: Valid

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
YY/T 1893-2023	139	Add to Cart	3 days	Y chromosome microdeletions detection kit	Valid

Similar standards

YY/T 1713   YY/T 1709   YY/T 1721   YY/T 1902   YY/T 1892   

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. ......

Image     

Tips & Frequently Asked Questions:

Question 1: How long will the true-PDF of YY/T 1893-2023_English be delivered?

Answer: Upon your order, we will start to translate YY/T 1893-2023_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 1893-2023_English with my colleagues?

Answer: Yes. The purchased PDF of YY/T 1893-2023_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 Sales@ChineseStandard.net. 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.