YY/T 1785-2021 English PDF

US$259.00 · In stock
Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email.
YY/T 1785-2021: (Amino acid and carnitine detection kit (tandem mass spectrometry))
Status: Valid

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
YY/T 1785-2021	259	Add to Cart	3 days	(Amino acid and carnitine detection kit (tandem mass spectrometry))	Valid

Similar standards

YY/T 1713   YY/T 1709   YY/T 1721   YY/T 1786   YY/T 1784   

Basic data

Standard ID: YY/T 1785-2021 (YY/T1785-2021)
Description (Translated English): (Amino acid and carnitine detection kit (tandem mass spectrometry))
Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard: C44
Word Count Estimation: 12,190
Issuing agency(ies): State Drug Administration

YY/T 1785-2021: (Amino acid and carnitine detection kit (tandem mass spectrometry))

---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.
(Amino acid and carnitine detection kit (tandem mass spectrometry)) ICS 11.100.10 C44 People's Republic of China Pharmaceutical Industry Standard Amino acid and carnitine detection kit (tandem mass spectrometry) 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, Shenzhen Huada Gene Co., Ltd., Guangzhou Darui Biotechnology Co., Ltd. Co., Ltd., Beijing Huada Jibei Biotechnology Co., Ltd., Chinese People's Liberation Army General Hospital, PerkinElmer Medical Diagnostic Products (Part 1) Hai) Co., Ltd., Guangzhou Fenghua Biological Engineering Co., Ltd., Beijing Bohui Innovation Biotechnology Co., Ltd. The main drafters of this standard. Qu Shoufang, Yan Miaoli, Wu Yingsong, Zhang Shenyan, Tian Yaping, Jiang Kuan, Wang Qin, Lu Xiangdong, Huang Jie, Yu Ting. Amino acid and carnitine detection kit (tandem mass spectrometry)

1 Scope

This standard specifies the requirements, test methods, labels and instructions for use, packaging, transportation and storage, etc. This standard applies to kits for quantitative detection of amino acids and carnitine in dried blood film samples of neonatal filter paper by tandem mass spectrometry, including Non-derivatized and derivatized methods.

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 191-2008 Graphical signs of packaging, storage and transportation GB/T 29791.2-2013 Information provided by manufacturers of in vitro diagnostic medical devices (labeling) - Part 2.In vitro diagnostics for professional use break reagent

3 Requirements

3.1 Appearance The components of the kit should be complete and complete without liquid leakage. 3.2 Accuracy The accuracy should meet one of the following requirements. a) Using the reference material as a sample for testing, the relative deviation of the measurement results should be within the range of ±20.0%; b) The recovery of each analyte should be between 80.0% and 120.0% or meet the requirements claimed by the manufacturer. Note 1.For the description of the national standard products involved in this standard, please refer to Appendix A. Note 2.See Appendix B for analytes whose recoveries should be between 80.0% and 120.0%, and Appendix A and Appendix B for analytes that meet the requirements claimed by the manufacturer. Not listed. 3.3 Linear Within the linear interval of each analyte claimed by the manufacturer, the linear correlation coefficient (r) of the corresponding analyte should not be less than 0.9900. 3.4 Precision 3.4.1 Intra-assay precision The CV (%) of each analyte test result should not be greater than 20.0%. 3.4.2 Between-assay precision The CV (%) of each analyte test result should not be greater than 25.0%. ......

Image     

Tips & Frequently Asked Questions:

Question 1: How long will the true-PDF of YY/T 1785-2021_English be delivered?

Answer: Upon your order, we will start to translate YY/T 1785-2021_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 1785-2021_English with my colleagues?

Answer: Yes. The purchased PDF of YY/T 1785-2021_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.