YY/T 1740.1-2021 English PDFUS$249.00 ยท In stock
Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email. YY/T 1740.1-2021: Clinical mass spectrometer - Part 1: Liquid chromatography-mass spectrometer Status: Valid
Basic dataStandard ID: YY/T 1740.1-2021 (YY/T1740.1-2021)Description (Translated English): Clinical mass spectrometer - Part 1: Liquid chromatography-mass spectrometer Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended) Classification of Chinese Standard: C44 Word Count Estimation: 13,111 Issuing agency(ies): State Drug Administration YY/T 1740.1-2021: Clinical mass spectrometer - Part 1: Liquid chromatography-mass spectrometer---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.Clinical mass spectrometer - Part 1.Liquid chromatography-mass spectrometer ICS 11.100 C44 People's Republic of China Pharmaceutical Industry Standards Medical mass spectrometer Part 1.Liquid Chromatography-Mass Spectrometer Released on 2021-03-09 2022-10-01 implementation Issued by the National Medical Products Administration ForewordYY/T 1740 "Medical Mass Spectrometer" is divided into 4 parts. ---Part 1.Liquid chromatography-mass spectrometry; ---Part 2.Matrix-assisted laser desorption ionization time-of-flight mass spectrometer; ---Part 3.Gas chromatography-mass spectrometry; ---Part 4.Inorganic mass spectrometer. This part is part 1 of YY/T 1740. This section 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 agency of this document is not responsible for identifying these patents. This part was proposed by the State Drug Administration. This part is under the jurisdiction of the National Medical Clinical Laboratory and In Vitro Diagnostic System Standardization Technical Committee (SAC/TC136). Drafting organizations of this section. Beijing Institute of Medical Device Inspection, Beijing Tongren Hospital Affiliated to Capital Medical University, Clinical Laboratory Center of the Ministry of Health, Peking Union Medical College Hospital, Guangzhou Jinyu Medical Laboratory Group Co., Ltd., Mecang Biotechnology Co., Ltd. The main drafters of this section. Peng Xu, Li Shengmin, Liu Xiangyi, Zhang Tianjiao, Cheng Xinqi, Zhao Beibei, Shen Min, Zou Yingshu. Medical mass spectrometer Part 1.Liquid Chromatography-Mass Spectrometer1 ScopeThis part of YY/T 1740 specifies the requirements, test methods, labels, instructions for use, packaging, Transportation and storage. This part is applicable to single quadrupole and triple quadrupole liquid chromatography-mass spectrometer (hereinafter referred to as liquid chromatography-mass spectrometer), which mainly It is used to analyze molecular substances in human samples such as blood and urine, such as proteins, small metabolic molecules, drugs, etc.2 Normative referencesThe following documents are indispensable for the application of this document. For dated reference documents, only the dated version applies to this article Pieces. For undated reference documents, the latest version (including all amendments) is applicable to this document. GB/T 191 Packaging, storage and transportation pictorial signs GB 4793.1 Safety requirements for electrical equipment for measurement, control and laboratory use Part 1.General requirements GB 4793.6 Safety requirements for electrical equipment for measurement, control and laboratory use Part 6.Characteristics of material heating equipment for laboratory use Special requirements GB 4793.9 Safety requirements for electrical equipment for measurement, control and laboratory use-Part 9.Laboratory use for analysis and other purposes Special requirements for mobile and semi-automatic equipment GB/T 14710 Environmental requirements and test methods for medical electrical appliances GB/T 18268.1 Electromagnetic compatibility requirements for electrical equipment for measurement, control and laboratory use-Part 1.General requirements GB/T 18268.26 Electromagnetic compatibility requirements for electrical equipment for measurement, control and laboratory use Part 26.Special requirements External diagnostic (IVD) medical equipment GB/T 29791.3 Information provided by manufacturers of in vitro diagnostic medical devices (labeling) Part 3.In vitro diagnostic devices for professional use YY 0648 Safety requirements for electrical equipment for measurement, control and laboratory use Part 2-101.In vitro diagnostic (IVD) medical equipment Dedicated requirements3 Terms and definitionsThe following terms and definitions apply to this document. 3.1 Massaccuracy The deviation between the mass spectrometer's measured value of ion mass and the theoretical value. [GB/T 32267-2015, definition 4.5] 3.2 Masschargeratio,m/z The ratio of the mass of an ion (m) to the number of charges it carries (z). [GB/T 32267-2015, definition 4.6] ......Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of YY/T 1740.1-2021_English be delivered?Answer: Upon your order, we will start to translate YY/T 1740.1-2021_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 1740.1-2021_English with my colleagues?Answer: Yes. The purchased PDF of YY/T 1740.1-2021_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+ countriesQuestion 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. |